NRG-GY006

A Randomized Phase III 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

Principal Investigator

Charles ‘ Trey’ Leath

Status

Disease Site

Gynecologic [GY] Cervix

Phase

III

Developmental Therapeutics

No

Primary Objective

To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase progression-free survival relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix and vaginal cancer. Hypothesis: The experimental regimen, triapine (3AP) in combination with cisplatin and radiation, will increase progression-free survival (HR = 0.5089) relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix and vaginal cancer.

Patient Population

Patient has pathologic diagnosis of stage IB2 (> 5 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone.

Target Accrual

188