Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva

OBJECTIVES:

I. Determine the efficacy of radiotherapy and cisplatin, in terms of achieving a complete
clinical and pathological response, in patients with locally advanced squamous cell carcinoma
of the vulva that is not amenable to standard radical vulvectomy.

II. Determine the toxicity of this regimen followed by surgery in these patients.

OUTLINE: This is a multicenter study.

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.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

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