Spots Global Cancer Trial Database for Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
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Trial Identification
Brief Title: Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
Official Title: Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
Study ID: NCT01055197
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer. PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * To compare the 1-year overall median survival rate in patients with extensive stage small cell lung cancer treated with prophylactic cranial irradiation with vs without consolidative extracranial radiotherapy following platinum-based chemotherapy. Secondary * To compare treatment-related adverse events in these patients. * To evaluate patterns of failure in these patients. * To compare the time to first failure in these patients. * To evaluate the percentage of the planned radiotherapy dose given to each site. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment (complete response vs partial response) and number of metastatic lesions (1 vs 2-3). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks. * Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also undergo consolidative extracranial radiotherapy to locoregional and residual metastatic disease 5 days per week for 2-3 weeks. After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and 12 months; every 6 months for 2 years; and then annually thereafter.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology - Tucson, Tucson, Arizona, United States
Saint Agnes Cancer Center at Saint Agnes Medical Center, Fresno, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
Poudre Valley Radiation Oncology, Fort Collins, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus, New Britain, Connecticut, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Integrated Community Oncology Network, Jacksonville Beach, Florida, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States
Integrated Community Oncology Network at Southside Cancer Center, Jacksonville, Florida, United States
Baptist Medical Center South, Jacksonville, Florida, United States
Integrated Community Oncology Network - Orange Park, Orange Park, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, United States
M.D. Anderson Cancer Center at Orlando, Orlando, Florida, United States
Florida Cancer Center - Palatka, Palatka, Florida, United States
Flagler Cancer Center, Saint Augustine, Florida, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital, Atlanta, Georgia, United States
Emory Crawford Long Hospital, Atlanta, Georgia, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Cancer Institute at St. John's Hospital, Springfield, Illinois, United States
Saint John's Cancer Center at Saint John's Medical Center, Anderson, Indiana, United States
Radiation Oncology Associates Southwest, Fort Wayne, Indiana, United States
Parkview Regional Cancer Center at Parkview Health, Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen General Hospital, Goshen, Indiana, United States
Community Regional Cancer Care at Community Hospital East, Indianapolis, Indiana, United States
Community Regional Cancer Care at Community Hospital North, Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Kansas City Cancer Centers - Southwest, Overland Park, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States
James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, United States
St. Agnes Hospital Cancer Center, Baltimore, Maryland, United States
Boston University Cancer Research Center, Boston, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States
Henry Ford Macomb Hospital, Clinton Township, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Cancer Institute of Cape Girardeau, LLC, Cape Girardeau, Missouri, United States
Kansas City Cancer Centers - South, Kansas City, Missouri, United States
Kansas City Cancer Centers - North, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
Barnes-Jewish West County Hospital, Saint Louis, Missouri, United States
Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
Nebraska Medical Center, Omaha, Nebraska, United States
Renown Institute for Cancer at Renown Regional Medical Center, Reno, Nevada, United States
Elliot Regional Cancer Center at Elliot Hospital, Manchester, New Hampshire, United States
Frederick R. and Betty M. Smith Cancer Treatment Center, Sparta, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care, Albany, New York, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
Highland Hospital of Rochester, Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Forsyth Regional Cancer Center at Forsyth Medical Center, Winston-Salem, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Trinity CancerCare Center, Minot, North Dakota, 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
Barberton Citizens Hospital, Barberton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights, Ohio, United States
Lake/University Ireland Cancer Center, Mentor, Ohio, United States
Southwest General Health Center, Middleburg Heights, Ohio, United States
UHHS Chagrin Highlands Medical Center, Orange Village, Ohio, United States
St. Charles Mercy Hospital, Oregon, Ohio, United States
Parma Community General Hospital, Parma, Ohio, United States
North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States
Flower Hospital Cancer Center, Sylvania, Ohio, United States
St. Anne Mercy Hospital, Toledo, Ohio, United States
UHHS Westlake Medical Center, Westlake, Ohio, United States
Cleveland Clinic - Wooster, Wooster, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Three Rivers Community Hospital, Grants Pass, Oregon, United States
Dubs Cancer Center at Rogue Valley Medical Center, Medford, Oregon, United States
Northeast Radiation Oncology Center, Dunmore, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Texas Oncology, PA at Texas Cancer Center - Arlington South, Arlington, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Denton South, Denton, Texas, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital, Fort Worth, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Memorial Hermann Hospital - Memorial City, Houston, Texas, United States
Longview Cancer Center, Longview, Texas, United States
Cancer Care Centers of South Texas - Northeast, San Antonio, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Sherman, Sherman, Texas, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land, Sugar Land, Texas, United States
Tyler Cancer Center, Tyler, Texas, United States
Texas Oncology, PA - Wichita Falls, Wichita Falls, Texas, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee, Milwaukee, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare, Racine, Wisconsin, United States
Riverview UW Cancer Center at Riverview Hospital, Wisconsin Rapids, Wisconsin, United States
British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Rabin Medical Center - Beilinson Campus, Petach Tikva, , Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv, , Israel
Contact Details
Name: Elizabeth M. Gore, MD
Affiliation: Medical College of Wisconsin
Role: PRINCIPAL_INVESTIGATOR
Name: Alexander Sun, MD
Affiliation: Princess Margaret Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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