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NRG-GY006

NRG-GY006: 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

Principal Investigator/Co-Principal Investigator

Charles Leath, MD/Charles Kunos, MD, Ph.D

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

172-188 patients over 18-24 months

Status

Activation:  January 15, 2016

Protocol and Other Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website

CTEP Approval Letter (pdf)

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Copyright 2017 by NRG Oncology