Phase 2/3Terminated
Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body
Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing Sarcoma
- Sponsor
- Children's Oncology Group (Research network)
- Enrolment
- 2 enrolled
- Conditions
- CIC-Rearranged Sarcoma; Metastatic Ewing Sarcoma; Metastatic High Grade Sarcoma; Metastatic Undifferentiated Round Cell Sarcoma; Metastatic Undifferentiated Sarcoma, Not Otherwise Specified; Round Cell Sarcoma With EWSR1-non-ETS Fusion; Sarcoma With BCOR Genetic Alterations
- Interventions
- Biopsy Procedure; Biospecimen Collection; Bone Marrow Aspiration; Bone Marrow Biopsy; Computed Tomography; Cyclophosphamide; Doxorubicin Hydrochloride; Echocardiography Test; Etoposide; Fludeoxyglucose F-18; Ifosfamide; Irinotecan Hydrochloride
- Ages
- children, adults
- Registry
- NCT06820957
From the registry
This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sarcomas that have spread from where they first started (primary site) to other places in the body (metastatic). Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Regorafenib, a type of kinase inhibitor and a type of antiangiogenesis agent, blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill…
Primary outcomes
- Time to event-free survival (EFS) post-Consolidation I (C1)