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RTOG 0118 Protocol Information

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A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (Nsc# 66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases
Protocol Documents
Current Version Date: 10/31/2003
Principal Investigator: Jonathan Knisely, M.D., FRCPC
Primary Objective:

To compare overall survival of patients treated with orally administered thalidomide starting concomitantly with conventional RT to conventional RT alone;

Patient Population:

 

  • Histopathologically-confirmed extracranial primary malignancy
  • Multiple (>3) brain metastases or a lesser number of metastases with at least one metastasis > 4.0 cm in diameter or metastases to the midbrain or brainstem (radiosurgery ineligible) demonstrated on a contrast-enhanced MRI scan of the brain
  • No chemotherapy within 2 weeks prior to study entry
  • No prior radiation therapy to head and neck area or previous radiosurgery
  • No prior treatment with thalidomide
  • Estimated survival of at least 8 weeks
  • Zubrod 0-1
  • Absolute neutrophil count >/= 1500, Hgb >/=11, platelets >/= 100,000, BUN </= 25, Creatinine </= 1.5, Bilirubin </= 1.5, ALT </=2 x normal range
  • No history of deep venous thrombosis; no current anticoagulant therapy
  • If present, sensory neuropathy must be </= grade 1
  • No medical illnesses or psychiatric impairments which would prevent completion of protocol therapy
  • No pediatric cases
  • Not pregnant, not breast feeding, and willing to comply with contraception guidelines
  • Patients must sign study-specific consent form prior to study entry.

 

Target Accrual: 332
Current Accrual: 183
Status: Terminated
Date: 2/19/2009
Participating Sites:
21st Century Oncology Ft. Myers FL
Advocate Good Samaritan Hospital Downers Grove IL
Advocate Good Shepherd Hospital Barrington IL
Advocate Illinois Masonic Medical Center Chicago IL
Advocate Lutheran General Hospital Park Ridge IL
Allegheny General Hospital Pittsburgh PA
Allegheny Valley Hospital Natrona Heights PA
Alta Bates Summit Medical Center-Herrick Campus Berkeley CA
AMITA Health Alexian Brothers Medical Center Elk Grove Village IL
Arizona Oncology Services Foundation Scottsdale AZ
Arlington Cancer Center Arlington TX
Aultman Health Foundation Canton OH
Baptist Cancer Institute Jacksonville FL
Baptist Health Lexington Lexington KY
Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville KY
Bay Area Medical Center Marinette WI
Bay Area Tumor Institute Oakland CA
Bay Medical Center Panama City FL
Boston Medical Center Boston MA
California Pacific Medical Center-Pacific Campus San Francisco CA
Cancer Treatment Center Wooster OH
Cape Cod Hospital Hyannis MA
Cape Radiation Oncology Cape Girardeau MO
Caritas Regional Cancer Center Louisville KY
Case Western Reserve University Cleveland OH
Champlain Valley Physicians Hospital Medical Center Plattsburgh NY
Christiana Care Health System-Christiana Hospital Newark DE
City of Hope Comprehensive Cancer Center Duarte CA
Cleveland Clinic Foundation Cleveland OH
Clifton Springs Hospital and Clinic Clifton Springs NY
Colorado Cancer Research Program CCOP Denver CO
Community Medical Center Toms River NJ
Community Memorial Hospital Menomonee Falls WI
Cottonwood Hospital Medical Center Murray UT
Covenant Medical Center-Lakeside Lubbock TX
Cross Cancer Institute Edmonton, Alberta
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center Lebanon NH
Dayton CCOP Kettering OH
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Center Regional Cancer Center East St. George UT
East Carolina University Greenville NC
East Bay Radiation Oncology Center Castro Valley CA
Einstein Medical Center Philadelphia Philadelphia PA
Emory University Hospital/Winship Cancer Institute Atlanta GA
Faxton-Saint Luke's Healthcare Utica NY
Fox Chase Cancer Center Philadelphia PA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Geisinger Medical Center Danville PA
Geisinger Wyoming Valley/Henry Cancer Center Wilkes Barre PA
Greater Baltimore Medical Center Baltimore MD
Green Bay Oncology at Saint Vincent Hospital Green Bay WI
Greenville Health System Cancer Institute-Eastside Greenville SC
Gulf Coast Cancer Treatment Center Panama City FL
Gundersen Lutheran Medical Center La Crosse WI
Harbin Clinic Rome GA
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Hines Veterans Administration Hospital Hines IL
Holy Family Memorial Hospital Manitowoc WI
Huntington Memorial Hospital Pasadena CA
Huntsman Cancer Institute/University of Utah Salt Lake City UT
Indiana University Health Bloomington Bloomington IN
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis IN
Ingalls Memorial Hospital Harvey IL
Inspira Medical Center Vineland Vineland NJ
Intercommunity Cancer Center Monroeville PA
IU Health Ball Memorial Hospital Muncie IN
Jackson-Madison County General Hospital Jackson TN
John B Amos Cancer Center Columbus GA
John F Kennedy Medical Center Edison NJ
Johnson City Medical Center Johnson City TN
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Lake University Ireland Cancer Center Mentor OH
Lankenau Medical Center Wynnewood PA
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Lexington Clinic Cancer Center Lexington KY
Liberty Hospital Liberty MO
London Regional Cancer Program London Ontario
Loyola University Medical Center Maywood IL
Mainline Health CCOP Wynnewood PA
Massachusetts General Hospital Cancer Center Boston MA
McKay-Dee Hospital Center Ogden UT
McLaren Cancer Institute-Flint Flint MI
Methodist Medical Center of Illinois Peoria IL
Metro-Minnesota CCOP St. Louis Park MN
Miami Valley Hospital Dayton OH
MidMichigan Medical Center - Alpena Alpena MI
Mills-Peninsula Medical Center San Mateo CA
Missouri Valley Cancer Consortium Omaha NE
Mobile Infirmary Medical Center Mobile AL
Monmouth Medical Center Long Branch NJ
Montgomery Cancer Center, LLC Montgomery AL
Mount Sinai Medical Center Miami Beach FL
Naval Medical Center - Portsmouth Portsmouth VA
Nebraska Methodist Hospital Omaha NE
Nevada Cancer Research Foundation CCOP Las Vegas NV
Newark Beth Israel Medical Center Newark NJ
North Shore-LIJ Health System CCOP Manhasset NY
Northern Indiana Cancer Research Consortium South Bend IN
Northridge Hospital Medical Center Northridge CA
Novant Health Forsyth Medical Center Winston Salem NC
Ochsner Medical Center Jefferson New Orleans LA
Oncology Institute of Greater Lafayette Lafayette IN
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Pocono Medical Center East Strousburg PA
Pomona Valley Hospital Medical Center Pomona CA
Porter Adventist Hospital Denver CO
Pottstown Hospital Pottstown PA
Pottstown Scanning & Treatment Center Pottstown PA
ProHealth Oconomowoc Memorial Hospital Oconomowoc WI
ProHealth Waukesha Memorial Hospital Waukesha WI
Providence Holy Cross Medical Center Mission Hills CA
Providence St. Joseph Medical Center - Disney Family CA Ctr Burbank CA
Rapid City Regional Hospital Rapid City SD
Reading Hospital Reading PA
Regional Hospital of Scranton Scranton PA
Rex Cancer Center Raleigh NC
Richard L. Roudebush VA Medical Center Indianapolis IN
Rochester General Hospital Rochester NY
Saint Agnes Hospital Baltimore MD
Saint Alphonsus Cancer Care Center-Boise Boise ID
Saint Francis Medical Center Cape Girardeau MO
Saint Francis Medical Center Trenton NJ
Saint Joseph Regional Medical Center-Mishawaka Mishawaka IN
Saint Louis University Hospital St. Louis MO
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
SCL Health Saint Joseph Hospital Denver CO
Scottsdale Radiation Oncology Centers-Osborn Center Scottsdale AZ
Sequoia Regional Cancer Center Visalia CA
Sibley Memorial Hospital Washington DC
South Suburban Oncology Center Quincy MA
Southeast Cancer Control Consortium CCOP Winston Salem NC
Sparrow Hospital Lansing MI
St Joseph's Hospital Medical Center Stockton CA
St. Anthony Cancer Care Institute at St. Anthony Hospital Oklahoma City OK
State University of New York Downstate Medical Center Brooklyn NY
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Sutter Cancer Research Consortium Novato CA
The James Graham Brown Cancer Center at University of Louisville Louisville KY
The Toledo Hospital/Toledo Children's Hospital Toledo OH
Thedacare Cancer Institute Appleton WI
Thomas Jefferson University Hospital Philadelphia PA
Toledo Community Hospital Oncology Program CCOP Toledo OH
Tom Baker Cancer Centre Calgary, Alberta
Torrance Memorial Medical Center Torrance CA
Trinity Cancer Care Center Minot ND
Trinity's Tony Teramana Cancer Center Steubenville OH
UCHealth Memorial Hospital Central Colorado Springs CO
UH Seidman Cancer Center at Salem Regional Medical Center Salem OH
UHHS-Chagrin Highlands Medical Center Orange Village OH
UHHS-Westlake Medical Center Westlake OH
Union Hospital Terre Haute IN
United Hospital St. Paul MN
University of Alabama at Birmingham Cancer Center Birmingham AL
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Cincinnati/Barrett Cancer Center Cincinnati OH
University of Colorado Hospital Aurora CO
University of Florida Health Science Center - Gainesville Gainesville FL
University of Florida Health Science Center - Jacksonville Jacksonville FL
University of Kentucky/Markey Cancer Center Lexington KY
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Missouri - Ellis Fischel Columbia MO
University of Rochester Rochester NY
University of Texas Medical Branch Galveston TX
University of Washington Medical Center Seattle WA
University of Wisconsin Hospital and Clinics Madison WI
UP Health System Marquette Marquette MI
UPMC-Magee Womens Hospital Pittsburgh PA
UPMC-Mercy Hospital Pittsburgh PA
UPMC-Passavant Hospital Pittsburgh PA
UPMC-Presbyterian Hospital Pittsburgh PA
UPMC-Shadyside Hospital Pittsburgh PA
Upstate Carolina CCOP Spartanburg SC
USC / Norris Comprehensive Cancer Center Los Angeles CA
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Veterans Administration New Jersey Health Care System East Orange NJ
Virginia Mason CCOP Seattle WA
Virginia Mason Medical Center Seattle WA
Virtua Memorial Mount Holly NJ
Wake Forest University Health Sciences Winston-Salem NC
Wayne State University/Karmanos Cancer Institute Detroit MI
WellSpan Health-York Hospital York PA
West Penn Hospital Pittsburgh PA
Western Oncology Research Consortium Portland OR
Wheaton Franciscan Cancer Care-All Saints Racine WI
Yale University New Haven CT
Updated: 4/8/2011

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