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Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

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: NCT00354835
Recruitment Status : Unknown
Verified December 2016 by Children's Oncology Group.
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2006
Results First Posted : July 25, 2017
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Malignant Mesenchymoma
Adult Rhabdomyosarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Botryoid-Type Embryonal Rhabdomyosarcoma
Childhood Embryonal Rhabdomyosarcoma
Childhood Malignant Mesenchymoma
Non-Metastatic Childhood Soft Tissue Sarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Untreated Childhood Rhabdomyosarcoma
Interventions Drug: Irinotecan Hydrochloride
Biological: Dactinomycin
Drug: Cyclophosphamide
Drug: Vincristine Sulfate
Radiation: Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Enrollment 481
Recruitment Details  
Pre-assignment Details 481 excludes 33 ineligible cases (declared by the Study Chair) .
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With Vincristine, Irinotecan (VI)
Hide Arm/Group Description

Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.

Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies

Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Period Title: Overall Study
Started 239 242
Completed 187 181
Not Completed 52 61
Reason Not Completed
Death             1             1
Physician Decision             8             13
Withdrawal by Subject             2             1
Ineligible             17             16
Disease progression or relapse             15             22
Adverse Event             6             0
Refusal of further therapy             3             8
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With Vincristine, Irinotecan (VI) Total
Hide Arm/Group Description Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Total of all reporting groups
Overall Number of Baseline Participants 239 242 481
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 239 participants 242 participants 481 participants
89.85  (73.39) 97.86  (82.66) 93.88  (78.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 242 participants 481 participants
Female
109
  45.6%
113
  46.7%
222
  46.2%
Male
130
  54.4%
129
  53.3%
259
  53.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 242 participants 481 participants
Hispanic or Latino
39
  16.3%
28
  11.6%
67
  13.9%
Not Hispanic or Latino
191
  79.9%
204
  84.3%
395
  82.1%
Unknown or Not Reported
9
   3.8%
10
   4.1%
19
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 242 participants 481 participants
American Indian or Alaska Native
2
   0.8%
2
   0.8%
4
   0.8%
Asian
7
   2.9%
7
   2.9%
14
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
37
  15.5%
29
  12.0%
66
  13.7%
White
165
  69.0%
181
  74.8%
346
  71.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
28
  11.7%
23
   9.5%
51
  10.6%
1.Primary Outcome
Title Event Free Survival (EFS)
Hide Description Probability of no relapse, secondary malignancy, or death after 4 year in the study
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With Vincristine, Irinotecan (VI)
Hide Arm/Group Description:

Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.

Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies

Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Overall Number of Participants Analyzed 222 226
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.6255
(0.5575 to 0.6934)
0.5874
(0.5178 to 0.6569)
2.Primary Outcome
Title Response Rate (RR)
Hide Description Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR.
Time Frame Reporting Period 1 (Weeks 1 - 15)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With Vincristine, Irinotecan (VI)
Hide Arm/Group Description:
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Overall Number of Participants Analyzed 222 226
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion
0.6667
(0.6047 to 0.7287)
0.6726
(0.6114 to 0.7337)
3.Primary Outcome
Title Overall Survival (OS)
Hide Description Probability of being alive after 4 years in the study.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With Vincristine, Irinotecan (VI)
Hide Arm/Group Description:
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Overall Number of Participants Analyzed 222 226
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.7293
(0.6669 to 0.7917)
0.7223
(0.6583 to 0.7862)
4.Secondary Outcome
Title Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison
Hide Description Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
17 ineligible participants were excluded.
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC)
Hide Arm/Group Description:
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Overall Number of Participants Analyzed 222
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.6255
(0.5575 to 0.6934)
5.Secondary Outcome
Title Local Failure
Hide Description Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
17 ineligible participants were excluded.
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC)
Hide Arm/Group Description:
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Overall Number of Participants Analyzed 222
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.1757
(0.1256 to 0.2257)
6.Secondary Outcome
Title Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison
Hide Description Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
17 ineligible participants were excluded.
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC)
Hide Arm/Group Description:
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Overall Number of Participants Analyzed 222
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.7293
(0.6669 to 0.7917)
7.Secondary Outcome
Title Incidence of Toxicity
Hide Description Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.
Time Frame Up to 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With Vincristine, Irinotecan (VI)
Hide Arm/Group Description:
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Overall Number of Participants Analyzed 222 226
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.2072
(0.1539 to 0.2605)
0.3673
(0.3044 to 0.4301)
8.Secondary Outcome
Title Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC
Hide Description The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.
Time Frame Up to 43 weeks
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Hide Analysis Population Description
Number of patients with specific adverse events.
Arm/Group Title VAC (Weeks 1-15) VAC (Weeks 31 - 43)
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Reporting period 1 (acute)
Reporting period 3 (late)
Overall Number of Participants Analyzed 222 193
Measure Type: Number
Unit of Measure: participants
Anemia 58 54
Febrile Neutropenia 30 17
Nausea or Hepatopathy 6 1
Platelet Count Decreased 27 63
Vomiting 9 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 1-15)
Comments Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of anemia
Estimated Value 0.2613
Confidence Interval (1-Sided) 95%
0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 1-15)
Comments Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of nausea or hepatopathy
Estimated Value 0.0270
Confidence Interval (1-Sided) 95%
0.0449
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 1-15)
Comments Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of febrile neutropenia
Estimated Value 0.1351
Confidence Interval (1-Sided) 95%
0.1729
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 1-15)
Comments Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of platelet count decrease
Estimated Value 0.1216
Confidence Interval (1-Sided) 95%
0.1577
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 1-15)
Comments Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of vomiting
Estimated Value 0.0405
Confidence Interval (1-Sided) 95%
0.0623
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 31 - 43)
Comments Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of anemia
Estimated Value 0.2798
Confidence Interval (1-Sided) 95%
0.3329
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 31 - 43)
Comments Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of nausea or hepatopathy
Estimated Value 0.0052
Confidence Interval (1-Sided) 95%
0.0137
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 31 - 43)
Comments Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of febrile neutropenia
Estimated Value 0.0881
Confidence Interval (1-Sided) 95%
0.1216
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 31 - 43)
Comments Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of platelet count decrease
Estimated Value 0.3264
Confidence Interval (1-Sided) 95%
0.3819
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection VAC (Weeks 31 - 43)
Comments Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter The incidence of vomiting
Estimated Value 0.0104
Confidence Interval (1-Sided) 95%
0.0224
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4
Hide Description 4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study).
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
452 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 4.
Arm/Group Title % Change in SUVmax From Baseline to Week 4 < 40% % Change in SUVmax From Baseline to Week 4 >= 40%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.2857
(0.0000 to 0.6204)
0.6364
(0.4354 to 0.8374)
10.Secondary Outcome
Title Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15
Hide Description 4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study)
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
421 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 15.
Arm/Group Title % Change in SUVmax From Baseline to Week 15 < 40% % Change in SUVmax From Baseline to Week 15 >= 40%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.6667
(0.2895 to 1.0000)
0.5686
(0.4303 to 0.7070)
11.Secondary Outcome
Title Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype
Hide Description Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.
Time Frame Weeks 4-9 (the first exposure to VI)
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible patients are excluded. Only patients tested for the UGT1A1 genotypes are reported and included in this analysis.
Arm/Group Title UGT1A1 Genotype 6/6 UGT1A1 Genotype 6/7 UGT1A1 Genotype 7/7
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 65 12
Measure Type: Number
Unit of Measure: Counts
Neutropenia, with or without Fever 16 22 4
Diarrhea 5 14 5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UGT1A1 Genotype 6/6, UGT1A1 Genotype 6/7, UGT1A1 Genotype 7/7
Comments The incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection UGT1A1 Genotype 6/6, UGT1A1 Genotype 6/7, UGT1A1 Genotype 7/7
Comments The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Toxicity With CYP2B6 Genotypes
Hide Description Incidence of toxicity related to VAC treatment in patients with CYP2B6 genotypes.
Time Frame During the study
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Hide Analysis Population Description
The analysis was abandoned due to low incidence of toxicity. Data were not collected.
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC)
Hide Arm/Group Description:
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Toxicity With GSTA1 and CYP2C9 Genotypes
Hide Description Incidence of toxicity related to VAC treatment in patients with GSTA1 and CYP2C9 genotypes.
Time Frame During the study
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was abandoned due to low incidence of toxicity. Data were not collected.
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Event Free Survival (EFS) by PAX Status
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients who were tested for their fusion status and PAX partners.
Arm/Group Title PAX3 PAX7
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Fusion positive with PAX3 partner
Fusion positive with PAX7 partner
Overall Number of Participants Analyzed 88 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.51
(0.39 to 0.64)
0.66
(0.37 to 0.94)
15.Secondary Outcome
Title Incidence of Bladder Dysfunction
Hide Description Number of patients with a summary score greater than 8.5
Time Frame 3-6 years after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
470 participants were excluded due to ineligibility or absence of the dysfunctional voiding and incontinence symptoms questionnaire.
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With Vincristine, Irinotecan (VI)
Hide Arm/Group Description:
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
Overall Number of Participants Analyzed 7 4
Measure Type: Number
Unit of Measure: Participant
2 1
Time Frame [Not Specified]
Adverse Event Reporting Description All eligible patients were considered in the evaluation of adverse events.
 
Arm/Group Title Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With VI
Hide Arm/Group Description

Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.

Dactinomycin: Given IV

Cyclophosphamide: Given IV

Vincristine Sulfate: Given IV

Radiation Therapy: Undergo radiotherapy

Laboratory Biomarker Analysis: Correlative studies

Questionnaire Administration: Ancillary studies

Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.

Irinotecan Hydrochloride: Given IV

Dactinomycin: Given IV

Cyclophosphamide: Given IV

Vincristine Sulfate: Given IV

Radiation Therapy: Undergo radiotherapy

Laboratory Biomarker Analysis: Correlative studies

Questionnaire Administration: Ancillary studies

All-Cause Mortality
Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With VI
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With VI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/222 (1.80%)      11/226 (4.87%)    
Blood and lymphatic system disorders     
Anemia  1/222 (0.45%)  1 0/226 (0.00%)  0
Gastrointestinal disorders     
Ascites  1/222 (0.45%)  1 0/226 (0.00%)  0
Esophagitis  0/222 (0.00%)  0 1/226 (0.44%)  1
Gastritis  0/222 (0.00%)  0 1/226 (0.44%)  1
Gastrointestinal disorders - Other, specify  0/222 (0.00%)  0 1/226 (0.44%)  1
Mucositis oral  0/222 (0.00%)  0 2/226 (0.88%)  2
Oral pain  0/222 (0.00%)  0 1/226 (0.44%)  1
General disorders     
Death NOS  0/222 (0.00%)  0 2/226 (0.88%)  2
Hepatobiliary disorders     
Hepatic pain  1/222 (0.45%)  1 0/226 (0.00%)  0
Hepatobiliary disorders - Other, specify  1/222 (0.45%)  1 0/226 (0.00%)  0
Infections and infestations     
Sepsis  0/222 (0.00%)  0 1/226 (0.44%)  1
Injury, poisoning and procedural complications     
Radiation recall reaction (dermatologic)  0/222 (0.00%)  0 1/226 (0.44%)  1
Tracheal obstruction  0/222 (0.00%)  0 1/226 (0.44%)  1
Investigations     
Alanine aminotransferase increased  1/222 (0.45%)  1 0/226 (0.00%)  0
Aspartate aminotransferase increased  1/222 (0.45%)  1 0/226 (0.00%)  0
Blood bilirubin increased  1/222 (0.45%)  1 0/226 (0.00%)  0
Lymphocyte count decreased  0/222 (0.00%)  0 1/226 (0.44%)  1
Platelet count decreased  1/222 (0.45%)  1 0/226 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalemia  0/222 (0.00%)  0 1/226 (0.44%)  1
Hyponatremia  1/222 (0.45%)  1 0/226 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  0/222 (0.00%)  0 1/226 (0.44%)  1
Treatment related secondary malignancy  0/222 (0.00%)  0 1/226 (0.44%)  1
Nervous system disorders     
Encephalopathy  0/222 (0.00%)  0 1/226 (0.44%)  1
Intracranial hemorrhage  0/222 (0.00%)  0 1/226 (0.44%)  1
Nervous system disorders - Other, specify  3/222 (1.35%)  3 0/226 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pharyngeal mucositis  0/222 (0.00%)  0 1/226 (0.44%)  1
Pharyngolaryngeal pain  0/222 (0.00%)  0 1/226 (0.44%)  1
Pneumothorax  0/222 (0.00%)  0 1/226 (0.44%)  1
1
Term from vocabulary, CTCv4
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vincristine, Dactinomycin, Cyclophosphamide (VAC) VAC Alternating With VI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   209/222 (94.14%)      213/226 (94.25%)    
Blood and lymphatic system disorders     
Anemia  102/222 (45.95%)  183 57/226 (25.22%)  89
Febrile neutropenia  62/222 (27.93%)  86 46/226 (20.35%)  57
Cardiac disorders     
Cardiac arrest  0/222 (0.00%)  0 1/226 (0.44%)  1
Ventricular fibrillation  0/222 (0.00%)  0 1/226 (0.44%)  1
Ear and labyrinth disorders     
External ear inflammation  1/222 (0.45%)  1 0/226 (0.00%)  0
Hearing impaired  1/222 (0.45%)  2 0/226 (0.00%)  0
Eye disorders     
Extraocular muscle paresis  1/222 (0.45%)  1 0/226 (0.00%)  0
Eye disorders - Other, specify  0/222 (0.00%)  0 1/226 (0.44%)  1
Eyelid function disorder  1/222 (0.45%)  1 0/226 (0.00%)  0
Optic nerve disorder  0/222 (0.00%)  0 2/226 (0.88%)  4
Watering eyes  0/222 (0.00%)  0 1/226 (0.44%)  1
Gastrointestinal disorders     
Abdominal distension  0/222 (0.00%)  0 2/226 (0.88%)  2
Abdominal pain  9/222 (4.05%)  11 12/226 (5.31%)  14
Anal mucositis  0/222 (0.00%)  0 1/226 (0.44%)  1
Anal pain  1/222 (0.45%)  1 0/226 (0.00%)  0
Colitis  1/222 (0.45%)  1 4/226 (1.77%)  4
Constipation  4/222 (1.80%)  5 6/226 (2.65%)  6
Diarrhea  14/222 (6.31%)  17 51/226 (22.57%)  63
Dry mouth  0/222 (0.00%)  0 2/226 (0.88%)  3
Dysphagia  3/222 (1.35%)  3 6/226 (2.65%)  6
Enterocolitis  0/222 (0.00%)  0 1/226 (0.44%)  1
Esophagitis  0/222 (0.00%)  0 3/226 (1.33%)  4
Gastritis  2/222 (0.90%)  2 1/226 (0.44%)  1
Gastrointestinal disorders - Other, specify  1/222 (0.45%)  1 2/226 (0.88%)  2
Ileus  1/222 (0.45%)  1 6/226 (2.65%)  6
Mucositis oral  25/222 (11.26%)  31 46/226 (20.35%)  48
Nausea  8/222 (3.60%)  10 26/226 (11.50%)  41
Oral pain  3/222 (1.35%)  4 7/226 (3.10%)  7
Rectal pain  1/222 (0.45%)  1 0/226 (0.00%)  0
Stomach pain  0/222 (0.00%)  0 2/226 (0.88%)  2
Typhlitis  1/222 (0.45%)  1 3/226 (1.33%)  3
Vomiting  16/222 (7.21%)  17 28/226 (12.39%)  37
General disorders     
Edema trunk  1/222 (0.45%)  1 1/226 (0.44%)  1
Facial pain  1/222 (0.45%)  1 3/226 (1.33%)  3
Fatigue  0/222 (0.00%)  0 5/226 (2.21%)  5
Fever  9/222 (4.05%)  10 11/226 (4.87%)  11
General disorders and administration site conditions - Other, specify  1/222 (0.45%)  1 0/226 (0.00%)  0
Pain  4/222 (1.80%)  9 9/226 (3.98%)  12
Hepatobiliary disorders     
Cholecystitis  1/222 (0.45%)  1 0/226 (0.00%)  0
Hepatic pain  1/222 (0.45%)  1 0/226 (0.00%)  0
Portal hypertension  2/222 (0.90%)  2 0/226 (0.00%)  0
Immune system disorders     
Anaphylaxis  4/222 (1.80%)  4 1/226 (0.44%)  1
Infections and infestations     
Abdominal infection  0/222 (0.00%)  0 2/226 (0.88%)  2
Anorectal infection  0/222 (0.00%)  0 1/226 (0.44%)  2
Appendicitis  1/222 (0.45%)  1 0/226 (0.00%)  0
Bladder infection  2/222 (0.90%)  2 3/226 (1.33%)  3
Bronchial infection  0/222 (0.00%)  0 1/226 (0.44%)  1
Catheter related infection  6/222 (2.70%)  8 13/226 (5.75%)  15
Conjunctivitis infective  0/222 (0.00%)  0 1/226 (0.44%)  1
Device related infection  2/222 (0.90%)  2 4/226 (1.77%)  5
Enterocolitis infectious  5/222 (2.25%)  6 10/226 (4.42%)  10
Esophageal infection  0/222 (0.00%)  0 1/226 (0.44%)  1
Eye infection  0/222 (0.00%)  0 3/226 (1.33%)  3
Gum infection  2/222 (0.90%)  2 0/226 (0.00%)  0
Infections and infestations - Other, specify  40/222 (18.02%)  60 37/226 (16.37%)  56
Lung infection  0/222 (0.00%)  0 4/226 (1.77%)  4
Otitis media  0/222 (0.00%)  0 1/226 (0.44%)  1
Paronychia  0/222 (0.00%)  0 1/226 (0.44%)  1
Pleural infection  1/222 (0.45%)  1 0/226 (0.00%)  0
Sepsis  1/222 (0.45%)  1 1/226 (0.44%)  1
Sinusitis  3/222 (1.35%)  3 1/226 (0.44%)  1
Skin infection  5/222 (2.25%)  5 7/226 (3.10%)  7
Small intestine infection  1/222 (0.45%)  1 0/226 (0.00%)  0
Soft tissue infection  1/222 (0.45%)  1 0/226 (0.00%)  0
Upper respiratory infection  3/222 (1.35%)  4 4/226 (1.77%)  4
Urethral infection  1/222 (0.45%)  1 0/226 (0.00%)  0
Urinary tract infection  10/222 (4.50%)  11 8/226 (3.54%)  13
Vaginal infection  0/222 (0.00%)  0 1/226 (0.44%)  1
Vulval infection  1/222 (0.45%)  1 0/226 (0.00%)  0
Wound infection  3/222 (1.35%)  3 1/226 (0.44%)  1
Injury, poisoning and procedural complications     
Dermatitis radiation  6/222 (2.70%)  6 2/226 (0.88%)  2
Fracture  1/222 (0.45%)  1 0/226 (0.00%)  0
Radiation recall reaction (dermatologic)  1/222 (0.45%)  1 3/226 (1.33%)  3
Seroma  0/222 (0.00%)  0 1/226 (0.44%)  1
Vascular access complication  1/222 (0.45%)  1 2/226 (0.88%)  2
Wound complication  0/222 (0.00%)  0 1/226 (0.44%)  1
Wound dehiscence  0/222 (0.00%)  0 2/226 (0.88%)  2
Investigations     
Activated partial thromboplastin time prolonged  1/222 (0.45%)  1 0/226 (0.00%)  0
Alanine aminotransferase increased  19/222 (8.56%)  21 16/226 (7.08%)  22
Alkaline phosphatase increased  1/222 (0.45%)  1 0/226 (0.00%)  0
Aspartate aminotransferase increased  11/222 (4.95%)  13 7/226 (3.10%)  8
Blood bilirubin increased  3/222 (1.35%)  3 1/226 (0.44%)  1
GGT increased  2/222 (0.90%)  2 1/226 (0.44%)  1
Hemoglobin increased  1/222 (0.45%)  1 0/226 (0.00%)  0
Investigations - Other, specify  1/222 (0.45%)  1 0/226 (0.00%)  0
Lipase increased  1/222 (0.45%)  1 2/226 (0.88%)  2
Lymphocyte count decreased  48/222 (21.62%)  144 57/226 (25.22%)  148
Neutrophil count decreased  179/222 (80.63%)  484 177/226 (78.32%)  436
Platelet count decreased  94/222 (42.34%)  164 37/226 (16.37%)  52
Serum amylase increased  1/222 (0.45%)  1 0/226 (0.00%)  0
Weight gain  0/222 (0.00%)  0 2/226 (0.88%)  3
Weight loss  13/222 (5.86%)  14 23/226 (10.18%)  32
White blood cell decreased  100/222 (45.05%)  235 96/226 (42.48%)  219
Metabolism and nutrition disorders     
Anorexia  24/222 (10.81%)  30 35/226 (15.49%)  42
Dehydration  10/222 (4.50%)  10 23/226 (10.18%)  26
Hyperglycemia  4/222 (1.80%)  4 11/226 (4.87%)  14
Hyperkalemia  1/222 (0.45%)  1 3/226 (1.33%)  3
Hypermagnesemia  1/222 (0.45%)  1 0/226 (0.00%)  0
Hypernatremia  0/222 (0.00%)  0 2/226 (0.88%)  2
Hypoalbuminemia  1/222 (0.45%)  1 1/226 (0.44%)  1
Hypocalcemia  3/222 (1.35%)  3 4/226 (1.77%)  5
Hypoglycemia  1/222 (0.45%)  1 1/226 (0.44%)  1
Hypokalemia  24/222 (10.81%)  25 34/226 (15.04%)  40
Hyponatremia  14/222 (6.31%)  16 15/226 (6.64%)  15
Hypophosphatemia  7/222 (3.15%)  8 3/226 (1.33%)  4
Metabolism and nutrition disorders - Other, specify  0/222 (0.00%)  0 1/226 (0.44%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  0/222 (0.00%)  0 1/226 (0.44%)  1
Back pain  4/222 (1.80%)  4 0/226 (0.00%)  0
Bone pain  1/222 (0.45%)  1 0/226 (0.00%)  0
Muscle weakness lower limb  2/222 (0.90%)  4 1/226 (0.44%)  1
Muscle weakness upper limb  0/222 (0.00%)  0 1/226 (0.44%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1/222 (0.45%)  1 0/226 (0.00%)  0
Neck pain  0/222 (0.00%)  0 1/226 (0.44%)  1
Pain in extremity  3/222 (1.35%)  3 2/226 (0.88%)  2
Trismus  0/222 (0.00%)  0 1/226 (0.44%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1/222 (0.45%)  1 1/226 (0.44%)  1
Nervous system disorders     
Abducens nerve disorder  0/222 (0.00%)  0 1/226 (0.44%)  1
Aphonia  1/222 (0.45%)  1 0/226 (0.00%)  0
Ataxia  0/222 (0.00%)  0 3/226 (1.33%)  3
Cognitive disturbance  1/222 (0.45%)  1 0/226 (0.00%)  0
Depressed level of consciousness  0/222 (0.00%)  0 1/226 (0.44%)  1
Dizziness  0/222 (0.00%)  0 2/226 (0.88%)  2
Dysesthesia  0/222 (0.00%)  0 1/226 (0.44%)  1
Encephalopathy  0/222 (0.00%)  0 2/226 (0.88%)  2
Facial nerve disorder  0/222 (0.00%)  0 1/226 (0.44%)  1
Headache  4/222 (1.80%)  6 3/226 (1.33%)  3
Hypoglossal nerve disorder  0/222 (0.00%)  0 1/226 (0.44%)  1
Nervous system disorders - Other, specify  1/222 (0.45%)  1 0/226 (0.00%)  0
Neuralgia  1/222 (0.45%)  1 2/226 (0.88%)  2
Nystagmus  0/222 (0.00%)  0 1/226 (0.44%)  1
Oculomotor nerve disorder  0/222 (0.00%)  0 2/226 (0.88%)  4
Peripheral motor neuropathy  29/222 (13.06%)  38 26/226 (11.50%)  44
Peripheral sensory neuropathy  16/222 (7.21%)  21 13/226 (5.75%)  19
Recurrent laryngeal nerve palsy  1/222 (0.45%)  1 0/226 (0.00%)  0
Sinus pain  0/222 (0.00%)  0 1/226 (0.44%)  1
Syncope  2/222 (0.90%)  2 2/226 (0.88%)  3
Vagus nerve disorder  0/222 (0.00%)  0 1/226 (0.44%)  1
Vasovagal reaction  0/222 (0.00%)  0 1/226 (0.44%)  1
Psychiatric disorders     
Confusion  0/222 (0.00%)  0 1/226 (0.44%)  1
Depression  0/222 (0.00%)  0 3/226 (1.33%)  3
Insomnia  0/222 (0.00%)  0 1/226 (0.44%)  1
Psychiatric disorders - Other, specify  0/222 (0.00%)  0 1/226 (0.44%)  1
Renal and urinary disorders     
Bladder spasm  1/222 (0.45%)  1 2/226 (0.88%)  4
Cystitis noninfective  1/222 (0.45%)  1 0/226 (0.00%)  0
Hematuria  3/222 (1.35%)  4 1/226 (0.44%)  1
Renal and urinary disorders - Other, specify  0/222 (0.00%)  0 2/226 (0.88%)  2
Urinary retention  0/222 (0.00%)  0 1/226 (0.44%)  1
Urinary tract obstruction  1/222 (0.45%)  1 0/226 (0.00%)  0
Reproductive system and breast disorders     
Penile pain  1/222 (0.45%)  1 0/226 (0.00%)  0
Vaginal pain  0/222 (0.00%)  0 1/226 (0.44%)  1
Respiratory, thoracic and mediastinal disorders     
Atelectasis  2/222 (0.90%)  2 0/226 (0.00%)  0
Cough  1/222 (0.45%)  1 1/226 (0.44%)  1
Dyspnea  1/222 (0.45%)  1 1/226 (0.44%)  1
Epistaxis  1/222 (0.45%)  1 1/226 (0.44%)  1
Hypoxia  1/222 (0.45%)  1 6/226 (2.65%)  7
Laryngeal edema  1/222 (0.45%)  1 2/226 (0.88%)  2
Laryngeal mucositis  1/222 (0.45%)  1 0/226 (0.00%)  0
Pharyngeal mucositis  3/222 (1.35%)  3 4/226 (1.77%)  4
Pharyngolaryngeal pain  2/222 (0.90%)  2 1/226 (0.44%)  1
Pleural effusion  1/222 (0.45%)  1 1/226 (0.44%)  1
Respiratory failure  1/222 (0.45%)  1 0/226 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  0/222 (0.00%)  0 1/226 (0.44%)  1
Stridor  0/222 (0.00%)  0 1/226 (0.44%)  1
Tracheal mucositis  0/222 (0.00%)  0 1/226 (0.44%)  1
Voice alteration  1/222 (0.45%)  1 0/226 (0.00%)  0
Wheezing  1/222 (0.45%)  1 1/226 (0.44%)  1
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1/222 (0.45%)  1 2/226 (0.88%)  2
Skin and subcutaneous tissue disorders - Other, specify  0/222 (0.00%)  0 1/226 (0.44%)  1
Urticaria  1/222 (0.45%)  1 0/226 (0.00%)  0
Vascular disorders     
Hypertension  0/222 (0.00%)  0 3/226 (1.33%)  5
Hypotension  0/222 (0.00%)  0 1/226 (0.44%)  1
Thromboembolic event  1/222 (0.45%)  1 3/226 (1.33%)  3
Vascular disorders - Other, specify  1/222 (0.45%)  1 0/226 (0.00%)  0
1
Term from vocabulary, CTCv4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00354835    
Other Study ID Numbers: ARST0531
NCI-2009-00427 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST0531 ( Other Identifier: Children's Oncology Group )
CDR0000487560 ( Other Identifier: ClinicalTrials.gov )
ARST0531 ( Other Identifier: Children's Oncology Group )
ARST0531 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
U10CA180886 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2006
First Posted: July 20, 2006
Results First Submitted: July 8, 2016
Results First Posted: July 25, 2017
Last Update Posted: October 27, 2020