Trial · NCT00346164

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

NCT00346164, Phase 3, Completed, Children's Oncology Group; results first posted 2017-10-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma. Trials, record NCT00346164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00346164

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
NCT number: NCT00346164
Status: Completed
Phases: Phase 3
Enrollment: 588 participants, actual
Lead sponsor: Children's Oncology Group
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: doxorubicin hydrochloride, clinical observation, therapeutic conventional surgery, 3-dimensional conformal radiation therapy, ifosfamide
First posted: 2006-06-29
Last updated: 2022-04-28
Results first posted: 2017-10-06

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Probability for Event Free Survival.	5 years	Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Secondary	Toxicity Rate	13 weeks	Percentage of Arm D patients experiencing grade 4+ adverse events.
Secondary	Complete or Partial Response Rate	13 weeks	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.
Secondary	Percent Tumor Necrosis	13 weeks	Percent tumor necrosis by pathology review.
Secondary	Event Free Survival Probability Disease Extent	5 years	Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Secondary	Event Free Survival Probability Histologic Grade	5 years	Probability of no relapse, secondary malignancy or death after 5 years since enrollment
Secondary	Overall Survival Probability Disease Extent	5 years	Probability of survival after 5 years since enrollment.
Secondary	Overall Survival Probability Extent of Resection of the Primary Tumor	5 years	Probability of survival after 5 years since enrollment.
Secondary	Incidence of Distant Metastasis	Up to 10 years	Percent of patients who had distant metastasis.
Secondary	Genetic and Gene Expression Profiles	At diagnosis	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.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Probability for Event Free Survival.	5 years	Ineligible patients are excluded as well as patients who were treated on the incorrect arm.	Probability of EFS at 5 years	NUMBER
SECONDARY	Toxicity Rate	13 weeks	Excluding ineligible patients and patients not treated based on the protocol.	percentage of participants	NUMBER
SECONDARY	Complete or Partial Response Rate	13 weeks	Only Arm D patients were evaluated for imaging response at week 13 after surgery. Ineligible and inevaluable Arm D patients were excluded.	percentage of patients	NUMBER
SECONDARY	Percent Tumor Necrosis	13 weeks	Only Arm D patients were evaluated at week 13 for percent tumor necrosis. Ineligible and inevaluable Arm D patients were excluded.	percentage of tumor necrosis	MEAN
SECONDARY	Event Free Survival Probability Disease Extent	5 years	94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.	Probability	NUMBER
SECONDARY	Event Free Survival Probability Histologic Grade	5 years	94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.	Probability	NUMBER
SECONDARY	Overall Survival Probability Disease Extent	5 years	94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.	Probability	NUMBER
SECONDARY	Overall Survival Probability Extent of Resection of the Primary Tumor	5 years	94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.	Probability	NUMBER
SECONDARY	Incidence of Distant Metastasis	Up to 10 years	94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.	Percentage of participants	NUMBER
SECONDARY	Incidence of Distant Metastasis	Up to 10 years	94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.	Percentage of participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Probability for Event Free Survival.	Arm A: No Adjuvant Treatment	0.8984	95% Confidence Interval 0.8395 to 0.9572	Probability of EFS at 5 years
Probability for Event Free Survival.	Arm B: Low Risk; Adjuvant Radiotherapy	0.7647	95% Confidence Interval 0.5348 to 0.9946	Probability of EFS at 5 years
Probability for Event Free Survival.	Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy	0.6079	95% Confidence Interval 0.4818 to 0.7341	Probability of EFS at 5 years
Probability for Event Free Survival.	Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy	0.4873	95% Confidence Interval 0.3951 to 0.5796	Probability of EFS at 5 years
Toxicity Rate	Arm D	3.06	95% Confidence Interval 0.65 to 5.47	percentage of participants
Complete or Partial Response Rate	Arm D	33.1	95% Confidence Interval 25.36 to 40.84	percentage of patients
Percent Tumor Necrosis	Arm D	59.4	Standard Deviation 38.5	percentage of tumor necrosis
Event Free Survival Probability Disease Extent	Non-metastatic	0.7758	95% Confidence Interval 0.7202 to 0.8313	Probability
Event Free Survival Probability Disease Extent	Metastatic	0.1960	95% Confidence Interval 0.0742 to 0.3178	Probability
Event Free Survival Probability Histologic Grade	Histologic Grade 1	0.9636	95% Confidence Interval 0.8943 to 1.0000	Probability

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: No Adjuvant Treatment	222
Overall Study	STARTED	Arm B: Low Risk; Adjuvant Radiotherapy	21
Overall Study	STARTED	Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy	122
Overall Study	STARTED	Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy	223
Overall Study	COMPLETED	Arm A: No Adjuvant Treatment	205
Overall Study	COMPLETED	Arm B: Low Risk; Adjuvant Radiotherapy	14
Overall Study	COMPLETED	Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy	96
Overall Study	COMPLETED	Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy	117
Overall Study	NOT COMPLETED	Arm A: No Adjuvant Treatment	17
Overall Study	NOT COMPLETED	Arm B: Low Risk; Adjuvant Radiotherapy	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events72

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cardiac disorders - Other, specify	Cardiac disorders	Arm A: No Adjuvant Treatment	0	205	0
other	Cardiac disorders - Other, specify	Cardiac disorders	Arm B: Low Risk; Adjuvant Radiotherapy	0	17	0
other	Cardiac disorders - Other, specify	Cardiac disorders	Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy	0	110	0
other	Cardiac disorders - Other, specify	Cardiac disorders	Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy	1	196	1
other	Dermatitis radiation	Injury, poisoning and procedural complications	Arm A: No Adjuvant Treatment	0	205	0
other	Dermatitis radiation	Injury, poisoning and procedural complications	Arm B: Low Risk; Adjuvant Radiotherapy	0	17	0
other	Dermatitis radiation	Injury, poisoning and procedural complications	Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy	0	110	0
other	Dermatitis radiation	Injury, poisoning and procedural complications	Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy	1	196	1
other	Diarrhea	Gastrointestinal disorders	Arm A: No Adjuvant Treatment	0	205	0
other	Diarrhea	Gastrointestinal disorders	Arm B: Low Risk; Adjuvant Radiotherapy	0	17	0

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: No Adjuvant Treatment
Total, all-cause mortality	Arm B: Low Risk; Adjuvant Radiotherapy
Total, all-cause mortality	Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
Total, all-cause mortality	Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
Total, other adverse events	Arm A: No Adjuvant Treatment	0	205
Total, other adverse events	Arm B: Low Risk; Adjuvant Radiotherapy	0	17
Total, other adverse events	Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy	2	110
Total, other adverse events	Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy	7	196
Total, serious adverse events	Arm A: No Adjuvant Treatment	0	205
Total, serious adverse events	Arm B: Low Risk; Adjuvant Radiotherapy	1	17

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28391003	DERIVED	PubMed
30954717	DERIVED	PubMed
31786124	DERIVED	PubMed
33548339	DERIVED	PubMed
34623899	DERIVED	PubMed
36566574	DERIVED	PubMed
38757485	DERIVED	PubMed
41386267	DERIVED	PubMed
42949735	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00346164

GET https://conductscience.org/api/trials/v1/NCT00346164/results?page=2

API reference For AI assistants