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, MD
Status
Closed to Accrual
Date Opened To Accrual
December 22 2015
Date Closed to Accrual
September 22 2022
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.