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): Case Western Reserve University
🇺🇸
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
🇺🇸
Cleveland, Ohio, United States
Gynecologic Oncology of Indiana
🇺🇸
Indianapolis, Indiana, United States
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Saint John Hospital and Medical Center
🇺🇸
Detroit, Michigan, United States
Western Regional CCOP
🇺🇸
Phoenix, Arizona, United States
Mayo Clinic in Florida
🇺🇸
Jacksonville, Florida, United States
Banner Thunderbird Medical Center
🇺🇸
Glendale, Arizona, United States
University of Illinois
🇺🇸
Chicago, Illinois, United States
University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Decatur Memorial Hospital
🇺🇸
Decatur, Illinois, United States
Elkhart General Hospital
🇺🇸
Elkhart, Indiana, United States
Banner Good Samaritan Medical Center
🇺🇸
Phoenix, Arizona, United States
The Hospital of Central Connecticut
🇺🇸
New Britain, Connecticut, United States
McKee Medical Center
🇺🇸
Loveland, Colorado, United States
IU Health La Porte Hospital
🇺🇸
La Porte, Indiana, United States
USC / Norris Comprehensive Cancer Center
🇺🇸
Los Angeles, California, United States
Central Georgia Gynecologic Oncology
🇺🇸
Macon, Georgia, United States
Rush - Copley Medical Center
🇺🇸
Aurora, Illinois, United States
Providence Medical Center
🇺🇸
Kansas City, Kansas, United States
Indiana University/Melvin and Bren Simon Cancer Center
🇺🇸
Indianapolis, Indiana, United States
Woman's Hospital
🇺🇸
Baton Rouge, Louisiana, United States
Lawrence Memorial Hospital
🇺🇸
Lawrence, Kansas, United States
Community Howard Regional Health
🇺🇸
Kokomo, Indiana, United States
Memorial Hospital of South Bend
🇺🇸
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
🇺🇸
South Bend, Indiana, United States
Radiation Oncology Practice Corporation Southwest
🇺🇸
Overland Park, Kansas, United States
Baystate Medical Center
🇺🇸
Springfield, Massachusetts, United States
University of Minnesota/Masonic Cancer Center
🇺🇸
Minneapolis, Minnesota, United States
Centerpoint Medical Center LLC
🇺🇸
Independence, Missouri, United States
Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
🇺🇸
Tulsa, Oklahoma, United States
Hurley Medical Center
🇺🇸
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
🇺🇸
Flint, Michigan, United States
Saint Joseph Mercy Oakland
🇺🇸
Pontiac, Michigan, United States
Sparrow Hospital
🇺🇸
Lansing, Michigan, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
🇺🇸
Baltimore, Maryland, United States
Gynecologic Oncology of West Michigan PLLC
🇺🇸
Grand Rapids, Michigan, United States
Allegiance Health
🇺🇸
Jackson, Michigan, United States
Beaumont Hospital-Dearborn
🇺🇸
Dearborn, Michigan, United States
Spectrum Health-Blodgett Campus
🇺🇸
Grand Rapids, Michigan, United States
Saint Mary's of Michigan
🇺🇸
Saginaw, Michigan, United States
Fred Hutchinson Cancer Research Center
🇺🇸
Seattle, Washington, United States
Black Hills Obstetrics and Gynecology
🇺🇸
Rapid City, South Dakota, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸
Charlotte, North Carolina, United States
Rutgers Cancer Institute of New Jersey
🇺🇸
New Brunswick, New Jersey, United States
Mercy Hospital-Joplin
🇺🇸
Joplin, Missouri, United States
Cancer Care Associates-Midtown
🇺🇸
Tulsa, Oklahoma, United States
Ohio State University Comprehensive Cancer Center
🇺🇸
Columbus, Ohio, United States
Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
Temple University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
Carilion Clinic Gynecological Oncology
🇺🇸
Roanoke, Virginia, United States
Saint Mary's Hospital
🇺🇸
Green Bay, Wisconsin, United States
Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
Lake University Ireland Cancer Center
🇺🇸
Mentor, Ohio, United States
Joliet Oncology-Hematology Associates Limited
🇺🇸
Joliet, Illinois, United States
Franciscan Saint Anthony Health-Michigan City
🇺🇸
Michigan City, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
🇺🇸
Mishawaka, Indiana, United States
Saint Mary Mercy Hospital
🇺🇸
Livonia, Michigan, United States
Saint John Macomb-Oakland Hospital
🇺🇸
Warren, Michigan, United States
Mount Carmel Health Center West
🇺🇸
Columbus, Ohio, United States
Lehigh Valley Hospital-Cedar Crest
🇺🇸
Allentown, Pennsylvania, United States
Women and Infants Hospital
🇺🇸
Providence, Rhode Island, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Northwest Medical Specialties PLLC
🇺🇸
Tacoma, Washington, United States
Saint Vincent Hospital
🇺🇸
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
🇺🇸
La Crosse, Wisconsin, United States
Carle Clinic-Urbana Main
🇺🇸
Urbana, Illinois, United States
Green Bay Oncology Limited at Saint Mary's Hospital
🇺🇸
Green Bay, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
🇺🇸
Green Bay, Wisconsin, United States
Memorial University Medical Center
🇺🇸
Savannah, Georgia, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
🇺🇸
Orange, California, United States
North Colorado Medical Center
🇺🇸
Greeley, Colorado, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
South Bend Clinic
🇺🇸
South Bend, Indiana, United States
Spectrum Health at Butterworth Campus
🇺🇸
Grand Rapids, Michigan, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Knoxville Gynecologic Cancer Specialists PC
🇺🇸
Knoxville, Tennessee, United States
University of Alabama at Birmingham Cancer Center
🇺🇸
Birmingham, Alabama, United States
Colorado Gynecologic Oncology Group
🇺🇸
Aurora, Colorado, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
UF Cancer Center at Orlando Health
🇺🇸
Orlando, Florida, United States
University of Kentucky/Markey Cancer Center
🇺🇸
Lexington, Kentucky, United States
Saint Joseph Mercy Hospital
🇺🇸
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP
🇺🇸
Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Radiation Oncology Practice Corporation South
🇺🇸
Kansas City, Missouri, United States
Radiation Oncology Practice Corporation - North
🇺🇸
Kansas City, Missouri, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸
Chapel Hill, North Carolina, United States
Novant Health Oncology Specialists
🇺🇸
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
University of Wisconsin Hospital and Clinics
🇺🇸
Madison, Wisconsin, United States
Memorial Medical Center
🇺🇸
Springfield, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸
Iowa City, Iowa, United States
Lakeland Regional Cancer Center
🇺🇸
Lakeland, Florida, United States
Saint Joseph Mercy Port Huron
🇺🇸
Port Huron, Michigan, United States
Lakeland Hospital
🇺🇸
Saint Joseph, Michigan, United States
Cottonwood Hospital Medical Center
🇺🇸
Murray, Utah, United States