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)
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall survival
No
Elizabeth M. Gore, MD
Principal Investigator
Medical College of Wisconsin
Unspecified
CDR0000663959
NCT01055197
March 2010
Name | Location |
---|---|
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Parma Community General Hospital | Parma, Ohio 44129 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Poudre Valley Radiation Oncology | Fort Collins, Colorado 80528 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta, New Jersey 07871 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
Three Rivers Community Hospital | Grants Pass, Oregon 97527 |
Dubs Cancer Center at Rogue Valley Medical Center | Medford, Oregon 97504 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Baptist Medical Center South | Jascksonville, Florida 32258 |
Florida Cancer Center - Palatka | Palatka, Florida 32177 |
Flagler Cancer Center | Saint Augustine, Florida 32086 |
Tyler Cancer Center | Tyler, Texas 75702 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
Trinity CancerCare Center | Minot, North Dakota 58701 |
Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
Integrated Community Oncology Network - Orange Park | Orange Park, Florida 32073 |
Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta, Georgia 30303 |
Emory Crawford Long Hospital | Atlanta, Georgia 30308 |
New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany, New York 12208 |
Saint John's Cancer Center at Saint John's Medical Center | Anderson, Indiana 46016 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Barnes-Jewish West County Hospital | Saint Louis, Missouri 63141 |
Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |
Community Regional Cancer Care at Community Hospital North | Indianapolis, Indiana 46256 |
Community Regional Cancer Care at Community Hospital East | Indianapolis, Indiana 46219 |
Integrated Community Oncology Network at Southside Cancer Center | Jacksonville, Florida 32207 |
Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
UHHS Chagrin Highlands Medical Center | Orange Villager, Ohio 44122 |
UHHS Westlake Medical Center | Westlaker, Ohio 44145 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
Longview Cancer Center | Longview, Texas 75601 |
Riverview UW Cancer Center at Riverview Hospital | Wisconsin Rapids, Wisconsin 54494 |
Northeast Radiation Oncology Center | Dunmore, Pennsylvania 18512 |
Radiation Oncology Associates Southwest | Fort Wayne, Indiana 46804 |
Henry Ford Macomb Hospital | Clinton Township, Michigan 48038 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Texas Oncology, PA at Texas Cancer Center - Denton South | Denton, Texas 76210 |
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth, Texas 76104 |
Cancer Care Centers of South Texas - Northeast | San Antonio, Texas 78217 |
Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman, Texas 75090 |
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land, Texas 77479 |
Nebraska Medical Center | Omaha, Nebraska 68198 |
Arizona Oncology - Tucson | Tucson, Arizona 85704 |
Kansas City Cancer Centers - South | Kansas City, Missouri 64131 |
Saint Agnes Cancer Center at Saint Agnes Medical Center | Fresno, California 93720 |
Texas Oncology, PA at Texas Cancer Center - Arlington South | Arlington, Texas 76014 |
Memorial Hermann Hospital - Memorial City | Houston, Texas 77024 |
Texas Oncology, PA - Wichita Falls | Wichita Falls, Texas 76310 |