Summary

Eligibility
for people ages up to 50 years (full criteria)
Location
at Oakland, California and other locations
Dates
study started

Description

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.

Official Title

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

Details

Keywords

Localized Extraskeletal Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissues, Sarcoma, Ewing Sarcoma, Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Neuroectodermal Tumors, Primitive, Peripheral, Soft Tissue Neoplasms, Cyclophosphamide, Ifosfamide, Isophosphamide mustard, Doxorubicin, Liposomal doxorubicin, Etoposide, Vincristine, Etoposide phosphate, Topotecan, Podophyllotoxin, Dexrazoxane, Razoxane, 3,6-bis(5-chloro-2-piperidyl)-2,5-piperazinedione, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Topotecan Hydrochloride, Vincristine Sulfate

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Children's Oncology Group
Links
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
ID
NCT01231906
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 642 people participating
Last Updated