drugset / Trial / NCT02466971

Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers

NCT02466971

Phase 3 Active not recruiting 450 enrolled National Cancer Institute (NCI) NRG Oncology · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

Timeline

Start
2016-05-10
Primary completion
2023-01-26
Completion
2026-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Triapine Small molecule Intravenous
Background Cisplatin Other / unclassified Intravenous