Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 1215 for:    "Hodgkin lymphoma"

Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00352027
Recruitment Status : Active, not recruiting
First Posted : July 14, 2006
Results First Posted : October 7, 2016
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hodgkin's Lymphoma
Interventions Drug: Adriamycin®
Drug: Vinblastine
Drug: Nitrogen Mustard
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Bleomycin
Drug: Etoposide
Drug: Prednisone
Biological: G-CSF
Procedure: Radiotherapy
Enrollment 81
Recruitment Details Participants were enrolled between July 2006 and March 2012.
Pre-assignment Details One participant was determined to be ineligible after enrollment and prior to start of therapy.
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Period Title: Overall Study
Started 80
Completed 77
Not Completed 3
Reason Not Completed
Progressive disease             3
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
15.10  (3.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
46
  57.5%
Male
34
  42.5%
Participating Site Location  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants
Dana Farber Cancer Institute, Boston, MA 21
Main Medical Center, Portland, ME 2
Massachusetts General Hospital, Boston, MA 1
Rady Children's Hospital, San Diego, CA 1
St. Jude Children's Research Hospital, Memphis, TN 33
Stanford University Medical Center, Palo Alto, CA 22
1.Primary Outcome
Title 3-year Event-Free Survival Probability
Hide Description The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description:

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.887
(0.821 to 0.959)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stanford V Chemotherapy
Comments The association of age with EFS was compared. P values from Score test were computed for the statistical significance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9970
Comments [Not Specified]
Method Cox Model
Comments [Not Specified]
2.Secondary Outcome
Title Disease Failure Rate Within Radiation Fields
Hide Description Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description:

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.1125
(0.05591 to 0.2076)
3.Secondary Outcome
Title Local and Distant Failure for Children Treated With Tailored-field Radiation
Hide Description The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.
Time Frame from first enrollment date up to 3 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description:

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability that the event occurs
Cumulative incidence of distant failure at 3 years
0.0375
(0.0099 to 0.0967)
Cumulative incidence of local failure at 3 years
0.1127
(0.0550 to 0.1932)
4.Secondary Outcome
Title Prognostic Factors for Treatment Failure: Age
Hide Description Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.
Time Frame 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description:

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: events
11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stanford V Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9970
Comments [Not Specified]
Method Cox Model
Comments [Not Specified]
5.Secondary Outcome
Title Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy
Hide Description [Not Specified]
Time Frame 1, 2, 5, and 10 years post therapy
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.4.0: Total Score
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 58 58 54 38 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
80.9  (12.7) 74.4  (16.5) 75.3  (17.8) 83.1  (14.6) 84.5  (16.6)
7.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 61 60 57 40 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
83.2  (17.1) 68.4  (23.1) 69.1  (24.6) 80.8  (17.1) 85.2  (15.6)
8.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 59 58 54 38 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.3  (13) 77.6  (15.4) 78.6  (16.8) 84.3  (15.1) 84.3  (17.9)
9.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 61 60 57 40 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
72.6  (18.0) 75.3  (19.3) 75.7  (20.8) 84.5  (17.8) 81.6  (24.1)
10.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 62 60 57 40 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
90.9  (11.1) 88.6  (13.0) 88.0  (15.6) 90.1  (12.5) 91.1  (13.6)
11.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 60 58 54 38 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.1  (18.8) 69.5  (21.8) 72.6  (22.2) 78.4  (20.6) 81.3  (21.6)
12.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.3.0: Total Score
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 60 57 37 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
74.1  (15.3) 74.2  (16.8) 81.7  (14.6) 83.5  (17.2)
13.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 61 57 41 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
63.9  (25.4) 71.5  (24.6) 79.9  (25.1) 88.0  (17.8)
14.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.3.0: Nausea
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 61 57 41 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
62.7  (24.0) 60.1  (23.5) 76.7  (20.9) 81.6  (23.1)
15.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 60 57 40 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
71.8  (29.0) 70.9  (32.6) 68.1  (37.3) 80.1  (25.9)
16.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 61 57 41 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
89.2  (15.5) 82  (22.5) 89.4  (16.6) 87.3  (19.1)
17.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.3.0: Worry
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 61 57 41 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
71.2  (22.5) 72.2  (24.7) 74.5  (27.2) 76.0  (25.0)
18.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 61 57 41 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.1  (19.4) 78.2  (21.4) 87.0  (17.3) 82.0  (23.2)
19.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 61 57 38 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.6  (22.1) 81.3  (22.6) 81.4  (22.4) 84.7  (22.9)
20.Secondary Outcome
Title Patient Quality of Life (QoL), PedsQL v.3.0: Communication
Hide Description

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 61 57 39 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
80.7  (19.9) 83.0  (22.5) 87.2  (22.8) 89.0  (19.3)
21.Secondary Outcome
Title Patient Quality of Life (QoL), Symptom Distress Scale
Hide Description

The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.

Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 57 59 52 40 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.3  (6.5) 19.6  (6.6) 18.1  (6.1) 15.1  (4.8) 14.3  (5.3)
22.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 61 52 50 36 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.6  (16.7) 69.1  (17.9) 72.3  (18.5) 77.8  (16.3) 83.5  (16.4)
23.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 64 58 56 40 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.8  (20.7) 65.3  (23.2) 67.3  (25.2) 73.6  (21.3) 84.6  (18.6)
24.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 61 52 50 36 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
76.2  (16.8) 71.0  (16.7) 74.1  (17.9) 79.0  (16.1) 88.0  (17.0)
25.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 64 58 56 40 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
67.7  (20.4) 65.4  (18.4) 68.1  (23.7) 73.0  (20.1) 82.0  (18.9)
26.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 64 58 56 40 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
86.1  (18.6) 83.0  (16.0) 80.7  (18.5) 85.1  (16.3) 89.1  (16.8)
27.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.
Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 61 52 50 36 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
74.4  (20.6) 62.8  (25.0) 70.8  (22.7) 75.6  (20.8) 78.9  (21.2)
28.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 56 55 37 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
71.7  (16.7) 69.3  (19.0) 74.5  (17.7) 80.0  (16.4)
29.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 58 56 40 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
61.2  (24.3) 61.8  (30.5) 73.1  (25.9) 82.7  (23.4)
30.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 58 57 39 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
61.2  (24.4) 57.4  (29.2) 72.2  (26.6) 83.2  (22.6)
31.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 58 55 40 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
70.0  (32.1) 60.0  (35.0) 63.1  (36.6) 73.8  (31.7)
32.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 57 56 40 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
81.9  (21.8) 72.6  (28.4) 78.5  (26.8) 81.8  (20.8)
33.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 58 56 40 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
70  (24.5) 69.2  (25.3) 71.9  (24.1) 78.7  (19.4)
34.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 57 55 40 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.6  (21.8) 79.5  (20.4) 78.6  (21.8) 79.9  (23.4)
35.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 58 56 38 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
74.9  (22.9) 72.2  (21.9) 73.7  (24.2) 76.3  (24.4)
36.Secondary Outcome
Title Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication
Hide Description Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.
Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Pre-therapy Week 8 Week 12 After Radiation Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 58 56 38 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.2  (25.9) 80.4  (24.9) 80.3  (22.6) 84.3  (20.3)
37.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 57 50 49 34 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.9  (13.3) -4.8  (13.8) -4.8  (14.7) -5  (10.7) -2.9  (14.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Pre-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.265
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.680
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
38.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 60 56 55 37 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.9  (16.4) -2.3  (16.9) -1.9  (23.3) -5.4  (15.8) -2  (19.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Pre-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.563
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.563
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.563
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.184
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.563
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
39.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 58 50 49 34 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.8  (14.4) -6.4  (14.4) -6.3  (13.2) -5.6  (11.2) -3.3  (14.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Pre-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
40.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 60 56 55 37 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.9  (18.8) -9.4  (17.9) -8.0  (14.2) -10.8  (14.3) -1.7  (18.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Pre-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.707
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
41.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 61 56 55 37 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.3  (16.5) -5.7  (15.3) -7.4  (17.7) -5.0  (12.6) -3.3  (16.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Pre-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.243
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
42.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 59 50 49 34 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.3  (17.0) -5.3  (19.5) -4.1  (21.0) -3.4  (16.7) -4.3  (16.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Pre-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.546
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.242
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.372
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.503
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.372
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
43.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 53 54 33 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (13) -5.2  (13.8) -4.5  (12.5) -5  (16.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.558
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
44.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 56 55 38 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.0  (16.5) -9.5  (23.6) -5.6  (23.4) -5.4  (19.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
45.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 56 55 37 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.2  (15.8) -3.4  (21.9) -3.0  (22.4) -1.1  (22.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.629
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.629
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.629
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.858
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
46.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 55 54 38 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (28.1) -9.3  (29.9) -2.2  (32.7) -8.7  (27.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.744
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.512
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
47.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 55 55 38 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.1  (21.9) -8.8  (26.4) -7.9  (23.7) -6.6  (26.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
48.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 56 55 38 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (21.7) -3.9  (26.5) -2.7  (20.4) -0.5  (19.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.739
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.739
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.739
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.739
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
49.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 55 54 38 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (20.7) 0.14  (19) -8.0  (19) -4.0  (20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.933
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.933
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0779
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
50.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 56 55 34 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.5  (21.0) -9.5  (22.5) -5.9  (25.7) -9.3  (20.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.415
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
51.Secondary Outcome
Title Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication
Hide Description

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Time Frame At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.
Arm/Group Title Parent and Patient Scores at Pre-therapy Parent and Patient Scores at Week 8 Parent and Patient Scores at Week 12 Parent and Patient Scores at After Radiation Parent and Patient Scores at Off-therapy
Hide Arm/Group Description:
Evaluation completed prior to the start of treatment.
Evaluation completed following 2 courses of therapy, approximately week 8 after start.
Evaluation completed following 4 courses of therapy, approximately week 16 after start.
Evaluation completed following radiation therapy.
Evaluation completed approximately 3-6 months following completion of therapy.
Overall Number of Participants Analyzed 0 56 55 35 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (26.4) -3.6  (25.2) -7.4  (25.5) -6.3  (21.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.814
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.553
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at After Radiation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Parent and Patient Scores at Off-therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments P-values are shown after correction for multiple testing using the False Discovery Rate Method.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
52.Secondary Outcome
Title Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score
Hide Description

Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Time Frame 6 months after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.
Arm/Group Title QoL Participants
Hide Arm/Group Description:
All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: beta coefficient
-1.46
(-1.64 to -1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QoL Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized Estimating Equations (GEE)
Comments [Not Specified]
53.Secondary Outcome
Title Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning
Hide Description

Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Time Frame 6 months after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.
Arm/Group Title QoL Participants
Hide Arm/Group Description:
All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: beta coefficient
-1.9
(-2.27 to -1.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QoL Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generallized Estimating Equations (GEE)
Comments [Not Specified]
54.Secondary Outcome
Title Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health
Hide Description

Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Time Frame 6 months after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.
Arm/Group Title QoL Participants
Hide Arm/Group Description:
All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: beta coefficient
-0.92
(-1.26 to -0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QoL Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generallized Estimating Equations (GEE)
Comments [Not Specified]
55.Secondary Outcome
Title Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning
Hide Description

Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Time Frame 6 months after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.
Arm/Group Title QoL Participants
Hide Arm/Group Description:
All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: beta coefficient
-1.56
(-1.95 to -1.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QoL Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generallized Estimating Equations (GEE)
Comments [Not Specified]
56.Secondary Outcome
Title Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning
Hide Description

Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Time Frame 6 months after the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.
Arm/Group Title QoL Participants
Hide Arm/Group Description:
All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: beta coefficient
-0.79
(-0.98 to -0.59)