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

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.