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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva

Conditions
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Stage III Vulvar Cancer, Stage IVB Vulvar Cancer, Vulvar Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: 3-Dimensional Conformal Radiation Therapy
* Drug: Cisplatin
* Procedure: Conventional Surgery


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (conventional surgery, radiation therapy, cisplatin)<br>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. | Radiation: 3-Dimensional Conformal Radiation Therapy<br> <br> * Other names: Radiation Conformal Therapy;Drug: Cisplatin<br>* Given IV<br>* Other names: Platosin;Procedure: Conventional Surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clinical and Pathologic Response | Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen. | Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response. | 
| Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period | Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0 | Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment |