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Spots Global Cancer Trial Database for Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva

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Trial Identification

Brief Title: Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva

Official Title: A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva (NCT #01595061)

Study ID: NCT01595061

Study Description

Brief Summary: This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the efficacy of cisplatin, gemcitabine (gemcitabine hydrochloride), and intensity-modulated radiation therapy (IMRT) in achieving a complete pathologic response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva. SECONDARY OBJECTIVES: I. To determine the efficacy of cisplatin, gemcitabine, and IMRT in achieving a complete clinical response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva. II. To determine the vulvar progression-free survival and groin progression-free survival in women treated with cisplatin, gemcitabine and IMRT for locally advanced vulvar carcinoma. III. To determine the toxicity and surgical morbidity of the combined modality approach of cisplatin, gemcitabine and IMRT followed by reduced-scope surgery for the treatment of locally-advanced vulvar carcinoma. OUTLINE: Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States

Anchorage Radiation Therapy Center, Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States

Alaska Women's Cancer Care, Anchorage, Alaska, United States

Anchorage Oncology Centre, Anchorage, Alaska, United States

Katmai Oncology Group, Anchorage, Alaska, United States

Providence Alaska Medical Center, Anchorage, Alaska, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

Hartford Hospital, Hartford, Connecticut, United States

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

Beebe Medical Center, Lewes, Delaware, United States

Christiana Gynecologic Oncology LLC, Newark, Delaware, United States

Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States

Helen F Graham Cancer Center, Newark, Delaware, United States

Medical Oncology Hematology Consultants PA, Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States

Beebe Health Campus, Rehoboth Beach, Delaware, United States

TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, United States

Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, United States

Augusta University Medical Center, Augusta, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States

The Cancer Center of Hawaii-Pali Momi, 'Aiea, Hawaii, United States

Queen's Medical Center, Honolulu, Hawaii, United States

University of Hawaii Cancer Center, Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States

Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States

Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States

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

Saint Joseph Medical Center, Bloomington, Illinois, United States

Illinois CancerCare-Bloomington, Bloomington, Illinois, United States

Illinois CancerCare-Canton, Canton, Illinois, United States

Memorial Hospital of Carbondale, Carbondale, Illinois, United States

SIH Cancer Institute, Carterville, Illinois, United States

Illinois CancerCare-Carthage, Carthage, Illinois, United States

Centralia Oncology Clinic, Centralia, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Carle on Vermilion, Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States

Decatur Memorial Hospital, Decatur, Illinois, United States

Carle Physician Group-Effingham, Effingham, Illinois, United States

Crossroads Cancer Center, Effingham, Illinois, United States

Illinois CancerCare-Eureka, Eureka, Illinois, United States

Illinois CancerCare-Galesburg, Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States

Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States

Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale, Illinois, United States

Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States

Illinois CancerCare-Macomb, Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States

Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States

Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States

Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States

Radiation Oncology of Northern Illinois, Ottawa, Illinois, United States

Illinois CancerCare-Pekin, Pekin, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States

Illinois CancerCare-Peoria, Peoria, Illinois, United States

OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States

Methodist Medical Center of Illinois, Peoria, Illinois, United States

OSF Saint Francis Medical Center, Peoria, Illinois, United States

Illinois CancerCare-Peru, Peru, Illinois, United States

Valley Radiation Oncology, Peru, Illinois, United States

Illinois CancerCare-Princeton, Princeton, Illinois, United States

Central Illinois Hematology Oncology Center, Springfield, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Springfield Clinic, Springfield, Illinois, United States

Memorial Medical Center, Springfield, Illinois, United States

Southwest Illinois Health Services LLP, Swansea, Illinois, United States

Carle Cancer Center, Urbana, Illinois, United States

The Carle Foundation Hospital, Urbana, Illinois, United States

Rush-Copley Healthcare Center, Yorkville, Illinois, United States

Parkview Hospital Randallia, Fort Wayne, Indiana, United States

Parkview Regional Medical Center, Fort Wayne, Indiana, United States

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

Saint Elizabeth Medical Center South, Edgewood, Kentucky, United States

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

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

Ochsner Baptist Medical Center, New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States

Christiana Care - Union Hospital, Elkton, Maryland, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Brigham and Women's Hospital, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Baystate Medical Center, Springfield, Massachusetts, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, United States

Saint Francis Medical Center, Cape Girardeau, Missouri, United States

Southeast Cancer Center, Cape Girardeau, Missouri, United States

Capital Region Southwest Campus, Jefferson City, Missouri, United States

Mercy Hospital Joplin, Joplin, Missouri, United States

Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States

Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States

Barnes-Jewish Hospital, Saint Louis, Missouri, United States

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

Missouri Baptist Medical Center, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States

Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills, Missouri, United States

Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States

Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

Cooper Hospital University Medical Center, Camden, New Jersey, United States

MD Anderson Cancer Center at Cooper-Voorhees, Voorhees, New Jersey, United States

Women's Cancer Care Associates LLC, Albany, New York, United States

Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States

AdventHealth Hendersonville, Hendersonville, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Sanford Bismarck Medical Center, Bismarck, North Dakota, United States

Sanford Broadway Medical Center, Fargo, North Dakota, United States

Sanford Clinic North-Fargo, Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States

Summa Health System - Akron Campus, Akron, Ohio, United States

UHHS-Chagrin Highlands Medical Center, Beachwood, Ohio, United States

University of Cincinnati Cancer Center-UC Medical Center, 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

Grandview Hospital, Dayton, Ohio, United States

Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States

UHHS-Westlake Medical Center, Westlake, Ohio, United States

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

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

Saint Charles Health System, Bend, Oregon, United States

Clackamas Radiation Oncology Center, Clackamas, Oregon, United States

Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, United States

Bay Area Hospital, Coos Bay, Oregon, United States

Providence Newberg Medical Center, Newberg, Oregon, United States

Providence Portland Medical Center, Portland, Oregon, United States

Providence Saint Vincent Medical Center, Portland, Oregon, United States

Saint Charles Health System-Redmond, Redmond, Oregon, United States

Jefferson Abington Hospital, Abington, Pennsylvania, United States

Temple University Hospital, Philadelphia, Pennsylvania, United States

Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States

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

AnMed Health Cancer Center, Anderson, South Carolina, United States

Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States

Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States

Gibbs Cancer Center-Gaffney, Gaffney, South Carolina, United States

Greenville Health System Cancer Institute-Andrews, Greenville, South Carolina, United States

Saint Francis Hospital, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States

Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States

Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States

Gibbs Cancer Center-Pelham, Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States

Spartanburg Medical Center, Spartanburg, South Carolina, United States

Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States

Parkland Memorial Hospital, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

Memorial Hermann Texas Medical Center, Houston, Texas, United States

Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States

PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States

Providence Regional Cancer System-Centralia, Centralia, Washington, United States

Swedish Cancer Institute-Edmonds, Edmonds, Washington, United States

Providence Regional Cancer Partnership, Everett, Washington, United States

Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States

Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States

Providence Regional Cancer System-Lacey, Lacey, Washington, United States

PeaceHealth Saint John Medical Center, Longview, Washington, United States

Pacific Gynecology Specialists, Seattle, Washington, United States

Swedish Medical Center-Ballard Campus, Seattle, Washington, United States

Kaiser Permanente Washington, Seattle, Washington, United States

Swedish Medical Center-First Hill, Seattle, Washington, United States

Swedish Medical Center-Cherry Hill, Seattle, Washington, United States

PeaceHealth United General Medical Center, Sedro-Woolley, Washington, United States

Providence Regional Cancer System-Shelton, Shelton, Washington, United States

MultiCare Deaconess Cancer and Blood Specialty Center - Valley, Spokane Valley, Washington, United States

MultiCare Deaconess Cancer and Blood Specialty Center - Downtown, Spokane, Washington, United States

MultiCare Deaconess Cancer and Blood Specialty Center - North, Spokane, Washington, United States

PeaceHealth Southwest Medical Center, Vancouver, Washington, United States

Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States

Providence Regional Cancer System-Yelm, Yelm, Washington, United States

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

Contact Details

Name: Neil S Horowitz

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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