Trial Outcomes & Findings for Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma (NCT NCT00346164)
NCT ID: NCT00346164
Last Updated: 2022-04-28
Results Overview
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
588 participants
Primary outcome timeframe
5 years
Results posted on
2022-04-28
Participant Flow
Participant milestones
| Measure |
Arm A: No Adjuvant Treatment
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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 Study
STARTED
|
222
|
21
|
122
|
223
|
|
Overall Study
COMPLETED
|
205
|
14
|
96
|
117
|
|
Overall Study
NOT COMPLETED
|
17
|
7
|
26
|
106
|
Reasons for withdrawal
| Measure |
Arm A: No Adjuvant Treatment
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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 Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
7
|
25
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
27
|
|
Overall Study
Protocol Violation
|
6
|
2
|
10
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
|
Overall Study
Ineligible
|
11
|
2
|
2
|
23
|
|
Overall Study
Refusal of further protocol therapy
|
0
|
1
|
3
|
15
|
|
Overall Study
Inability to start week 16 tx on time
|
0
|
0
|
0
|
11
|
Baseline Characteristics
Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Arm A: No Adjuvant Treatment
n=222 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=21 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
n=122 Participants
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
n=223 Participants
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
n=588 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
138.87 Months
STANDARD_DEVIATION 60.88 • n=5 Participants
|
142.58 Months
STANDARD_DEVIATION 59.46 • n=7 Participants
|
155.14 Months
STANDARD_DEVIATION 69.20 • n=5 Participants
|
171.31 Months
STANDARD_DEVIATION 68.90 • n=4 Participants
|
154.68 Months
STANDARD_DEVIATION 67.10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
313 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
275 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
185 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
477 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
169 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
412 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Ineligible patients are excluded as well as patients who were treated on the incorrect arm.
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=205 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=17 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
n=110 Participants
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
n=196 Participants
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
|
|---|---|---|---|---|
|
Probability for Event Free Survival.
|
0.8984 Probability of EFS at 5 years
Interval 0.8395 to 0.9572
|
0.7647 Probability of EFS at 5 years
Interval 0.5348 to 0.9946
|
0.6079 Probability of EFS at 5 years
Interval 0.4818 to 0.7341
|
0.4873 Probability of EFS at 5 years
Interval 0.3951 to 0.5796
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Excluding ineligible patients and patients not treated based on the protocol.
Percentage of Arm D patients experiencing grade 4+ adverse events.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=196 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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
|
|---|---|---|---|---|
|
Toxicity Rate
|
3.06 percentage of participants
Interval 0.65 to 5.47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Only Arm D patients were evaluated for imaging response at week 13 after surgery. Ineligible and inevaluable Arm D patients were excluded.
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.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=142 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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
|
|---|---|---|---|---|
|
Complete or Partial Response Rate
|
33.1 percentage of patients
Interval 25.36 to 40.84
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Only Arm D patients were evaluated at week 13 for percent tumor necrosis. Ineligible and inevaluable Arm D patients were excluded.
Percent tumor necrosis by pathology review.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=129 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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
|
|---|---|---|---|---|
|
Percent Tumor Necrosis
|
59.4 percentage of tumor necrosis
Standard Deviation 38.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=425 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=69 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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
|
|---|---|---|---|---|
|
Event Free Survival Probability Disease Extent
|
0.7758 Probability
Interval 0.7202 to 0.8313
|
0.1960 Probability
Interval 0.0742 to 0.3178
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Probability of no relapse, secondary malignancy or death after 5 years since enrollment
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=60 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=79 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
n=355 Participants
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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
|
|---|---|---|---|---|
|
Event Free Survival Probability Histologic Grade
|
0.9636 Probability
Interval 0.8943 to 1.0
|
0.8505 Probability
Interval 0.7382 to 0.9627
|
0.6136 Probability
Interval 0.5442 to 0.6831
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Probability of survival after 5 years since enrollment.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=425 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=69 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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 Survival Probability Disease Extent
|
0.8752 Probability
Interval 0.8313 to 0.919
|
0.3153 Probability
Interval 0.1677 to 0.4629
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Probability of survival after 5 years since enrollment.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=163 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=247 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
n=84 Participants
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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 Survival Probability Extent of Resection of the Primary Tumor
|
0.5975 Probability
Interval 0.4913 to 0.7036
|
0.9353 Probability
Interval 0.8923 to 0.9782
|
0.7764 Probability
Interval 0.6565 to 0.8963
|
—
|
SECONDARY outcome
Timeframe: Up to 10 yearsPopulation: 94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Percent of patients who had distant metastasis.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=425 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=69 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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
|
|---|---|---|---|---|
|
Incidence of Distant Metastasis
|
10.59 Percentage of participants
Interval 7.66 to 13.51
|
60.87 Percentage of participants
Interval 49.35 to 72.39
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 10 yearsPopulation: 94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
Percent of patients who had distant metastasis.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=60 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=79 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
n=355 Participants
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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
|
|---|---|---|---|---|
|
Incidence of Distant Metastasis
|
0.00 Percentage of participants
Interval 0.0 to
Dispersion can't be estimated because no participants with histological grade 1 had a distant metastasis.
|
5.06 Percentage of participants
Interval 0.23 to 9.9
|
23.38 Percentage of participants
Interval 18.98 to 27.78
|
—
|
SECONDARY outcome
Timeframe: At diagnosisPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At DiagnosisPopulation: 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.
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.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=45 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=71 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
n=278 Participants
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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
|
|---|---|---|---|---|
|
Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers
Histologic grade 1 by central pathology reviewers
|
38 Participants
|
5 Participants
|
1 Participants
|
—
|
|
Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers
Histologic grade 2 by central pathology reviewers
|
4 Participants
|
56 Participants
|
9 Participants
|
—
|
|
Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers
Histologic grade 3 by central pathology reviewers
|
3 Participants
|
10 Participants
|
268 Participants
|
—
|
SECONDARY outcome
Timeframe: At diagnosisPopulation: 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.
POG and FNCLCC grades were determined by pathologists based on published standards. A higher grade is associated with a more severe disease.
Outcome measures
| Measure |
Arm A: No Adjuvant Treatment
n=79 Participants
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=222 Participants
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
n=241 Participants
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
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
|
|---|---|---|---|---|
|
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
Histologic grade 1 by POG
|
46 Participants
|
8 Participants
|
1 Participants
|
—
|
|
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
Histologic grade 2 by POG
|
24 Participants
|
69 Participants
|
0 Participants
|
—
|
|
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
Histologic grade 3 by POG
|
9 Participants
|
145 Participants
|
240 Participants
|
—
|
Adverse Events
Arm A: No Adjuvant Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B: Low Risk; Adjuvant Radiotherapy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: No Adjuvant Treatment
n=205 participants at risk
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=17 participants at risk
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
n=110 participants at risk
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
n=196 participants at risk
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
|
|---|---|---|---|---|
|
General disorders
Death NOS
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
5.9%
1/17 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/196
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.91%
1/110 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/196
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
Other adverse events
| Measure |
Arm A: No Adjuvant Treatment
n=205 participants at risk
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
|
Arm B: Low Risk; Adjuvant Radiotherapy
n=17 participants at risk
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
|
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
n=110 participants at risk
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
|
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
n=196 participants at risk
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
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Vascular disorders
Hypotension
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.91%
1/110 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Nervous system disorders
Seizure
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.91%
1/110 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/205
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/17
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.00%
0/110
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
0.51%
1/196 • Number of events 1
Ineligible patients and patients who were not treated based on the protocol were excluded from AE reporting (both serious and other).
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER