Clinical Trial COG AEWS1031
- A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
- Principal Investigator
- David Walterhouse
- Status: SUSPENDED
- Study Type: Therapeutic, Treatment
- Protocol No:.COG AEWS1031
- The purpose of this study is twofold. The first purpose is to evaluate if the addition of vincristine/topotecan/cyclophosphamide (VTC) to standard chemotherapy can improve the treatment of Ewing sarcoma. The second purpose is to find out if PET scans could be useful in evaluating the beneficial effects of the treatment.
- The current standard treatment for localized Ewing sarcoma is chemotherapy (cancer fighting medicine) and then either surgically remove or treat with radiation therapy. Some patients have both surgery and radiation therapy. The standard chemotherapy combination is vincristine, doxorubicin and cyclophosphamide (VDC) and ifosfamide and etoposide (IE). VTC has been useful in treating people who have had a recurrence of Ewing sarcoma and also has been well-tolerated by people with other types of sarcoma. Early results in some studies suggest that adding VTC to the standard chemotherapy may get rid of the cancer better.
Some of the eligibility criteria include:
- Participants must be 50 years old or younger.
- Participants must have newly diagnosed non-metastatic Ewing sarcoma.
- Description of Treatment
- Participants will be randomized (by chance, like flipping a coin) to one of two treatment plans called regimens. Regimen A will receive the experimental chemotherapy (VTC added to the standard treatment) and Regimen B will receive the standard chemotherapy. There are 3 stages in this treatment plan: 1) induction therapy (used to get rid or shrink of the cancer), 2) local treatment (treatment directly to the tumor, either radiation or surgery), and 3) consolidation therapy (meant to kill any remaining cancer cells). Induction therapy consists of six two -week cycles (12 weeks). PET scans will be used after induction therapy to assess the tumor. Participants will then begin local treatment. After local treatment, participants will receive eleven 2-week cycles (22 weeks) of consolidation therapy.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 29-Apr-16 12:52 PM
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