A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes

Inclusion 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