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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:
Adams Cancer Center Gettysburg PA
Akron City Hospital Akron OH
Akron General Medical Center Akron OH
Arizona Oncology - Deer Valley Center Phoenix AZ
Arizona Oncology Services Foundation Scottsdale AZ
Bay Area Medical Center Marinette WI
Borgess Medical Center Kalamazoo MI
Bronson Methodist Hospital Kalamazoo MI
Cancer Research for the Ozarks CCOP Springfield MO
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 Wooster Specialty Center Wooster OH
Cleveland Clinic-Strongsville Strongsville OH
Cox Health System Springfield MO
Dixie Medical Cancer Center East St. George UT
Door County Cancer Center Sturgeon Bay WI
Enloe Medical Center Chico CA
Forsyth Regional Medical Center Winston Salem NC
Genesys Regional Medical Center Flint MI
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
Highland Hospital Rochester NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Hurley Cancer Center Flint MI
Intermountain Medical Center Murray UT
Jackson Memorial Hospital Miami FL
John H. Stroger, Jr. Hospital of Cook County MBCCOP Chicago IL
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Lake/University Seidman Cancer Center Mentor OH
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
Liberty Radiation Oncology Clinic Liberty MO
Logan Regional Hospital Logan UT
Maine Medical Center Scarborough ME
McGill University Montreal
McKay-Dee Hospital Ogden UT
Memorial Medical Center Savannah GA
Menorah Medical Center Overland Park KS
Mercy Hospital Port Huron Port Huron MI
Michigan Cancer Research Consortium CCOP Ann Arbor MI
North Coast Cancer Care Sandusky OH
North Kansas City Hospital North Kansas City MO
Northwestern Memorial Hospital Chicago IL
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
Radiation Oncology Associates Fort Wayne IN
Reading Hospital Reading PA
Research Medical Center Kansas City MO
Rhode Island Hospital Providence RI
Saint Alphonsus Regional Medical Center Boise ID
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 Mercy Hospital Ann Arbor MI
St. Joseph Mercy Oakland Pontac MI
St. Mary Mercy Hospital Livonia MI
St. Mary`s Medical Center Saginaw MI
St. Mary's Hospital Medical Center Green Bay WI
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 Regional Cancer Center at Singing River Hospital System Pascagoula MS
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
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 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 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
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
Waukesha Memorial Hospital Waukesha WI
Webber Cancer Center Warren MI
York Cancer Center York PA
Updated: 3/17/2014

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