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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:
21st Century Oncology-Orange Park Orange Park FL
21st Century Oncology-Palatka Palatka FL
Abbott-Northwestern Hospital Minneapolis MN
ACR Clinical Research Center Philadelphia PA
Adams Cancer Center Gettysburg PA
Akron General Medical Center Akron OH
Allegiance Health Jackson MI
Arizona Oncology Associates-Deer Valley Center Phoenix AZ
Arizona Oncology Services Foundation Scottsdale AZ
Arizona Oncology Services Foundation Phoenix AZ
Baptist Cancer Institute Jacksonville FL
Baptist Medical Center South Jacksonville FL
Bay Area Medical Center Marinette WI
Beaumont Hospital-Dearborn Dearborn MI
Borgess Medical Center Kalamazoo MI
Brigham and Women's Hospital Boston MA
Bronson Methodist Hospital Kalamazoo MI
Cape Radiation Oncology Cape Girardeau MO
Carolinas HealthCare System NorthEast Concord NC
Carolinas HealthCare System Union Monroe NC
Carolinas Medical Center/Levine Cancer Institute Charlotte NC
Case Western Reserve University Cleveland OH
Centre Hospitalier de l`Universite de Montreal-Notre Dame Montreal Quebec
Cherry Tree Cancer Center Hanover PA
CHI Health Good Samaritan Kearney NE
Christiana Care Health System-Christiana Hospital 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
Covenant Medical Center-Lakeside Lubbock TX
CoxHealth South Hospital Springfield MO
Delbert Day Cancer Institute at PCRMC Rolla MO
Dixie Medical Center Regional Cancer Center East St. George UT
Emory University Hospital Midtown Atlanta GA
Emory University Hospital/Winship Cancer Institute Atlanta GA
Enloe Medical Center Chico CA
Fairview Ridges Hospital Burnsville MN
Fairview-Southdale Hospital Edina MN
Florida Hospital Orlando Orlando FL
Froedtert and the Medical College of Wisconsin Milwaukee WI
Genesys Hurley Cancer Institute Flint MI
Green Bay Oncology at Saint Vincent Hospital Green Bay WI
Greenville Health System Cancer Institute-Eastside Greenville SC
Greenville Health System Cancer Institute-Faris Greenville SC
Greenville Health System Cancer Institute-Greer Greer SC
Greenville Health System Cancer Institute-Seneca Seneca SC
Heartland Regional Medical Center St. Joseph MO
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse NY
Hennepin County Medical Center Minneapolis MN
Highland Hospital Rochester NY
Hillcrest Hospital Cancer Center Mayfield Heights OH
Hurley Medical Center Flint MI
Idaho Urologic Institute-Meridian Meridian ID
Image-Guided Therapy QA Center (ITC) St. Louis MO
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
Jackson Memorial Hospital Miami FL
John H Stroger Jr Hospital of Cook County Chicago IL
John Muir Medical Center-Concord Concord CA
John Muir Medical Center-Walnut Creek Concord CA
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Lake Huron Medical Center Port Huron MI
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 Center Liberty MO
Logan Regional Hospital Logan UT
Loyola University Medical Center Maywood IL
Maimonides Medical Center Brooklyn NY
Maine Medical Center- Scarborough Campus Scarborough ME
Massachusetts General Hospital Boston MA
McGill University Department of Oncology Montreal
McKay-Dee Hospital Center Ogden UT
Medical University of South Carolina Charleston SC
Memorial Hermann Memorial City Medical Center Houston TX
Memorial University Medical Center Savannah GA
Menorah Medical Center Overland Park KS
Mercy Hospital Coon Rapids MN
Mercy Hospital Saint Louis St Louis MO
Mercy Hospital Springfield Springfield MO
Metro-Minnesota CCOP St. Louis Park MN
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Minnesota Oncology Hematology PA-Maplewood Maplewood MN
Moffitt Cancer Center Tampa FL
Montefiore Medical Center - Moses Campus Bronx NY
New York Oncology Hematology PC - Albany Albany NY
North Coast Cancer Care Sandusky OH
North Kansas City Hospital North Kansas City MO
North Memorial Medical Health Center Robbinsdale MN
Northwest Community Hospital Arlington Heights IL
Northwestern Medicine Cancer Center Warrenville Warrenville IL
Northwestern University Chicago IL
Norton Hospital Pavilion and Medical Campus Louisville KY
Norton Suburban Hospital and Medical Campus Louisville KY
Novant Health Forsyth Medical Center Winston Salem NC
Novant Health Presbyterian Medical Center Charlotte NC
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Parkridge University Radiation Oncology Rochester NY
Parkview Hospital Randallia Fort Wayne IN
Peninsula Regional Medical Center Salisbury MD
Piedmont Fayette Hospital Fayetteville GA
Piedmont Hospital Atlanta GA
Poudre Valley Hospital Radiation Oncology Fort Collins CO
ProHealth D N Greenwald Center Mukwonago WI
ProHealth Oconomowoc Memorial Hospital Oconomowoc WI
ProHealth Waukesha Memorial Hospital Waukesha WI
Radiation Oncology Associates PC Fort Wayne IN
Reading Hospital Reading PA
Regions Hospital 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 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 Barnabas Medical Center Livingston NJ
Saint John Hospital and Medical Center Grosse Pointe Woods MI
Saint John Macomb-Oakland Hospital Warren MI
Saint Joseph Hospital - Orange Orange CA
Saint Joseph Mercy Hospital Ann Arbor MI
Saint Joseph Mercy Oakland Pontac MI
Saint Luke's Hospital of Kansas City Kansas City MO
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Mary Mercy Hospital Livonia MI
Saint Mary's Hospital and Regional Medical Center Grand Junction CO
Saint Mary's of Michigan Saginaw MI
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay WI
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay WI
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Sands Cancer Center Canandaigua NY
Singing River Hospital Pascagoula MS
Smilow Cancer Hospital Care Center at Saint Francis Hartford CT
Sparrow Hospital Lansing MI
St. Vincent Hospital and Health Care Centers, Inc. Indianapolis IN
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Summa Barberton Hospital Barberton OH
Summa Health Center at Lake Medina Medina OH
Tel-Aviv Sourasky Medical Center Tel-Aviv
Texas Oncology - Central Austin Cancer Center Austin TX
Texas Oncology - Round Rock Cancer Center Round Rock TX
Texas Oncology - South Austin Cancer Center Austin TX
Texas Oncology-Austin Midtown Austin TX
Texas Oncology-Longview Cancer Center Longview TX
Texas Oncology-Seton Williamson Round Rock TX
The Hospital of Central Connecticut New Britain CT
The Klabzuba Cancer Center Fort Worth TX
The Methodist Hospital Houston TX
The Ottawa Hospital Regional Cancer Centre Ottawa, Ontario
The Research Institute of the McGill University Health Centr Montreal
The University of Kansas Cancer Center-Lee's Summit Lee's Summit MO
The University of Kansas Cancer Center-North Kansas City MO
The University of Kansas Cancer Center-South Kansas City MO
Thomas Jefferson University Hospital Philadelphia PA
Tyler Cancer Center Tyler TX
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
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach FL
United Hospital St. Paul MN
Unity Hospital Fridley MN
University of Chicago Comprehensive Cancer Center Chicago IL
University of Colorado Hospital Aurora CO
University of Florida Health Science Center - Gainesville Gainesville FL
University of Kansas Cancer Center Kansas City KS
University of Kansas Cancer Center-Overland Park Overland Park KS
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Oklahoma Health Sciences Center Oklahoma City OK
University of Rochester Rochester NY
University of Texas Health Science Center 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 and Clinics Madison WI
USON-Cancer Care Northwest - Spokane Spokane WA
USON-Cancer Care Northwest-East Holland Spokane WA
USON-Williamette Valley Cancer Center Eugene OR
Utah Cancer Specialists-Salt Lake City Salt Lake City UT
Utah Valley Regional Medical Center Provo UT
Virginia Commonwealth University/Massey Cancer Center Richmond VA
Virtua Memorial Mount Holly NJ
Virtua Voorhees Voorhees NJ
Wausau Hospital Center Wausau WI
WellSpan Health-York Hospital York PA
Wheeling Hospital/Schiffler Cancer Center Wheeling WV
Updated: 3/2/2015

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