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, or stage II, IIIB, or IVA cancer of the uterine cervix or stage II-IVA vaginal cancer
Categories (click each to see list of all clinical trials associated with that category): Gynecology (GYN)
Current Status: Open to accrual
Phase: II
Principal Investigator: Rodabaugh, Kerry
Contact Information:
Pamela Nielsen
pnielsen@nebraskamed.com
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02466971#eligibility
Summary
PRIMARY OBJECTIVES:
I. 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.
SECONDARY OBJECTIVES:
I. To determine the post-therapy 3-month fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) metabolic complete rate of response rate in the cervix and vaginal by treatment arm.
II. To determine overall survival after triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy.
III. To evaluate incidence and severity of hematologic and gastrointestinal (GI) adverse events by radiation modality; image guided intensity modulated radiation therapy (IG-IMRT) versus conventional pelvic radiotherapy.
IV. To summarize and compare differences in acute adverse events (Common Terminology Criteria for Adverse Events [CTCAE], version [v]4.0) by treatment arm and radiation modality.
V. 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.