Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

Who is this study for? Patients with Glioblastoma, Gliosarcoma
Status: Active, not recruiting
Location: See all (240) locations...
Intervention Type: Other, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• PRIOR TO STEP 1 REGISTRATION

• A diagnostic contrast-enhanced magnetic resonance imaging (MRI) (no other scan type allowed) of the brain must be performed postoperatively within 72 hours of resection; the enhancing tumor must have a maximal diameter of 5 cm; the tumor diameter will be the greatest diameter as measured on the contrast-enhanced postoperative MRI and will include residual disease and/or the postoperative surgical cavity as appropriate; for cases where residual disease or postoperative surgical cavity is NOT identifiable (e.g., polar glioblastomas [GBMs] where a polar lobectomy is performed), the patient will be excluded from the trial

• The GBM tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)

• Patients must provide study-specific informed consent prior to step 1 registration

• PRIOR TO STEP 2 REGISTRATION

• Histologically proven diagnosis of glioblastoma (World Health Organization [WHO] grade IV) confirmed by central review prior to step 2 registration

• Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient quantity for analysis of O6-methylguanin-DNA-methyltransferase (MGMT) status

• Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged to maximize the chances of eligibility; at least 1 cubic centimeter of tissue composed primarily of tumor must be present

• Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy or cavitron ultrasonic suction aspirator (CUSA) technique are not allowed

• History/physical examination within 28 days prior to step 2 registration

• The patient must have recovered from effects of surgery, postoperative infection, and other complications within 28 days prior to step 2 registration

• Documentation of steroid doses within 28 days prior to step 2 registration

• Karnofsky performance status >= 70 within 28 days prior to step 2 registration

• Age >= 18

• Absolute neutrophil count (ANC) >= 1,800 cells/mm^3

• Platelets >= 100,000 cells/mm^3

• Hemoglobin >= 10.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)

• Bilirubin =< 1.5 upper limit of normal (ULN)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN

• Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Arizona
Mayo Clinic Hospital in Arizona
Phoenix
Saint Joseph's Hospital and Medical Center
Phoenix
Mayo Clinic in Arizona
Scottsdale
Arizona Oncology Associates-West Orange Grove
Tucson
Banner University Medical Center - Tucson
Tucson
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
Eden Hospital Medical Center
Castro Valley
Fresno Cancer Center
Fresno
Marin General Hospital
Greenbrae
Loma Linda University Medical Center
Loma Linda
Cedars Sinai Medical Center
Los Angeles
Los Angeles County-USC Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
Fremont - Rideout Cancer Center
Marysville
Memorial Medical Center
Modesto
Kaiser Permanente Oakland-Broadway
Oakland
Saint Joseph Hospital - Orange
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
Palo Alto Medical Foundation Health Care
Palo Alto
Pomona Valley Hospital Medical Center
Pomona
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova
Rohnert Park Cancer Center
Rohnert Park
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Roseville
South Sacramento Cancer Center
Sacramento
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
California Pacific Medical Center-Pacific Campus
San Francisco
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz
Kaiser Permanente Cancer Treatment Center
South San Francisco
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville
John Muir Medical Center-Walnut Creek
Walnut Creek
Colorado
UCHealth Memorial Hospital Central
Colorado Springs
Poudre Valley Hospital
Fort Collins
Connecticut
Hartford Hospital
Hartford
Florida
Boca Raton Regional Hospital
Boca Raton
University of Florida Health Science Center - Gainesville
Gainesville
Baptist MD Anderson Cancer Center
Jacksonville
Baptist Medical Center South
Jacksonville
University of Florida Health Science Center - Jacksonville
Jacksonville
Miami Cancer Institute
Miami
Moffitt Cancer Center
Tampa
Georgia
Emory Proton Therapy Center
Atlanta
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Iowa
Mercy Hospital
Cedar Rapids
Iowa Methodist Medical Center
Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Illinois
John H Stroger Jr Hospital of Cook County
Chicago
Northwestern University
Chicago
Rush University Medical Center
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
Decatur Memorial Hospital
Decatur
Northwestern Medicine Cancer Center Kishwaukee
Dekalb
Northwestern Medicine Cancer Center Delnor
Geneva
UC Comprehensive Cancer Center at Silver Cross
New Lenox
Advocate Lutheran General Hospital
Park Ridge
OSF Saint Francis Medical Center
Peoria
Memorial Medical Center
Springfield
Northwestern Medicine Cancer Center Warrenville
Warrenville
Indiana
Parkview Hospital Randallia
Fort Wayne
Parkview Regional Medical Center
Fort Wayne
Radiation Oncology Associates PC
Fort Wayne
Community Cancer Center East
Indianapolis
Community Cancer Center North
Indianapolis
Community Cancer Center South
Indianapolis
IU Health Methodist Hospital
Indianapolis
IU Health Ball Memorial Hospital
Muncie
Kansas
University of Kansas Cancer Center
Kansas City
University of Kansas Cancer Center-Overland Park
Overland Park
Kentucky
Norton Hospital Pavilion and Medical Campus
Louisville
Louisiana
Ochsner Medical Center Jefferson
New Orleans
Willis-Knighton Medical and Cancer Center
Shreveport
Massachusetts
Boston Medical Center
Boston
Massachusetts General Hospital Cancer Center
Boston
Tufts Medical Center
Boston
Mass General/North Shore Cancer Center
Danvers
Lowell General Hospital
Lowell
Maryland
Maryland Proton Treatment Center
Baltimore
University of Maryland/Greenebaum Cancer Center
Baltimore
UM Upper Chesapeake Medical Center
Bel Air
Central Maryland Radiation Oncology in Howard County
Columbia
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
McLaren Cancer Institute-Bay City
Bay City
Beaumont Hospital - Dearborn
Dearborn
Henry Ford Hospital
Detroit
McLaren Cancer Institute-Flint
Flint
Mercy Health Saint Mary's
Grand Rapids
Spectrum Health at Butterworth Campus
Grand Rapids
West Michigan Cancer Center
Kalamazoo
McLaren Cancer Institute-Lapeer Region
Lapeer
Saint Mary Mercy Hospital
Livonia
McLaren Cancer Institute-Macomb
Mount Clemens
McLaren Cancer Institute-Central Michigan
Mount Pleasant
McLaren Cancer Institute-Owosso
Owosso
McLaren Cancer Institute-Northern Michigan
Petoskey
Saint Joseph Mercy Oakland
Pontiac
William Beaumont Hospital-Royal Oak
Royal Oak
Lakeland Medical Center Saint Joseph
Saint Joseph
William Beaumont Hospital - Troy
Troy
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Saint Luke's Hospital of Duluth
Duluth
Mayo Clinic in Rochester
Rochester
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud
Regions Hospital
Saint Paul
Missouri
North Kansas City Hospital
Kansas City
University of Kansas Cancer Center - North
Kansas City
Washington University School of Medicine
Saint Louis
Mississippi
University of Mississippi Medical Center
Jackson
Montana
Billings Clinic Cancer Center
Billings
North Carolina
Mission Hospital
Asheville
Novant Health Forsyth Medical Center
Winston-salem
Wake Forest University Health Sciences
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Roger Maris Cancer Center
Fargo
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Rutgers Cancer Institute of New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick
Capital Health Medical Center-Hopewell
Pennington
ProCure Proton Therapy Center-Somerset
Somerset
Virtua Voorhees
Voorhees
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
Renown Regional Medical Center
Reno
Saint Mary's Regional Medical Center
Reno
New York
Montefiore Medical Center - Moses Campus
Bronx
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn
Memorial Sloan Kettering Commack
Commack
Memorial Sloan Kettering Westchester
Harrison
Northwell Health/Center for Advanced Medicine
Lake Success
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Memorial Sloan Kettering Cancer Center
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York
Ohio
Cleveland Clinic Akron General
Akron
UHHS-Chagrin Highlands Medical Center
Beachwood
Geauga Hospital
Chardon
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Riverside Methodist Hospital
Columbus
Mercy Cancer Center-Elyria
Elyria
Cleveland Clinic Cancer Center Independence
Independence
Hillcrest Hospital Cancer Center
Mayfield Heights
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights
University Hospitals Parma Medical Center
Parma
North Coast Cancer Care
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky
Cleveland Clinic Cancer Center Strongsville
Strongsville
University of Toledo
Toledo
University of Cincinnati Cancer Center-West Chester
West Chester
UHHS-Westlake Medical Center
Westlake
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Willamette Valley Cancer Center
Eugene
Legacy Mount Hood Medical Center
Gresham
Legacy Good Samaritan Hospital and Medical Center
Portland
Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem
Northeast Radiation Oncology Center
Dunmore
Ephrata Cancer Center
Ephrata
Adams Cancer Center
Gettysburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg
Sechler Family Cancer Center
Lebanon
Jefferson Torresdale Hospital
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Philadelphia
Reading Hospital
West Reading
WellSpan Health-York Cancer Center
York
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Medical University of South Carolina
Charleston
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Self Regional Healthcare
Greenwood
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
Tennessee Cancer Specialists-Dowell Springs
Knoxville
Texas
Austin Cancer Centers-Central Austin
Austin
Austin Cancer Centers-North
Austin
Dell Seton Medical Center at The University of Texas
Austin
Texas Oncology - Central Austin Cancer Center
Austin
Texas Oncology - South Austin Cancer Center
Austin
Texas Oncology-Austin Midtown
Austin
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Texas Oncology - Denison Cancer Center
Denison
Texas Oncology-Flower Mound
Flower Mound
Texas Oncology - Fort Worth Cancer Center
Fort Worth
University of Texas Medical Branch
Galveston
M D Anderson Cancer Center
Houston
Memorial Hermann Memorial City Medical Center
Houston
UTMB Cancer Center at Victory Lakes
League City
Covenant Medical Center-Lakeside
Lubbock
Texas Oncology - Round Rock Cancer Center
Round Rock
Texas Oncology-Seton Williamson
Round Rock
University of Texas Health Science Center at San Antonio
San Antonio
Texas Oncology Cancer Center Sugar Land
Sugar Land
Tyler Cancer Center
Tyler
Utah
Logan Regional Hospital
Logan
Intermountain Medical Center
Murray
McKay-Dee Hospital Center
Ogden
Utah Valley Regional Medical Center
Provo
Dixie Medical Center Regional Cancer Center
Saint George
Huntsman Cancer Institute/University of Utah
Salt Lake City
Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin
University of Vermont Medical Center
Burlington
Norris Cotton Cancer Center-North
Saint Johnsbury
Washington
SCCA Proton Therapy Center
Seattle
Seattle Cancer Care Alliance at Northwest Hospital
Seattle
University of Washington Medical Center - Montlake
Seattle
Compass Oncology Vancouver
Vancouver
Legacy Salmon Creek Hospital
Vancouver
Wisconsin
Langlade Hospital and Cancer Center
Antigo
Gundersen Lutheran Medical Center
La Crosse
University of Wisconsin Carbone Cancer Center
Madison
Froedtert Menomonee Falls Hospital
Menomonee Falls
Medical College of Wisconsin
Milwaukee
UW Cancer Center at ProHealth Care
Waukesha
Aspirus Regional Cancer Center
Wausau
West Virginia
Wheeling Hospital/Schiffler Cancer Center
Wheeling
Other Locations
Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal
CHUM - Hopital Notre-Dame
Montreal
McGill University Department of Oncology
Montreal
The Research Institute of the McGill University Health Centre (MUHC)
Montreal
Ottawa Hospital and Cancer Center-General Campus
Ottawa
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Quebec City
Saskatoon Cancer Centre
Saskatoon
BCCA-Vancouver Island Cancer Centre
Victoria
Windsor Regional Cancer Centre
Windsor
Time Frame
Start Date: October 27, 2014
Estimated Completion Date: May 2026
Participants
Target number of participants: 624
Treatments
Active Comparator: Arm A1 (control)
Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT QD, 5 days a week for 23 fractions plus a boost of 7 additional fractions.~In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B (photon IMRT)
Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions.~In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Active Comparator: Arm A2 (control)
Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1.~In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Arm C (proton beam radiation therapy)
Patients undergo dose-escalated and -intensified proton beam therapy QD, 5 days a week for a total of 30 fractions.~In all treatment arms, patients receive temozolomide PO QD on days 1-49 of radiation therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Authors
Rahul R. Parikh, John E. Mignano, Timothy J. Kruser, Vinai Gondi, Mitchell Machtay, Daniel E. Spratt, Robert J. Behrens, Xiao-Tang Kong, Ruben C. Fragoso, Bryan A. Faller, Matthew S. Katz, Samuel T. Chao, Robert D. Timmerman, Preston D. Steen, Arnab Chakravarti, Joshua S. Silverman, Shirnett K. Williamson, Andrew Y. Kee, Ian R. Crocker, Marcio A. Fagundes, Ronny L. Rotondo, Sajeel A. Chowdhary, Kevin P. Redmond, Steven P. Howard, Richard L. Crownover, Howard A. Zaren, Donald J. Jurgens, Anthony D. Elias, Minesh Mehta, Michael S. Rutenberg, Thomas E. Lad, Robert B. Ash, Christopher U. Jones, Robert A. Lustig, Jiayi Huang, James E. Ruffer, Michael M. Dominello, Grant K. Hunter, Aidnag Z. Diaz, Lia M. Halasz, Brian D. Vaillant, Andrew J. Bishop, Brian K. Chang, Stephen L. Shiao, Christian C. Hyde, Janet G. Turner, Joseph A. Bovi, Eleanor M. Walker, Joshua M. Mammen, Carl J. Nelson, Todd A. Swanson, Madhur K. Garg, Jack J. Hong, Mitchel L. Fromm, Michael D. Zurenko, Steven R. Bonin, Wenyin Shi, Helen A. Shih, Samir Narayan, David L. Grisell, Hani L. Ashamalla, Terrence P. Cescon, Dennis C. Shrieve, John P. Kuebler, Samuel L. Cooper, Steven J. Chmura, Chenyang Wang, Collin D. Driscoll, Lemuel S. Ariaratnam, Richard L. Jennelle, Sanjay Maraboyina, David C. Weksberg, Atif J. Khan, Jordan Kharofa, Hui-Kuo G. Shu, Samantha A. Seaward, Nimisha Deb, Mariza Daras, Alan C. Hartford, Thomas J. Kaley, Prakash Chinnaiyan, Serah Choi, David G. Brachman, Jondavid Pollock, Paul J. Anderson, Rupesh R. Kotecha, Sujay A. Vora, James L. Wade, Benjamin T. Marchello, Terence S. Herman, Michelle M. Kim, Augusto C. Ochoa, Anita Mahajan, Mark V. Mishra, Judith O. Hopkins, Darryl R. Barton, Aaron C. Spalding, John B. Fiveash, Vivek S. Kavadi, Daniel W. Weed, Susan Y. Kim, Marjaneh Moini, Joseph I. Kang, Gordon A. Watson, Yallapragada S. Rao, Kevin P. McMullen, Sameer Rafla-Demetrious, J. S. Thompson, Tony J. Wang, Timothy J. Harris, Simon S. Lo, Jean-Michel Caudrelier, Baldassarre (. Stea, Amit B. Shah, Krishna Reddy, Abraham S. Alexander, Michael D. Chan, Christopher H. Chay, Hsiang-Hsuan M. Yu, Valerie Panet-Raymond, Khalid J. Hirmiz, Jean-Paul Bahary, Kathleen J. Yost, John A. Ellerton, J. B. Wilkinson
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI), Radiation Therapy Oncology Group

This content was sourced from clinicaltrials.gov

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