Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva
A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva
4 other identifiers
interventional
61
1 country
103
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2005
Longer than P75 for phase_2
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2003
CompletedFirst Posted
Study publicly available on registry
September 11, 2003
CompletedStudy Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2012
CompletedResults Posted
Study results publicly available
October 17, 2017
CompletedNovember 20, 2017
October 1, 2011
5.9 years
September 10, 2003
September 15, 2017
October 17, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Treatment (conventional surgery, radiation therapy, cisplatin)
EXPERIMENTALPatients 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.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (103)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Banner Thunderbird Medical Center
Glendale, Arizona, 85306, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Western Regional CCOP
Phoenix, Arizona, 85006, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Yale University
New Haven, Connecticut, 06520, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Central Georgia Gynecologic Oncology
Macon, Georgia, 31201, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
University of Illinois
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Clinic-Urbana Main
Urbana, Illinois, 61801, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Gynecologic Oncology of Indiana
Indianapolis, Indiana, 46237, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Providence Medical Center
Kansas City, Kansas, 66112, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Radiation Oncology Practice Corporation Southwest
Overland Park, Kansas, 66210, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Woman's Hospital
Baton Rouge, Louisiana, 70817, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Spectrum Health-Blodgett Campus
Grand Rapids, Michigan, 49506, United States
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, 49546, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Centerpoint Medical Center LLC
Independence, Missouri, 64057, United States
Mercy Hospital-Joplin
Joplin, Missouri, 64804, United States
Radiation Oncology Practice Corporation South
Kansas City, Missouri, 64114, United States
Radiation Oncology Practice Corporation - North
Kansas City, Missouri, 64154, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, 57701, United States
Knoxville Gynecologic Cancer Specialists PC
Knoxville, Tennessee, 37920, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Gedeon for Wei Deng, PhD.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
David Moore
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2003
First Posted
September 11, 2003
Study Start
January 1, 2005
Primary Completion
December 1, 2010
Study Completion
January 20, 2012
Last Updated
November 20, 2017
Results First Posted
October 17, 2017
Record last verified: 2011-10