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RTOG 0320 Protocol Information

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A Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases
Protocol Documents
Current Version Date: 8/4/2011
Principal Investigator: Paul W. Sperduto, MD, MAPP
Primary Objective:

To determine if either temozolomide or erlotinib combined with WBRT and SRS improves survival compared to WBRT and SRS alone.

Patient Population:

Histologically confirmed non-small cell lung cancer with 1-3 intraparenchymal brain metastases. Well-circumscribed intraparenchymal brain lesion with maximum tumor diameter (</=4.0 cm per lesion). If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0 cm in maximum diameter. Patients who have undergone subtotal resection are eligible providing residual disease is </=4.0 cm in maximum diameter. No metastases to brain stem, midbrain, pons, medulla or within 10 mm of the optic apparatus (optic nerves and chiasm). No clinical or radiographic evidence of progression of extracranial disease in the month prior to randomization. (Patients who present with symptoms of brain metastases at the time of initial diagnosis are eligible and do not need to demonstrate one month of stable scans.)

Target Accrual: 381
Current Accrual: 126
Status: Terminated
Date: 11/5/2013
Participating Sites:
21st Century Oncology-Orange Park Orange Park FL
21st Century Oncology-Palatka Palatka FL
Abbott-Northwestern Hospital Minneapolis MN
Abington Memorial Hospital Abington PA
Arizona Oncology Services Foundation Scottsdale AZ
Arlington Cancer Center Arlington TX
Atrium Medical Center-Middletown Regional Hospital Franklin OH
Baptist Cancer Institute Jacksonville FL
Baptist Medical Center South Jacksonville FL
Bay Medical Center Panama City FL
Beth Israel Deaconess Medical Center Boston MA
Borgess Medical Center Kalamazoo MI
Brigham and Women's Hospital Boston MA
Bronson Methodist Hospital Kalamazoo MI
Bryn Mawr Hospital Bryn Mawr PA
Cancer Care Manitoba Foundation Winnipeg, Manitoba
Cape Radiation Oncology Cape Girardeau MO
Christiana Care Health System-Christiana Hospital Newark DE
City of Hope Comprehensive Cancer Center Duarte CA
Cleveland Clinic Foundation Cleveland OH
Coborn Cancer Center at Saint Cloud Hospital St. Cloud MN
Community Cancer Center Foundation Normal IL
Community Howard Regional Health Kokomo IN
Community Medical Center Toms River NJ
Cottonwood Hospital Medical Center Murray UT
Covenant Medical Center-Lakeside Lubbock TX
CoxHealth South Hospital Springfield MO
Dayton CCOP Kettering OH
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Center Regional Cancer Center East St. George UT
Einstein Medical Center Philadelphia Philadelphia PA
Elkhart General Hospital Elkhart IN
Emory University Hospital Midtown Atlanta GA
Emory University Hospital/Winship Cancer Institute Atlanta GA
EvergreenHealth Medical Center Kirkland WA
Fairview Ridges Hospital Burnsville MN
Fairview-Southdale Hospital Edina MN
Finley Hospital Dubuque IA
Fox Chase Cancer Center Philadelphia PA
Franciscan Saint Francis Health-Beech Grove Beech Grove IN
Franciscan St. Margaret Health Hammond IN
Froedtert and the Medical College of Wisconsin Milwaukee WI
Good Samaritan Hospital - Dayton Dayton OH
Grady Health System Atlanta GA
Grandview Hospital Dayton OH
Greene Memorial Hospital Xenia OH
Gulf Coast Cancer Treatment Center Panama City FL
Gundersen Lutheran Medical Center La Crosse WI
Hennepin County Medical Center Minneapolis MN
Highland Hospital Rochester NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Holy Cross Hospital Fort Lauderdale FL
Holy Family Memorial Hospital Manitowoc WI
Illinois CancerCare-Peoria Peoria IL
Indiana University Health Ball Memorial Hospital, Inc. Muncie IN
Indiana University Health Methodist Hospital Indianapolis IN
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis IN
Ingalls Memorial Hospital Harvey IL
Ingalls Memorial Hospital-Tinley Campus Tinley Park IL
Integrated Community Oncology Network-Flager Cancer Center St Augustine FL
Integrated Community Oncology Network-Florida Cancer Center Beaches Jacksonville Beach FL
Integrated Community Oncology Network-Southside Cancer Center Jacksonville FL
Intermountain Medical Center Murray UT
IU Health La Porte Hospital La Porte IN
John B Amos Cancer Center Columbus GA
Jupiter Medical Center Jupiter FL
Kaiser Permanente Los Angeles Medical Center Los Angeles CA
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Kettering Medical Center Dayton OH
Lakeland Hospital St Joseph MI
Lakeland Regional Health System St. Joseph MI
Lankenau Medical Center Wynnewood PA
LDS Hospital Salt Lake City UT
Liberty Hospital Liberty MO
M D Anderson Cancer Center Houston TX
Mainline Health CCOP Wynnewood PA
Massachusetts General Hospital Boston MA
McGill University Department of Oncology Montreal
McKay-Dee Hospital Center Ogden UT
McLaren Cancer Institute - Flint Flint MI
Medical University of South Carolina Charleston SC
Memorial Hospital South Bend IN
Mercy Hospital Coon Rapids MN
Mercy Hospital Saint Louis St Louis MO
Mercy Hospital Springfield Springfield MO
Methodist Hospital Philadelphia PA
Methodist Medical Center of Illinois Peoria IL
Metro-Minnesota CCOP St. Louis Park MN
Miami Valley Hospital Dayton OH
Minnesota Oncology Hematology PA-Maplewood Maplewood MN
Mission Hospital-Memorial Campus Asheville NC
Mobile Infirmary Medical Center Mobile AL
Mount Sinai Medical Center Miami Beach FL
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa OK
Nevada Cancer Research Foundation CCOP Las Vegas NV
North Memorial Medical Health Center Robbinsdale MN
North Shore-LIJ Health System CCOP Manhasset NY
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima WA
Northeast Radiation Oncology Center Dunmore PA
Northern Indiana Cancer Research Consortium South Bend IN
Northridge Hospital Medical Center Northridge CA
Northwest Community Hospital Arlington Heights IL
Northwestern University Chicago IL
Norton Suburban Hospital and Medical Campus Louisville KY
Oregon Health and Science University Portland OR
OSF Saint Francis Medical Center Peoria IL
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin IL
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria IL
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Paoli Memorial Hospital Paoli PA
Parkview Hospital Randallia Fort Wayne IN
Pomona Valley Hospital Medical Center Pomona CA
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
Radiation Oncology Associates PC Fort Wayne IN
Reading Hospital Reading PA
Regions Hospital St. Paul MN
Renown Regional Medical Center Reno NV
Rice Memorial Hospital Willmar MN
Riddle Memorial Hospital Media PA
Ridgeview Medical Center Waconia MN
Riverview Medical Center/Booker Cancer Center Red Bank NJ
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick NJ
Saint Agnes Hospital Baltimore MD
Saint Alphonsus Cancer Care Center-Boise Boise ID
Saint Francis Hospital Federal Way WA
Saint John's Hospital - Healtheast Maplewood MN
Saint Joseph Regional Medical Center South Bend In
Saint Mary's Hospital and Regional Medical Center Grand Junction CO
Sandra L Maxwell Cancer Center Cedar City UT
Santa Monica Cancer Treatment Center Inglewood CA
Scottsdale Radiation Oncology Centers-Osborn Center Scottsdale AZ
Scottsdale Radiation Oncology Centers-Shea Center Scottsdale AZ
Sentara Norfolk General Hospital Norfolk VA
South Nassau Communities Oceanside NY
South Suburban Oncology Center Quincy MA
Southeast Missouri Hospital Cape Girardeau MO
Sparta Cancer Center Sparta NJ
St Johns Hospital, Cancer Institute Springfield IL
St. Anthony's Health Alton IL
St. Louis University Hospital St. Louis MO
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Summa Barberton Hospital Barberton OH
Tallahassee Memorial HealthCare Tallahassee FL
Tel-Aviv Sourasky Medical Center Tel-Aviv
The Cancer Center for Southern Kentucky Bowling Green KY
The James Graham Brown Cancer Center at University of Louisville Louisville KY
The Ottawa Hospital Regional Cancer Centre Ottawa, Ontario
The Research Institute of the McGill University Health Centr Montreal
Thomas Jefferson University Hospital Philadelphia PA
Thompson Cancer Survival Center Knoxville TN
Tom Baker Cancer Centre Calgary, Alberta
UF Cancer Center at Orlando Health Orlando FL
United Hospital St. Paul MN
Unity Hospital Fridley MN
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Cincinnati/Barrett Cancer Center Cincinnati OH
University of Florida Health Science Center - Gainesville Gainesville FL
University of Florida Health Science Center - Jacksonville Jacksonville FL
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Michigan Comprehensive Cancer Center Ann Arbor MI
University of Minnesota/Masonic Cancer Center Minneapolis MN
University of Rochester Rochester NY
University of Texas Medical Branch Galveston TX
University of Texas Southwestern Medical School Dallas TX
University of Utah Health Science Center Salt Lake City UT
University of Wisconsin Cancer Center Johnson Creek Johnson Creek WI
University of Wisconsin Hospital and Clinics Madison WI
University Pointe-Precision Radiotherapy West Chester OH
Upper Valley Medical Center Troy OH
Utah Cancer Specialists-Salt Lake City Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Veteran Affairs Medical Center Dayton OH
Virginia Commonwealth University/Massey Cancer Center Richmond VA
Virginia Mason CCOP Seattle WA
Virginia Mason Medical Center Seattle WA
Washington Cancer Institute Washington DC
Washington University School of Medicine St. Louis MO
Wayne State University/Karmanos Cancer Institute Detroit MI
Wheaton Franciscan Cancer Care-All Saints Racine WI
William Beaumont Hospital-Royal Oak Royal Oak MI
Updated: 11/8/2013

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