Trial · NCT01231906

Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma

NCT01231906, Phase 3, Completed, Children's Oncology Group; results first posted 2021-05-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma. Trials, record NCT01231906. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01231906

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Trial

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

Title: Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
NCT number: NCT01231906
Status: Completed
Phases: Phase 3
Enrollment: 642 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Localized Extraskeletal Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissues
Interventions: Cyclophosphamide, Dexrazoxane, Doxorubicin Hydrochloride, Etoposide, Ifosfamide, Laboratory Biomarker Analysis, Topotecan Hydrochloride, Vincristine Sulfate
First posted: 2010-11-01
Last updated: 2026-01-23
Results first posted: 2021-05-04

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Event-Free Survival	5 years after enrollment	Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
Other	Overall Survival	5 years after enrollment	Time from study enrollment to death or last patient contact.
Other	Histological Response, in Terms of Event Free Survival After Local Control in Patients Who Received Local Control Therapy	At the end of INDUCTION THERAPY (84 days)	Percent of viable tumor in the resected tumor specimen after the patient receives 2 cycles of induction chemotherapy. Patients will be classified into groups according to: (1) good risk - less than 10% viable tumor in the resection specimen; and (2) standard risk - 10% or more viable tumor in the resection specimen. Patients who receive radiation therapy to the primary tumor prior to tumor resection or whose tumor is resected prior to the start of systemic therapy are not evaluable for this outcome measure.
Other	SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response at Enrollment	At study enrollment	Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median.
Other	SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response After Induction	At the end of INDUCTION THERAPY (84 days)	Patients will be classified into two groups according to SUVmax as: (1) study population median or greater; and (2) less than the study population median. Patients who receive radiation therapy to the primary tumor prior to the completion of 2 cycles of induction or who do not receive 2 cycles of induction chemotherapy are not evaluable for this outcome measure.
Other	Tumor Volume in Milliliters (ml) at Enrollment	At study enrollment	Patients will be classified into two groups: (1) tumor volume 200 ml or greater and (2) tumor volume less than 200 ml.
Other	Radiological Response of Soft Tissue Component of Mass by Radiological Evaluation at the End of Induction Chemotherapy	At the end of INDUCTION THERAPY (84 days)	Patients will be classified into two groups: (1) complete resolution of soft tissue mass; and (2) soft tissue mass present after induction chemotherapy. Patients who receive radiation therapy to the primary tumor prior to the completion of 2 cycles of induction, who do not receive 2 cycles of induction chemotherapy or who do not have soft tissue involvement detected at enrollment or at any time prior to the end of induction chemotherapy are not evaluable for this outcome measure.
Other	Type of Local Control Modality Used for Removal of Primary Tumor Site at Any Time up to the End of the First 6 Cycles of Consolidation Chemotherapy	126 days after enrollment	Patients will be categorized into the following groups: (1) surgery as the local control modality; (2) radiation therapy as the local control modality; (3) surgery and radiation therapy as the local control modality; and (4) no local control modality administered to the primary tumor site. Patients who do not complete induction chemotherapy will not be evaluable for this outcome measure.
Other	Occurrence of Grade 2 or Higher Musculoskeletal Event (ME), or Surgery Required to Treat a Complication of Local Therapy	132 days after enrollment	Any National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 ME of grade 2 or greater or ME of any grade where surgery is required to treat a complication of local therapy. Patients who do not complete induction chemotherapy or do not have any local control modality administered to the primary tumor site will not be evaluable for this outcome measure.
Other	Presence of Tumor at the Margin of Resection for Patients Who Have Surgery as the Only Local Control Modality	126 days after enrollment	Patients will be categorized into the following groups: (1) tumor present at the margin of resection; and (2) no tumor present at the margin of resection. Patients who are not classified as having surgery as the only local control modality will not be evaluable for this outcome measure.

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-Free Survival	5 years after enrollment	Only eligible patients are considered in the calculation of this outcome measure.	Percent Probability	NUMBER
OTHER_PRE_SPECIFIED	Overall Survival	5 years after enrollment
OTHER_PRE_SPECIFIED	Histological Response, in Terms of Event Free Survival After Local Control in Patients Who Received Local Control Therapy	At the end of INDUCTION THERAPY (84 days)
OTHER_PRE_SPECIFIED	SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response at Enrollment	At study enrollment
OTHER_PRE_SPECIFIED	SUVmax as Determined by Positron Emission Tomography (PET)-Determined Response After Induction	At the end of INDUCTION THERAPY (84 days)
OTHER_PRE_SPECIFIED	Tumor Volume in Milliliters (ml) at Enrollment	At study enrollment
OTHER_PRE_SPECIFIED	Radiological Response of Soft Tissue Component of Mass by Radiological Evaluation at the End of Induction Chemotherapy	At the end of INDUCTION THERAPY (84 days)
OTHER_PRE_SPECIFIED	Type of Local Control Modality Used for Removal of Primary Tumor Site at Any Time up to the End of the First 6 Cycles of Consolidation Chemotherapy	126 days after enrollment
OTHER_PRE_SPECIFIED	Occurrence of Grade 2 or Higher Musculoskeletal Event (ME), or Surgery Required to Treat a Complication of Local Therapy	132 days after enrollment
OTHER_PRE_SPECIFIED	Presence of Tumor at the Margin of Resection for Patients Who Have Surgery as the Only Local Control Modality	126 days after enrollment

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Event-Free Survival	Arm A (Combination Chemotherapy)		77.64	95% Confidence Interval 72.42 to 81.99	Percent Probability
Event-Free Survival	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)		78.79	95% Confidence Interval 73.70 to 83.01	Percent Probability

Source ClinicalTrials.gov

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A (Combination Chemotherapy)	319
Overall Study	STARTED	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	323
Overall Study	Received Therapy	Arm A (Combination Chemotherapy)	308
Overall Study	Received Therapy	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	318
Overall Study	COMPLETED	Arm A (Combination Chemotherapy)	198
Overall Study	COMPLETED	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	222
Overall Study	NOT COMPLETED	Arm A (Combination Chemotherapy)	121
Overall Study	NOT COMPLETED	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	101

Source ClinicalTrials.gov

Adverse events280

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	Anemia	Blood and lymphatic system disorders	Arm A (Combination Chemotherapy)	16	308	16
other	Anemia	Blood and lymphatic system disorders	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	16	318	16
other	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	Arm A (Combination Chemotherapy)	1	308	1
other	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	1	318	1
other	Bone marrow hypocellular	Blood and lymphatic system disorders	Arm A (Combination Chemotherapy)	0	308	0
other	Bone marrow hypocellular	Blood and lymphatic system disorders	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	1	318	1
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm A (Combination Chemotherapy)	28	308	28
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	25	318	25
other	Left ventricular systolic dysfunction	Cardiac disorders	Arm A (Combination Chemotherapy)	2	308	2
other	Left ventricular systolic dysfunction	Cardiac disorders	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	0	318	0

1 to 10 of 280Source ClinicalTrials.gov

See all 280 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A (Combination Chemotherapy)	51	308
Total, all-cause mortality	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	42	318
Total, other adverse events	Arm A (Combination Chemotherapy)	105	308
Total, other adverse events	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	91	318
Total, serious adverse events	Arm A (Combination Chemotherapy)	8	308
Total, serious adverse events	Arm B (Combination Chemotherapy, Topotecan Hydrochloride)	11	318

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34652968	DERIVED

Source PubMed

Grants4

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	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
P30CA013330	Cancer Center Support Grant	STEIDL, ULRICH	ALBERT EINSTEIN COLLEGE OF MEDICINE	NATIONAL CANCER INSTITUTE	1985 to 2025	NIH RePORTER
U10CA180830	NCI NCTN- Network Lead Academic Participating Site: USC	LENZ, HEINZ JOSEF; EL-KHOUEIRY, ANTHONY BOUTROS; QUINN, DAVID IAN	UNIVERSITY OF SOUTHERN CALIFORNIA	NATIONAL CANCER INSTITUTE	2014 to 2018	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER

Trial comparisons2

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

Comparison	Source
Arm A (Combination Chemotherapy) vs Arm B (Combination Chemotherapy, Topotecan Hydrochloride): deaths from any cause	Trial comparisons
Arm A (Combination Chemotherapy) vs Arm B (Combination Chemotherapy, Topotecan Hydrochloride): serious adverse events	Trial comparisons

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/NCT01231906

GET https://conductscience.org/api/trials/v1/NCT01231906/events?page=2

API reference For AI assistants