Spots Global Cancer Trial Database for Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
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Trial Identification
Brief Title: Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
Official Title: A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma
Study ID: NCT00331760
Study Description
Brief Summary: RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), 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 cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.
Detailed Description: OBJECTIVES: * Determine the transportability of intensity modulated radiotherapy (IMRT) to a multi-institutional setting in patients with resected endometrial or cervical cancer. * Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus standard treatments. * Assess adverse events related to this regimen. * Estimate the rates of local-regional control, distant metastasis, and disease-free and overall survival. * Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma. OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer). All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years. PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Auburn Radiation Oncology, Auburn, California, United States
Radiation Oncology Centers - Cameron Park, Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, United States
East Bay Radiation Oncology Center, Castro Valley, California, United States
Eden Medical Center, Castro Valley, California, United States
Valley Medical Oncology Consultants - Castro Valley, Castro Valley, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Valley Medical Oncology, Fremont, California, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
Highland General Hospital, Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States
Bay Area Breast Surgeons, Incorporated, Oakland, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Larry G Strieff MD Medical Corporation, Oakland, California, United States
Tom K Lee, Incorporated, Oakland, California, United States
Valley Care Medical Center, Pleasanton, California, United States
Valley Medical Oncology Consultants - Pleasanton, Pleasanton, California, United States
Radiation Oncology Center - Roseville, Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States
Mercy General Hospital, Sacramento, California, United States
Veterans Affairs Medical Center - San Diego, San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Doctors Medical Center - San Pablo Campus, San Pablo, California, United States
Solano Radiation Oncology Center, Vacaville, California, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Bay Medical, Panama City, Florida, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Alexian Brothers Radiation Oncology, Elk Grove Village, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex, Hopedale, Illinois, United States
McDonough District Hospital, Macomb, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields, Olympia Fields, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
St. Margaret's Hospital, Spring Valley, Illinois, United States
Valley Cancer Center, Spring Valley, Illinois, United States
Cancer Institute at St. John's Hospital, Springfield, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States
Oncology Center at Saint Margaret Mercy Healthcare Center, Hammond, Indiana, United States
Reid Hospital & Health Care Services, Richmond, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Providence Medical Center, Kansas City, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Menorah Medical Center, Overland Park, Kansas, United States
Johnson County Radiation Therapy, Overland Park, Kansas, United States
Shawnee Mission Medical Center, Shawnee Mission, Kansas, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center, Lewiston, Maine, United States
Union Hospital Cancer Program at Union Hospital, Elkton, Maryland, United States
Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, United States
South Suburban Oncology Center, Quincy, Massachusetts, United States
South Shore Hospital, South Weymouth, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Cancer Institute of Cape Girardeau, LLC, Cape Girardeau, Missouri, United States
Independence Regional Health Center, Independence, Missouri, United States
Truman Medical Center - Hospital Hill, Kansas City, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City, Missouri, United States
Kansas City Cancer Center at St. Joseph's Medical Mall, Kansas City, Missouri, United States
St. Joseph Medical Center, Kansas City, Missouri, United States
North Kansas City Hospital, Kansas City, Missouri, United States
Parvin Radiation Oncology, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center, Kansas City, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden, Camden, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
Lovelace Medical Center - Downtown, Albuquerque, New Mexico, United States
Radiation Oncology Associates, PA, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Cancer Institute of New Mexico, Santa Fe, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Beth Israel Medical Center - Petrie Division, New York, New York, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division, New York, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Huron Hospital Cancer Care Center, Cleveland, Ohio, United States
Euclid Hospital, Cleveland, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Middletown Regional Hospital, Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
South Pointe Hospital Cancer Care Center, Warrensville Heights, Ohio, United States
Clinton Memorial Hospital, Wilmington, Ohio, United States
Cancer Treatment Center, Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania, United States
CCOP - Main Line Health, Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
American Fork Hospital, American Fork, Utah, United States
Sandra L. Maxwell Cancer Center, Cedar City, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo, Provo, Utah, United States
Dixie Regional Medical Center - East Campus, Saint George, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health, Norton, Virginia, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin, United States
Columbia-Saint Mary's Cancer Care Center, Milwaukee, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau, Wisconsin, United States
Princess Margaret Hospital, Toronto, Ontario, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Contact Details
Name: Anuja Jhingran, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
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