Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
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.
OBJECTIVES:

 -  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.
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