A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes
- Compare the recurrence-free interval and survival in patients with stage I, II, III, or
IVA squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated
with adjuvant radiotherapy with or without cisplatin.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
primary surgical resection (yes vs no) and node status (N1 vs N2). Patients are randomized
to one of two treatment arms.
- Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks.
- Arm II: Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV
over 1 hour on days 1, 8, 15, 22, 29, and 36.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 4.5 years.
Allocation: Randomized, Primary Purpose: Treatment
Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Chao Family Comprehensive Cancer Center||Orange, California 92868|
|University of Colorado Cancer Center||Denver, Colorado 80262|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|Cancer Center of Albany Medical Center||Albany, New York 12208|
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Barrett Cancer Center, The University Hospital||Cincinnati, Ohio 45219|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|University of Oklahoma College of Medicine||Oklahoma City, Oklahoma 73190|
|Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033|
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|
|Tacoma General Hospital||Tacoma, Washington 98405|
|Ellis Fischel Cancer Center - Columbia||Columbia, Missouri 65203|
|Community Hospital of Los Gatos||Los Gatos, California 95032|
|Holden Comprehensive Cancer Center at The University of Iowa||Iowa City, Iowa 52242-1009|
|Tufts University School of Medicine||Boston, Massachusetts 02111|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Brookview Research, Inc.||Nashville, Tennessee 37203|
|Mallinckrodt Institute of Radiology||Saint Louis, Missouri 63110|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Schneider Children's Hospital at North Shore||Manhasset, New York 11030|
|Fletcher Allen Health Care - Medical Center Campus||Burlington, Vermont 05401|
|M.D. Anderson CCOP Research Base||Houston, Texas 77030-4009|