Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva
Stage III Vulvar Cancer, Stage IVB Vulvar Cancer, Vulvar Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Stage III Vulvar Cancer
Eligibility Criteria
Inclusion Criteria: Diagnosis of locally advanced squamous cell carcinoma of the vulva T3 or T4 (N0-3, M0) Not amenable to surgical resection by standard radical vulvectomy Previously untreated disease No recurrent disease No vulvar melanoma or sarcoma Performance status - GOG 0-3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times normal Alkaline phosphatase no greater than 3 times normal SGOT no greater than 3 times normal Creatinine no greater than 2.0 mg/dL No gastrointestinal bleeding No severe gastrointestinal symptoms Capable of tolerating a radical course of chemoradiotherapy No septicemia No severe infection No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No circumstance that would preclude study completion or follow-up No prior cytotoxic chemotherapy No prior pelvic radiotherapy No concurrent boost brachytherapy No prior anticancer therapy that would contraindicate study therapy
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Banner Thunderbird Medical Center
- Banner Good Samaritan Medical Center
- Western Regional CCOP
- University of Arkansas for Medical Sciences
- USC / Norris Comprehensive Cancer Center
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Colorado Gynecologic Oncology Group
- North Colorado Medical Center
- McKee Medical Center
- Hartford Hospital
- The Hospital of Central Connecticut
- Yale University
- Mayo Clinic in Florida
- Lakeland Regional Cancer Center
- UF Cancer Center at Orlando Health
- Central Georgia Gynecologic Oncology
- Memorial University Medical Center
- Rush - Copley Medical Center
- University of Illinois
- Decatur Memorial Hospital
- Joliet Oncology-Hematology Associates Limited
- Memorial Medical Center
- Carle Clinic-Urbana Main
- Elkhart General Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- Gynecologic Oncology of Indiana
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Saint Joseph Regional Medical Center-Mishawaka
- Memorial Hospital of South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- University of Iowa/Holden Comprehensive Cancer Center
- Providence Medical Center
- Lawrence Memorial Hospital
- Radiation Oncology Practice Corporation Southwest
- University of Kentucky/Markey Cancer Center
- Woman's Hospital
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Baystate Medical Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium NCORP
- Beaumont Hospital-Dearborn
- Saint John Hospital and Medical Center
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Spectrum Health at Butterworth Campus
- Spectrum Health-Blodgett Campus
- Gynecologic Oncology of West Michigan PLLC
- Allegiance Health
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Saint Mary's of Michigan
- Lakeland Hospital
- Saint John Macomb-Oakland Hospital
- University of Minnesota/Masonic Cancer Center
- Mayo Clinic
- Centerpoint Medical Center LLC
- Mercy Hospital-Joplin
- Radiation Oncology Practice Corporation South
- Radiation Oncology Practice Corporation - North
- Washington University School of Medicine
- University of Nebraska Medical Center
- Rutgers Cancer Institute of New Jersey
- Stony Brook University Medical Center
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Oncology Specialists
- Wake Forest University Health Sciences
- University of Cincinnati
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Mount Carmel Health Center West
- Lake University Ireland Cancer Center
- University of Oklahoma Health Sciences Center
- Cancer Care Associates-Midtown
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Abington Memorial Hospital
- Lehigh Valley Hospital-Cedar Crest
- Penn State Milton S Hershey Medical Center
- Temple University Hospital
- Women and Infants Hospital
- Black Hills Obstetrics and Gynecology
- Knoxville Gynecologic Cancer Specialists PC
- University of Texas Medical Branch
- Cottonwood Hospital Medical Center
- Carilion Clinic Gynecological Oncology
- Fred Hutchinson Cancer Research Center
- University of Washington Medical Center
- Northwest Medical Specialties PLLC
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
Arms of the Study
Arm 1
Experimental
Treatment (conventional surgery, radiation therapy, cisplatin)
Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity. Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.