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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Neil S Horowitz
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR