drugset / Trial / NCT01231906

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

NCT01231906

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Topotecan Small molecule Intravenous
Subject Vincristine Small molecule Intravenous
Background Dexrazoxane Small molecule
Background Doxorubicin Other / unclassified Intravenous
Background Etoposide Small molecule Intravenous
Background Ifosfamide Small molecule Intravenous