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

Phase 2

Completed

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

Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Cisplatin
Procedure: Conventional Surgery

Registration Number: NCT00068406

Lead Sponsor: Gynecologic Oncology Group

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 61

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (conventional surgery, radiation therapy, cisplatin)	3-Dimensional Conformal Radiation Therapy	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.
Treatment (conventional surgery, radiation therapy, cisplatin)	Conventional Surgery	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.
Treatment (conventional surgery, radiation therapy, cisplatin)	Cisplatin	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.

Primary Outcome Measures

Name	Time	Method
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment	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
Complete Clinical and Pathologic Response	Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of 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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (103): University of Alabama at Birmingham Cancer Center
🇺🇸
Birmingham, Alabama, United States
Banner Thunderbird Medical Center
🇺🇸
Glendale, Arizona, United States
Banner Good Samaritan Medical Center
🇺🇸
Phoenix, Arizona, United States
Western Regional CCOP
🇺🇸
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
USC / Norris Comprehensive Cancer Center
🇺🇸
Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
🇺🇸
Orange, California, United States
Colorado Gynecologic Oncology Group
🇺🇸
Aurora, Colorado, United States
North Colorado Medical Center
🇺🇸
Greeley, Colorado, United States
McKee Medical Center
🇺🇸
Loveland, Colorado, United States
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University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States