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

• Status: Completed
• Trial end date: 2012-01-20
• Target enrollment: 0
• Participant gender: Female

Summary

This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin

Criteria

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