⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT00068406

Study Description

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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Hartford Hospital, Hartford, Connecticut, United States

The Hospital of Central Connecticut, New Britain, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Mayo Clinic in Florida, Jacksonville, Florida, United States

Lakeland Regional Cancer Center, Lakeland, Florida, United States

UF Cancer Center at Orlando Health, Orlando, Florida, United States

Central Georgia Gynecologic Oncology, Macon, Georgia, United States

Memorial University Medical Center, Savannah, Georgia, United States

Rush - Copley Medical Center, Aurora, Illinois, United States

University of Illinois, Chicago, Illinois, United States

Decatur Memorial Hospital, Decatur, Illinois, United States

Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States

Memorial Medical Center, Springfield, Illinois, United States

Carle Clinic-Urbana Main, Urbana, Illinois, United States

Elkhart General Hospital, Elkhart, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

Gynecologic Oncology of Indiana, Indianapolis, Indiana, United States

Community Howard Regional Health, Kokomo, Indiana, United States

IU Health La Porte Hospital, La Porte, Indiana, United States

Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, United States

Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, United States

Memorial Hospital of South Bend, South Bend, Indiana, United States

South Bend Clinic, South Bend, Indiana, United States

Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States

University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

Providence Medical Center, Kansas City, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Radiation Oncology Practice Corporation Southwest, Overland Park, Kansas, United States

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Woman's Hospital, Baton Rouge, Louisiana, United States

MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, United States

Baystate Medical Center, Springfield, Massachusetts, United States

Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States

Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States

Beaumont Hospital-Dearborn, Dearborn, Michigan, United States

Saint John Hospital and Medical Center, Detroit, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States

Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States

Spectrum Health-Blodgett Campus, Grand Rapids, Michigan, United States

Gynecologic Oncology of West Michigan PLLC, Grand Rapids, Michigan, United States

Allegiance Health, Jackson, Michigan, United States

Sparrow Hospital, Lansing, Michigan, United States

Saint Mary Mercy Hospital, Livonia, Michigan, United States

Saint Joseph Mercy Oakland, Pontiac, Michigan, United States

Saint Joseph Mercy Port Huron, Port Huron, Michigan, United States

Saint Mary's of Michigan, Saginaw, Michigan, United States

Lakeland Hospital, Saint Joseph, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, Michigan, United States

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

Mayo Clinic, Rochester, Minnesota, United States

Centerpoint Medical Center LLC, Independence, Missouri, United States

Mercy Hospital-Joplin, Joplin, Missouri, United States

Radiation Oncology Practice Corporation South, Kansas City, Missouri, United States

Radiation Oncology Practice Corporation - North, Kansas City, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Stony Brook University Medical Center, Stony Brook, New York, United States

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute, Charlotte, 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 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

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Mount Carmel Health Center West, Columbus, Ohio, United States

Lake University Ireland Cancer Center, Mentor, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Cancer Care Associates-Midtown, Tulsa, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States

Abington Memorial Hospital, Abington, Pennsylvania, United States

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States

Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States

Temple University Hospital, Philadelphia, Pennsylvania, United States

Women and Infants Hospital, Providence, Rhode Island, United States

Black Hills Obstetrics and Gynecology, Rapid City, South Dakota, United States

Knoxville Gynecologic Cancer Specialists PC, Knoxville, Tennessee, United States

University of Texas Medical Branch, Galveston, Texas, United States

Cottonwood Hospital Medical Center, Murray, Utah, United States

Carilion Clinic Gynecological Oncology, Roanoke, Virginia, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

University of Washington Medical Center, Seattle, Washington, United States

Northwest Medical Specialties PLLC, Tacoma, Washington, United States

Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States

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

Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

Contact Details

Name: David Moore

Affiliation: Gynecologic Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: