CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 642 enrolled
Drug / intervention
Cyclophosphamide +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01231906
NCT01231906Phase 3Completed

A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma

Children's Oncology Group·interventional·Posted Nov 1, 2010·Updated Jan 23, 2026

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide, Dexrazoxane, and 6 other interventions for Localized Extraskeletal Ewing Sarcoma and 2 related conditions. Completed, enrolled 642 participants across 243 sites in 6 countries.

Detailed Summary

This trial examined the outcome benefit to patients of adding a new chemotherapy drug combination to the established treatment approach for patients with extracranial Ewing sarcoma, that had not spread from the primary site to other places in the body. The trial randomly assigned patients at the time of study entry to receive established standard treatment with the following 5-drugs: vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide and etoposide. The outcome for patients receiving the standard 5-drug combination was compared to the outcome for patients who received the same 5-drugs with an additional drug, topotecan hydrochloride delivered in a novel combination with vincristine sulfate and cyclophosphamide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, Puerto Rico, Saudi Arabia, United States

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2010
Enrollment StartNov 24, 2010
Primary CompletionMar 31, 2020
Study CompletionDec 31, 2025
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 15.7 years ago

Interventions

Cyclophosphamidedrug

Given IV

Dexrazoxanedrug

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Ifosfamidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Topotecan Hydrochloridedrug

Given IV

Vincristine Sulfatedrug

Given IV