Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
Vulvar Cancer
About this trial
This is an interventional treatment trial for Vulvar Cancer focused on measuring stage I vulvar cancer, stage II vulvar cancer, stage III vulvar cancer, stage IVB vulvar cancer, squamous cell carcinoma of the vulva
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage I, II, III, or IVA squamous cell carcinoma of the vulva amenable to curative treatment with surgery, radiotherapy, or both At least 1 positive inguinal and/or femoral lymph node No inoperable (fixed or ulcerating) groin nodes Must not require resection of urethra or anal sphincter to achieve negative margins Must have undergone vulvar biopsy and bilateral inguinal/femoral lymph node dissection within 8 weeks of randomization No metastatic disease PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Granulocyte count at least 1,500/mm^3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy Surgery: See Disease Characteristics No more than 8 weeks since prior surgery Other: No prior therapy for another malignancy that would preclude study
Sites / Locations
- Community Hospital of Los Gatos
- Chao Family Comprehensive Cancer Center
- University of Colorado Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute
- Indiana University Cancer Center
- Holden Comprehensive Cancer Center at The University of Iowa
- Tufts University School of Medicine
- Mayo Clinic Cancer Center
- University of Mississippi Medical Center
- Ellis Fischel Cancer Center - Columbia
- Mallinckrodt Institute of Radiology
- Cancer Center of Albany Medical Center
- Schneider Children's Hospital at North Shore
- Lineberger Comprehensive Cancer Center, UNC
- Duke Comprehensive Cancer Center
- Comprehensive Cancer Center at Wake Forest University
- Barrett Cancer Center, The University Hospital
- Ireland Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Arthur G. James Cancer Hospital - Ohio State University
- University of Oklahoma College of Medicine
- Abington Memorial Hospital
- Milton S. Hershey Medical Center
- Brookview Research, Inc.
- Simmons Cancer Center - Dallas
- M.D. Anderson CCOP Research Base
- Fletcher Allen Health Care - Medical Center Campus
- Tacoma General Hospital
- Tom Baker Cancer Center - Calgary
- Toronto Sunnybrook Regional Cancer Centre