Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed primary invasive carcinoma of the uterine cervix Stages IB2, II, IIIB, and IVA disease Any cell type No known metastasis to scalene nodes or organs outside the radiation field No known intraperitoneal metastases No evidence of extrapelvic disease based on negative CT or PET scan Must enroll within 8 weeks of diagnosis Performance status - GOG 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Creatinine normal Creatinine clearance > 50 mL/min Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except nonmelanoma skin cancer No septicemia or severe infection No other medical or psychiatric condition that would preclude study compliance No prior chemotherapy for any prior malignancy No prior cytotoxic chemotherapy for this malignancy No prior radiotherapy for any prior malignancy No prior pelvic or abdominal radiotherapy for this malignancy No prior therapy for this malignancy
Sites / Locations
- University of Chicago Comprehensive Cancer Center
- University of Iowa Hospitals and Clinics
- University of Missouri - Ellis Fischel
- Cooper Hospital University Medical Center
- MetroHealth Medical Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Riverside Methodist Hospital
- University of Oklahoma Health Sciences Center
- Cancer Care Associates-Midtown
- Tulsa Cancer Institute
Arms of the Study
Arm 1
Experimental
Treatment (topotecan hydrochloride, radiation, cisplatin)
Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.