RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy combined with chemotherapy kills more tumor cells than radiation therapy alone in treating cancer of the vulva. PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy with or without cisplatin in treating patients who have stage I, stage II, or stage III cancer of the vulva.

Condition	Treatment or Intervention	Phase
stage I vulvar cancer stage III vulvar cancer stage II vulvar cancer squamous cell carcinoma of the vulva	Procedure: chemotherapy  Procedure: radiation therapy  Drug: cisplatin	Phase III

Further Study Details: 

OBJECTIVES: I. Compare the recurrence-free interval and survival in patients with stage I, II, or III squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated with adjuvant radiotherapy with or without cisplatin. II. Compare the toxicity of these regimens in these patients.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed stage I, II, or III (at clinical presentation) 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

--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

--Patient Characteristics--

• Age: Any age
• Performance status: GOG 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3
• 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

California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States
      Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
Iowa
      Holden Comprehensive Cancer Center at The University of Iowa, Iowa City,  Iowa,  52242-1009,  United States
Massachusetts
      Tufts University School of Medicine, Boston,  Massachusetts,  02111,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Mallinckrodt Institute of Radiology, Saint Louis,  Missouri,  63108,  United States
New York
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States
      Schneider Children's Hospital at North Shore, Manhasset,  New York,  11030,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45267-0502,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States
Tennessee
      Brookview Research, Inc., Nashville,  Tennessee,  37203,  United States
Texas
      M.D. Anderson CCOP Research Base, Houston,  Texas,  77030-4009,  United States
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
Vermont
      Fletcher Allen Health Care - Medical Center Campus, Burlington,  Vermont,  05401,  United States
Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
Canada, Alberta
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, Ontario
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada

Study chairs or principal investigators

Gillian Monica Thomas,  Study Chair,  Gynecologic Oncology Group   

Study ID Numbers:  CDR0000068103; GOG-0185
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006096
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08