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

NCT01231906 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 642

Last updated 2026-01-23

Study results available
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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.

Conditions

  • Localized Extraskeletal Ewing Sarcoma
  • Peripheral Primitive Neuroectodermal Tumor of Bone
  • Peripheral Primitive Neuroectodermal Tumor of Soft Tissues

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Dexrazoxane

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Ifosfamide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Topotecan Hydrochloride

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Patrick J Leavey · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-24
Primary Completion
2020-03-31
Completion
2025-12-31

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Puerto Rico
  • Saudi Arabia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01231906 on ClinicalTrials.gov