A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Purpose

This randomized phase II 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.

Primary Outcome Measures

1. Progression-free survival (PFS) [ Time Frame: Time (in months) since registration to date first documented recurrence/progression, death or last follow-up visit (contact), assessed up to 5 years.

Product-limit estimates according to the method of Kaplan and Meier and the one sided log-rank test (alpha = 0.1) will be used to compare survival endpoint (PFS) between treatment arms. In addition, adjusted hazard ratios and respective 95% confidence intervals will be calculated using the Cox proportional hazards regression model.

Age

18 to 65
65 and over

Gender

Female

Monetary compensation

No

Can be done from home

No

Keywords

Cisplatin, Triapine

Principal Investigator

Merry Jennifer Markham, MD

Sponsoring Group

Department of Medicine

Department

Department of Medicine

Contact Information

merry.markham@medicine.ufl.edu

352.265.0725


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