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

Vulvar Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068406
• Other study ID #: GOG-0205
• Secondary ID: NCI-2009-00582CD
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2003
• Last updated: October 17, 2017
• Start date: January 2005
• Est. completion date: January 20, 2012

Study information

• Verified date: October 2011
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 20, 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Stage III Vulvar Cancer
• Stage IVB Vulvar Cancer
• Vulvar Neoplasms
• Vulvar Squamous Cell Carcinoma

Intervention

Radiation:
• 3-Dimensional Conformal Radiation Therapy

Drug:
• Cisplatin
Given IV

Procedure:
• Conventional Surgery

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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