RATIONALE: Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with cisplatin followed by surgery in treating patients who have locally advanced cancer of the vulva.

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

OBJECTIVES:

• 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.
• 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.

PROJECTED ACCRUAL: A total of 25-58 patients will be accrued for this study within 1.8-2.3 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS: Age

• Any age

Performance status

• GOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times normal
• Alkaline phosphatase no greater than 3 times normal
• SGOT no greater than 3 times normal

Renal

• Creatinine no greater than 2.0 mg/dL

Gastrointestinal

• No gastrointestinal bleeding
• No severe gastrointestinal symptoms

Other

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic radiotherapy
• No concurrent boost brachytherapy

Surgery

• Not specified

Other

• No prior anticancer therapy that would contraindicate study therapy

Study chairs or principal investigators

David Harry Moore, MD,  Study Chair,  Indiana University Cancer Center   
Wui-jin Koh, MD,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000322259; GOG-0205
Record last reviewed:  August 2003
Record first received:  September 10, 2003
ClinicalTrials.gov Identifier:  NCT00068406
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20