ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 66 for:    Sarcoma | "Dermatofibroma"

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

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: NCT00346164
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Alveolar Soft-part Sarcoma
Adult Angiosarcoma
Adult Epithelioid Sarcoma
Adult Extraskeletal Chondrosarcoma
Adult Extraskeletal Osteosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Malignant Fibrous Histiocytoma
Adult Malignant Hemangiopericytoma
Adult Malignant Mesenchymoma
Adult Neurofibrosarcoma
Adult Synovial Sarcoma
Childhood Alveolar Soft-part Sarcoma
Childhood Angiosarcoma
Childhood Epithelioid Sarcoma
Childhood Fibrosarcoma
Childhood Leiomyosarcoma
Childhood Liposarcoma
Childhood Malignant Mesenchymoma
Childhood Neurofibrosarcoma
Childhood Synovial Sarcoma
Dermatofibrosarcoma Protuberans
Metastatic Childhood Soft Tissue Sarcoma
Nonmetastatic Childhood Soft Tissue Sarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions Drug: doxorubicin hydrochloride
Other: clinical observation
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Drug: ifosfamide
Enrollment 588
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: No Adjuvant Treatment Arm B: Low Risk; Adjuvant Radiotherapy Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
Hide Arm/Group Description

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

Period Title: Overall Study
Started 222 21 122 223
Completed 205 14 96 117
Not Completed 17 7 26 106
Reason Not Completed
Adverse Event             0             0             0             1
Lack of Efficacy             0             1             7             25
Physician Decision             0             1             2             27
Protocol Violation             6             2             10             4
Withdrawal by Subject             0             0             2             0
Ineligible             11             2             2             23
Refusal of further protocol therapy             0             1             3             15
Inability to start week 16 tx on time             0             0             0             11
Arm/Group Title Arm A: No Adjuvant Treatment Arm B: Low Risk; Adjuvant Radiotherapy Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy Total
Hide Arm/Group Description

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 222 21 122 223 588
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 222 participants 21 participants 122 participants 223 participants 588 participants
138.87  (60.88) 142.58  (59.46) 155.14  (69.20) 171.31  (68.90) 154.68  (67.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 21 participants 122 participants 223 participants 588 participants
Female
124
  55.9%
9
  42.9%
60
  49.2%
120
  53.8%
313
  53.2%
Male
98
  44.1%
12
  57.1%
62
  50.8%
103
  46.2%
275
  46.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 21 participants 122 participants 223 participants 588 participants
Hispanic or Latino
29
  13.1%
1
   4.8%
22
  18.0%
38
  17.0%
90
  15.3%
Not Hispanic or Latino
185
  83.3%
19
  90.5%
95
  77.9%
178
  79.8%
477
  81.1%
Unknown or Not Reported
8
   3.6%
1
   4.8%
5
   4.1%
7
   3.1%
21
   3.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 21 participants 122 participants 223 participants 588 participants
American Indian or Alaska Native
1
   0.5%
0
   0.0%
2
   1.6%
3
   1.3%
6
   1.0%
Asian
7
   3.2%
1
   4.8%
2
   1.6%
8
   3.6%
18
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
1
   0.2%
Black or African American
23
  10.4%
2
   9.5%
21
  17.2%
43
  19.3%
89
  15.1%
White
169
  76.1%
16
  76.2%
90
  73.8%
137
  61.4%
412
  70.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
22
   9.9%
2
   9.5%
7
   5.7%
31
  13.9%
62
  10.5%
1.Primary Outcome
Title Probability for Event Free Survival.
Hide Description Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Ineligible patients are excluded as well as patients who were treated on the incorrect arm.
Arm/Group Title Arm A: No Adjuvant Treatment Arm B: Low Risk; Adjuvant Radiotherapy Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
Hide Arm/Group Description:

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

Overall Number of Participants Analyzed 205 17 110 196
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of EFS at 5 years
0.8984
(0.8395 to 0.9572)
0.7647
(0.5348 to 0.9946)
0.6079
(0.4818 to 0.7341)
0.4873
(0.3951 to 0.5796)
2.Secondary Outcome
Title Toxicity Rate
Hide Description Percentage of Arm D patients experiencing grade 4+ adverse events.
Time Frame 13 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Excluding ineligible patients and patients not treated based on the protocol.
Arm/Group Title Arm D
Hide Arm/Group Description:
Intermediate & High Risk; Neoadjuvant chemoradiotherapy
Overall Number of Participants Analyzed 196
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.06
(0.65 to 5.47)
3.Secondary Outcome
Title Complete or Partial Response Rate
Hide Description Tumor response by imaging. Complete Response (CR): Complete disappearance of the tumor. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Overall Response (OR)=CR+PR.
Time Frame 13 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only Arm D patients were evaluated for imaging response at week 13 after surgery. Ineligible and inevaluable Arm D patients were excluded.
Arm/Group Title Arm D
Hide Arm/Group Description:
Intermediate & High Risk; Neoadjuvant chemoradiotherapy
Overall Number of Participants Analyzed 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
33.1
(25.36 to 40.84)
4.Secondary Outcome
Title Percent Tumor Necrosis
Hide Description Percent tumor necrosis by pathology review.
Time Frame 13 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only Arm D patients were evaluated at week 13 for percent tumor necrosis. Ineligible and inevaluable Arm D patients were excluded.
Arm/Group Title Arm D
Hide Arm/Group Description:
Intermediate & High Risk; Neoadjuvant chemoradiotherapy
Overall Number of Participants Analyzed 129
Mean (Standard Deviation)
Unit of Measure: percentage of tumor necrosis
59.4  (38.5)
5.Secondary Outcome
Title Event Free Survival Probability Disease Extent
Hide Description Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Arm/Group Title Non-metastatic Metastatic
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 425 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.7758
(0.7202 to 0.8313)
0.1960
(0.0742 to 0.3178)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-metastatic, Metastatic
Comments The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
6.Secondary Outcome
Title Event Free Survival Probability Histologic Grade
Hide Description Probability of no relapse, secondary malignancy or death after 5 years since enrollment
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Arm/Group Title Histologic Grade 1 Histologic Grade 2 Histologic Grade 3
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 60 79 355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.9636
(0.8943 to 1.0000)
0.8505
(0.7382 to 0.9627)
0.6136
(0.5442 to 0.6831)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Histologic Grade 1, Histologic Grade 2, Histologic Grade 3
Comments The Cox proportional hazards model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
7.Secondary Outcome
Title Overall Survival Probability Disease Extent
Hide Description Probability of survival after 5 years since enrollment.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Arm/Group Title Non-metastatic Metastatic
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 425 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.8752
(0.8313 to 0.9190)
0.3153
(0.1677 to 0.4629)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-metastatic, Metastatic
Comments The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
8.Secondary Outcome
Title Overall Survival Probability Extent of Resection of the Primary Tumor
Hide Description Probability of survival after 5 years since enrollment.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Arm/Group Title Less Than Total Resection Negative Margins Positive Margins
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 163 247 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.5975
(0.4913 to 0.7036)
0.9353
(0.8923 to 0.9782)
0.7764
(0.6565 to 0.8963)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Less Than Total Resection, Negative Margins, Positive Margins
Comments The Cox proportional hazards model was used to evaluate prognostic impact of the resection extent of the primary tumor (less than total resection; margin -; margin +) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), disease extent (non-metastatic; metastatic), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and histologic (POG) grade.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0096
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
9.Secondary Outcome
Title Incidence of Distant Metastasis
Hide Description Percent of patients who had distant metastasis.
Time Frame Up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Arm/Group Title Non-metastatic Metastatic
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 425 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
10.59
(7.66 to 13.51)
60.87
(49.35 to 72.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-metastatic, Metastatic
Comments The logistic regression model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.
10.Secondary Outcome
Title Incidence of Distant Metastasis
Hide Description Percent of patients who had distant metastasis.
Time Frame Up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Arm/Group Title Histologic Grade 1 Histologic Grade 2 Histologic Grade 3
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 60 79 355
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.00 [1] 
(0.00 to NA)
5.06
(0.23 to 9.90)
23.38
(18.98 to 27.78)
[1]
Dispersion can’t be estimated because no participants with histological grade 1 had a distant metastasis.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Histologic Grade 1, Histologic Grade 2, Histologic Grade 3
Comments The logistic regression model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0228
Comments [Not Specified]
Method Regression, Logistic
Comments Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.
11.Secondary Outcome
Title Genetic and Gene Expression Profiles
Hide Description The tumors from patients registered on D9902 will be analyzed for genetic and gene expression profiles. The study will prospectively evaluate each tumor and confirm newly defined sarcoma diagnostic criteria based on cancer signatures in NRSTS.
Time Frame At diagnosis
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the tumors were analyzed for genetic and gene expression profiles. The analysis will not be completed. The time frame “At diagnosis” is the time frame for the gene expression profiles.
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers
Hide Description Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.
Time Frame At Diagnosis
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Ineligible patients, as well as patients without histologic grade determined by enrolling institution or central pathology reviewers were excluded. The OM evaluates the degree of agreement of two pathology grading reviews at diagnosis. The time frame “At diagnosis” reflects the OM.
Arm/Group Title Histologic Grade 1 by Enrolling Institution Histologic Grade 2 by Enrolling Institution Histologic Grade 3 by Enrolling Institution
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 45 71 278
Measure Type: Number
Unit of Measure: Participants
Histologic grade 1 by central pathology reviewers 38 5 1
Histologic grade 2 by central pathology reviewers 4 56 9
Histologic grade 3 by central pathology reviewers 3 10 268
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Histologic Grade 1 by Enrolling Institution, Histologic Grade 2 by Enrolling Institution, Histologic Grade 3 by Enrolling Institution
Comments Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kappa statistic
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.76 to 0.88
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Degree of Agreement in Histologic Grade Between Pediatric Oncology Group (POG) and Fédération Nationale Des Centres de Lutte Contre le Cancer (FNCLCC) Pathologic Grading Systems
Hide Description POG and FNCLCC grades were determined by pathologists based on published standards. A higher grade is associated with a more severe disease.
Time Frame At diagnosis
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Ineligible patients, as well as patients without histologic grade determined by POG or FNCLCC were excluded. The OM evaluates the degree of agreement of two pathology grading systems applied at diagnosis. The time frame “At diagnosis” reflects the OM.
Arm/Group Title Histologic Grade 1 by FNCLCC Histologic Grade 2 by FNCLCC Histologic Grade 3 by FNCLCC
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 79 222 241
Measure Type: Count of Participants
Unit of Measure: Participants
Histologic grade 1 by POG
46
  58.2%
8
   3.6%
1
   0.4%
Histologic grade 2 by POG
24
  30.4%
69
  31.1%
0
   0.0%
Histologic grade 3 by POG
9
  11.4%
145
  65.3%
240
  99.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Histologic Grade 1 by FNCLCC, Histologic Grade 2 by FNCLCC, Histologic Grade 3 by FNCLCC
Comments Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kappa statistic
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.36 to 0.48
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
 
Arm/Group Title Arm A: No Adjuvant Treatment Arm B: Low Risk; Adjuvant Radiotherapy Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
Hide Arm/Group Description

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.

doxorubicin hydrochloride: Given IV

clinical observation: Patients undergo observation

therapeutic conventional surgery: Patients undergo surgery

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

ifosfamide: Given IV

All-Cause Mortality
Arm A: No Adjuvant Treatment Arm B: Low Risk; Adjuvant Radiotherapy Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: No Adjuvant Treatment Arm B: Low Risk; Adjuvant Radiotherapy Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/205 (0.00%)      1/17 (5.88%)      1/110 (0.91%)      3/196 (1.53%)    
Gastrointestinal disorders         
Upper gastrointestinal hemorrhage  0/205 (0.00%)  0 0/17 (0.00%)  0 1/110 (0.91%)  1 0/196 (0.00%)  0
General disorders         
Death NOS  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Infections and infestations         
Infections and infestations - Other, specify  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Treatment related secondary malignancy  0/205 (0.00%)  0 1/17 (5.88%)  1 0/110 (0.00%)  0 0/196 (0.00%)  0
1
Term from vocabulary, CTCv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: No Adjuvant Treatment Arm B: Low Risk; Adjuvant Radiotherapy Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/205 (0.00%)      0/17 (0.00%)      2/110 (1.82%)      7/196 (3.57%)    
Cardiac disorders         
Cardiac disorders - Other, specify  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Pericardial effusion  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Gastrointestinal disorders         
Diarrhea  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
General disorders         
General disorders and administration site conditions - Other, specify  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Infections and infestations         
Hepatic infection  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Injury, poisoning and procedural complications         
Dermatitis radiation  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Wound dehiscence  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Metabolism and nutrition disorders         
Hypokalemia  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Nervous system disorders         
Encephalopathy  0/205 (0.00%)  0 0/17 (0.00%)  0 1/110 (0.91%)  1 1/196 (0.51%)  1
Seizure  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Skin and subcutaneous tissue disorders         
Skin ulceration  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
Vascular disorders         
Hypotension  0/205 (0.00%)  0 0/17 (0.00%)  0 1/110 (0.91%)  1 1/196 (0.51%)  1
Thromboembolic event  0/205 (0.00%)  0 0/17 (0.00%)  0 0/110 (0.00%)  0 1/196 (0.51%)  1
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
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00346164     History of Changes
Other Study ID Numbers: ARST0332
NCI-2009-00426 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST0332 ( Other Identifier: Children's Oncology Group )
CDR0000483702 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: June 28, 2006
First Posted: June 29, 2006
Results First Submitted: April 25, 2016
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017