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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
The purpose of this study is to compare any good or bad effects of adding triapine to the usual cisplatin chemotherapy and radiation therapy, compared to using cisplatin chemotherapy and radiation therapy alone. Triapine is an experimental drug being tested in the treatment of cervical cancer to improve the effects of standard radiotherapy with concurrent chemotherapy.
1.1 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. 1.2 Secondary Objectives: 1.2.1 To determine the post-therapy 3-month 18F-FDG PET/CT metabolic complete response rate in the uterine cervix and vaginal by treatment arm. 1.2.2 To determine overall survival after triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy. 1.2.3 To test the hypothesis that image guided intensity modulated radiation therapy (IG-IMRT) reduces hematologic (as assessed by clinical laboratory and positron emission tomography tests) and gastrointestinal (GI) toxicity compared to conventional pelvic radiotherapy. 1.2.4 To test the hypothesis that IG-IMRT increases quality of life, with equal or superior progression-free survival and overall survival, compared to conventional pelvic radiotherapy. 1.2.5 To summarize and compare differences in acute adverse events (CTCAE, v4.0) by treatment arm and radiation modality. 1.2.6 To summarize and compare differences in chronic or late (>/= 30-days from off study treatment date) adverse events (CTCAE, v4.0) by treatment arm and by radiation modality. 1.3 Tertiary Objectives: 1.3.1 To determine peripheral blood methemoglobin proportion before and after triapine infusion (optional for Arm 2 patients). 1.3.2 To determine whether knowledge-based planning (KBP) can improve IG-IMRT plans compared to plans that would have been delivered without KBP, estimate the resulting toxicity reduction using NTCP models, and determine whether KBP should be a requirement for future IG-IMRT protocols.
Triapine (); cisplatin ()