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RTOG 0913 Protocol Information

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Phase I/II Trial of Concurrent RAD001 (Everolimus) With Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma
Principal Investigator: Prakash Chinnaiyan, MD
Primary Objective:

Phase I: To define the maximum tolerated dose of RAD001 (up to established dose of 10 mg/day) when combined with concurrent radiation and temozolomide in newly diagnosed GBM.

Phase II: To determine the efficacy of RAD001 in combination with radiation and temozolomide followed by RAD001 in combination with temozolomide in patients with newly diagnosed GBM as measured by progression-free survival. 

Patient Population:

Histopathologically proven diagnosis of glioblastoma (WHO Grade IV) confirmed by central pathology review prior to Step 2 registration. Tumor tissue available for correlative studies (PHASE II ONLY)

Target Accrual: 246
Current Accrual: 279
Status: Closed to Accrual
Date: 9/12/2013
Participating Sites:
Abbott Northwestern Hospital Minneapolis MN
ACR Clinical Research Center Philadelphia PA
Adams Cancer Center Gettysburg PA
Akron City Hospital Akron OH
Akron General Medical Center Akron OH
Allegiance Health/W.A. Foote Memorial Hospital Jackson MI
Arizona Oncology - Deer Valley Center Phoenix AZ
Arizona Oncology Services Foundation Scottsdale AZ
Baptist Cancer Institute Jacksonville FL
Bay Area Medical Center Marinette WI
Borgess Medical Center Kalamazoo MI
Brigham and Women's Hospital/Dana Farber Cancer Institute Boston MA
Bronson Methodist Hospital Kalamazoo MI
Cancer Research for the Ozarks CCOP Springfield MO
Cape Radiation Oncology Cape Girardeau MO
Carolina Medical Center-Northeast Concord NC
Carolinas Medical Center/Levine Cancer Institute Charlotte NC
Carolinas Medical Center-Union Monroe NC
Central DuPage Hospital Cancer Center Warrenville IL
Centre Hospitalier de l`Université de Montréal-Notre Dame Montreal Quebec
Cherry Tree Cancer Center Hanover PA
Christiana Care Health Services, Inc. CCOP Newark DE
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland OH
Cleveland Clinic Cancer Center-Independence Independence OH
Cleveland Clinic Foundation Cleveland OH
Cleveland Clinic Foundation- Parma Parma OH
Cleveland Clinic Wooster Specialty Center Wooster OH
Cleveland Clinic-Strongsville Strongsville OH
Cox Health System Springfield MO
D.N. Greenwald Mukwonago WI
Dixie Medical Cancer Center East St. George UT
Door County Cancer Center Sturgeon Bay WI
Emory University Atlanta GA
Emory University Hospital Midtown Atlanta GA
Enloe Medical Center Chico CA
Fairview Ridges Hospital Burnsville MN
Fairview Southdale Hospital Edina MN
Florida Hospital Orlando FL
Forsyth Regional Medical Center Winston Salem NC
Fox Chase Virtua Health Cancer Treatment Center Voorhees NJ
Genesys Regional Medical Center Flint MI
Good Samaritan Health Systems Kearney NE
Green Bay Oncology at St. Vincent Hospital Green Bay WI
Greenville Health System Cancer Institute-Faris Greenville SC
Greenville Health System Cancer Institute-Greer Radiation Greer SC
Greenville Health System Cancer Institute-International Greenville SC
Greenville Health System Cancer Institute-Seneca Seneca SC
H. Lee Moffitt Cancer Center & Research Institute Tampa FL
Heartland Regional Medical Center St. Joseph MO
Hematology-Oncology Associates of CNY CCOP East Syracuse NY
Hennepin County Medical Center Minneapolis MN
Highland Hospital Rochester NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Hurley Cancer Center Flint MI
ICON – Baptist Medical Center South Jacksonville FL
ICON – Cancer Center of Putnam Palatka FL
ICON – Flagler Cancer Center St Augustine FL
ICON – Florida Cancer Center - Beaches Jacksonville Beach FL
ICON – Orange Park Cancer Center Orange Park FL
ICON – Southside Cancer Center Jacksonville FL
Idaho Urologic Institute Meridian ID
Image-Guided Therapy QA Center (ITC) St. Louis MO
Intermountain Medical Center Murray UT
Jackson Memorial Hospital Miami FL
Joe Arrington Cancer Research & Treatment Center Lubbock TX
John H. Stroger, Jr. Hospital of Cook County MBCCOP Chicago IL
John Muir Medical Center - Concord Campus Concord CA
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Lake/University Seidman Cancer Center Mentor OH
Langlade Hospital Cancer Center Antigo WI
LDS Hospital Salt Lake City UT
Legacy Good Samaritan Hospital & Medical Center Portland OR
Legacy Mount Hood Medical Center Gresham OR
Legacy Salmon Creek Hospital Vancouver WA
Levine Cancer Institute-Pineville Charlotte NC
Liberty Radiation Oncology Clinic Liberty MO
Logan Regional Hospital Logan UT
Loyola University Chicago Maywood IL
Maimonides Medical Center Brooklyn NY
Maine Medical Center Scarborough ME
Maplewood Cancer Center Maplewood MN
Massachusetts General Hospital Boston MA
McGill University Montreal
McKay-Dee Hospital Ogden UT
Medical College of Wisconsin Milwaukee WI
Medical University of South Carolina Charleston SC
Memorial Medical Center Savannah GA
Menorah Medical Center Overland Park KS
Mercy Hospital Coon Rapids MN
Mercy Hospital Port Huron Port Huron MI
Mercy Hospital St. Louis St Louis MO
Mercy-Springfield Springfield MO
Metro-MN CCOP St. Louis Park MN
Michigan Cancer Research Consortium CCOP Ann Arbor MI
Montefiore Medical Center - Moses Campus Bronx NY
North Coast Cancer Care Sandusky OH
North Kansas City Hospital North Kansas City MO
North Memorial Medical Center Robbinsdale MN
Northwest Community Hospital Arlington Heights IL
Northwestern Memorial Hospital Chicago IL
Norton Cancer Institute Louisville KY
Oakwood Healthcare Inc Dearborn MI
Oconomowoc Memorial Hospital - ProHealth Care Inc. Oconomowoc WI
Parkridge University Radiation Oncology Rochester NY
Parkview Cancer Center - Parkview Hospital Fort Wayne IN
Peninsula Regional Medical Center Salisbury MD
Phelps County Regional Medical Center Rolla MO
Piedmont Fayette Hospital Fayetteville GA
Piedmont Hospital Atlanta GA
Poudre Valley Hospital Radiation Oncology Fort Collins CO
Presbyterian Hospital Charlotte NC
Radiation Oncology Associates Fort Wayne IN
Radiation Oncology Center of Walnut Creek - John Muir Med Ct Concord CA
Reading Hospital Reading PA
Regions Radiation Therapy St. Paul MN
Research Medical Center Kansas City MO
Rhode Island Hospital Providence RI
Rice Memorial Hospital Willmar MN
Ridgeview Medical Center Waconia MN
Rock Hill Radiation Therapy Center Rock HIll SC
Rutgers, The State University of New Jersey New Brunswick NJ
Saint Alphonsus Regional Medical Center Boise ID
Saint Barnabas Medical Center Livingston NJ
Sands Cancer Center Canandaigua NY
Sparrow Regional Cancer Center Lansing MI
St Francis Hospital & Medical Center Hartford CT
St Luke's Hospital Kansas City MO
St Mary's Hospital & Medical Center Grand Junction CO
St. Agnes Healthcare Baltimore MD
St. Johns Hospital & Medical Center Grosse Pointe Woods MI
St. Joseph Hospital Orange CA
St. Joseph Mercy Hospital Ann Arbor MI
St. Joseph Mercy Oakland Pontac MI
St. Lukes Hospital Bethlehem PA
St. Mary Mercy Hospital Livonia MI
St. Mary`s Medical Center Saginaw MI
St. Mary's Hospital Medical Center Green Bay WI
St. Vincent Hospital and Health Care Centers, Inc. Indianapolis IN
St. Vincent Regional Cancer Center CCOP Green Bay WI
Summa Health Center at Lake Medina Medina OH
Summa Health System Barberton Hospital Barberton OH
Tel-Aviv Sourasky Medical Center Tel-Aviv
Texas Oncology - Austin Midtown Austin TX
Texas Oncology - Central South Austin Austin TX
Texas Oncology - Round Rock Cancer Center Round Rock TX
Texas Oncology - Seton Williamson Round Rock TX
Texas Oncology - South Austin Austin TX
The Hospital of Central Connecticut New Britain CT
The Methodist Hospital Houston TX
The Norton Cancer Institute - Downtown Louisville KY
The Ottawa Hospital Regional Cancer Centre Ottawa, Ontario
The Regional Cancer Center at Singing River Hospital System Pascagoula MS
The Schiffler Cancer Center Wheeling WV
Thomas Jefferson University Hospital Philadelphia PA
UH Seidman Cancer Center at Geauga Medical Center Chardon OH
UH Seidman Cancer Center at Southwest General Middleburgh OH
UHHS - Westlake Medical Center Westlake OH
United Hospital St. Paul MN
Unity Hospital Fridley MN
Univ of Kansas Comprehensive Cancer Center Kansas City KS
Univ. of Miami Sylvester Comp Cancer Ctr-Deerfield Beach Deerfield Beach FL
University Hospitals of Cleveland Cleveland OH
University of Chicago Chicago IL
University of Colorado Denver Aurora CO
University of Florida College of Medicine Gainesville FL
University of Kansas Cancer Center - Southwest Overland Park KS
University of Kansas Cancer Center-East Lee's Summit MO
University of Kansas Cancer Center-North Kansas City MO
University of Kansas Cancer Center-South Kansas City MO
University of Maryland Medical Systems Baltimore MD
University of Miami Miller School of Medicine Miami FL
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Rochester Rochester NY
University of Texas at San Antonio San Antonio TX
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 Hospital Madison WI
USON- New York Oncology Hematology, P.C. Albany NY
USON- Texas Oncology Longview Cancer Center Longview TX
USON- Texas Oncology-Tyler Tyler TX
USON-Cancer Care Northwest - Spokane Spokane WA
USON-Cancer Care Northwest-East Holland Spokane WA
USON-Fort Worth Fort Worth TX
USON-Texas Oncology - Houston Memorial City Houston TX
USON-Williamette Valley Cancer Center Eugene OR
Utah Cancer Specialists Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Virginia Commonwealth University Richmond VA
Virtua-Memorial Hospital Burlington County, Inc. Mount Holly NJ
Waukesha Memorial Hospital Waukesha WI
Wausau Hospital Center Wausau WI
Webber Cancer Center Warren MI
York Cancer Center York PA
Updated: 3/17/2014

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