Ewing Sarcoma Treatment with Combination Chemotherapy Including Topotecan – Phase III

AEWS1031: Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma

Protocol Description

This multicenter trial by the Children’s Oncology Group studies standard combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan in treating patients with non-metastatic extracranial Ewing sarcoma. The combination of topotecan and cyclophosphamide has been found to be useful in treating some patients with recurrent Ewing sarcoma, and the combination of vincristine, topotecan, and cyclophosphamide (VTC) has been well tolerated in people with other types of sarcoma. A recent COG study added VTC to standard therapy for localized Ewing sarcoma and the early results indicate that VTC can be used in this way.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting patients of both genders up to age 50, who have been newly diagnosed with extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue.
Males and Females: Up to age 50


Study participants will be randomly assigned to either receive standard combination chemotherapy for their condition or chemotherapy that includes topotecan. As with standard care, the treatment plan involves induction therapy (12 weeks), local control and consolidation therapy (22 weeks). Local control may include surgery, radiation therapy or both.
Visits: Participants receive alternating cycles of chemotherapy on both an inpatient and outpatient basis.
Duration: Approximately 9 months

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AEWS1031)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Jean Tersak, MD