Title (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 Martin Brecher, MD
Study Number 189510
Summary Cyclophosphamide with topotecan has been demonstrated to be active in patients with recurrent and metastatic Ewing sarcoma. Vincristine has been shown to be synergistic with topotecan in xenograft models of rhabdomyosarcoma. This randomized Phase 3 trial will test the efficacy of adding vincristine-topotecan-cyclophoshamide to the interval compressed 5 drug backbone. This study will also assess initial tumor volume, histologic response to induction chemotherapy and response measured by FDG-PET as prognostic factors for even free survival in patients with non-metastatic Ewing Sarcoma.
- Age less than or equal to 50 years
- Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or PNET of bone or soft tissue are eligible for this study
- Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by institutional pathologist
- No prior chemotherapy or radiation therapy is allowed. Patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection. Patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery
- Adequate renal function, adequate liver function, and adequate cardiac function as described in section 3.2.5
- Patients must have no evidence of metastatic disease
- Patient whose tumors arise in the intra-dural soft tissue are not eligible
- Pregnant women will not be entered on this study as fetal toxicities and teratogenic effects have been noted for several of the study drugs. Pregnancy test must be obtained in female patients who are post-menarchal. Lactating females may not participate unless they have agreed not to breastfeed their infants. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment.