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Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients with Newly Diagnosed Glioblastoma

Trial Status: Active

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.

Inclusion Criteria

  • PRIOR TO STEP 1 REGISTRATION
  • A diagnostic contrast-enhanced MRI (no other scan type allowed) of the brain must be performed postoperatively; the residual enhancing tumor and/or resection cavity must have a maximal diameter of 5 cm or less; 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 * The postoperative brain MRI should be obtained within 72 hours of resection; if it is not obtained within 72 hours post-resection, then an MRI obtained 2 weeks or longer after surgery is required and can be utilized to ensure maximal diameter of residual tumor and/or resection cavity is 5 cm or less * For cases where a gross total resection of enhancing tumor is performed, but postoperative surgical cavity is NOT identifiable, the patient will be excluded from the trial
  • Tumor tissue must be available for submission for central pathology review * Timing requirements: ** If MGMT has been assessed locally by LabCorps or MD Anderson Cancer Center Molecular Diagnostics Lab (MDACC-MDL): *** Tissue for central pathology review and central MGMT assessment and the official LabCorps or MDACC-MDL MGMT result must be received by the NRG Oncology Biospecimen Bank on or before postoperative calendar day 40 *** The site’s local MGMT report from LabCorp or MDACC-MDL will then be used to stratify the patient; a post-stratification MGMT central review will be performed, but step 2 registration and protocol treatment can proceed without central review of MGMT *** Patients whose tissue for central pathology review and official LabCorps or MDACC-MDL MGMT result cannot be received by NRG Oncology Biospecimen Bank on or before 40 calendar days after surgery may NOT enroll on this trial, as central pathology review and stratification will not be complete in time for the patient to start treatment within 49 calendar days following surgery ** If MGMT has not been assessed locally by LabCorps or MDACC-MDL: *** Tissue for central pathology review and central MGMT assessment must be received by the NRG Oncology Biospecimen Bank on or before postoperative calendar day 30 *** Central MGMT analysis will be performed at MDACC-MDL and used for patient stratification; results will be conveyed to NRG Oncology within 10 business days of receipt of the tissue *** Patients who have not had local MGMT assessment by LabCorps or MDACC-MDL and whose tissue for central pathology review cannot be received by NRG Oncology Biospecimen Bank on or before 30 calendar days after surgery may NOT enroll on this trial, as central pathology review and stratification will not be complete in time for the patient to start treatment within 49 calendar days following surgery * Tissue Requirements: ** Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged to maximize the chances of eligibility; in total, at least 1 cubic centimeter of tissue composed primarily of tumor must be present ** Submission of an accompanying hematoxylin and eosin H&E slide(s) is MANDATORY ** Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy and cavitronic ultrasonic surgical (CUSA) techniques are not allowed
  • The 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 central analysis of MGMT status
  • 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
  • Complete blood count (CBC)/differential obtained within 28 days prior to step 2 registration
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 28 days prior to step 2 registration)
  • Platelets >= 100,000 cells/mm^3 (obtained within 28 days prior to step 2 registration)
  • Hemoglobin >= 10.0 g/dl (obtained within 28 days prior to step 2 registration) (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) (within 28 days prior to step 2 registration)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (within 28 days prior to step 2 registration)
  • Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration
  • As of Amendment 2, if the registering site is a photon center (registering patients to group I), the patient must agree to participate in the advanced imaging sub-study

Exclusion Criteria

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Recurrent or multifocal malignant gliomas
  • Any site of distant disease (for example, drop metastases from the GBM tumor site)
  • Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide)
  • Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
  • Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
  • Severe, active co-morbidity, defined as follows: * Unstable angina at step 2 registration * Transmural myocardial infarction within the last 6 months prior to step 2 registration * Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to step 2 registration (Note: EKG to be performed only if clinical suspicion of cardiac issue) * New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration * Serious and inadequately controlled arrhythmia at step 2 registration * Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for surgical resection * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is because the treatments involved in this protocol may be significantly immunosuppressive with potentially fatal outcomes in patients already immunosuppressed * Any other severe immunocompromised condition * Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity * End-stage renal disease (ie, on dialysis or dialysis has been recommended) * Any other major medical illnesses or psychiatric treatments that in the investigator’s opinion will prevent administration or completion of protocol therapy
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • Patents treated on any other therapeutic clinical protocols within 30 days prior to step 2 registration
  • Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker, or severe claustrophobia)
  • Postoperative tumor plus surgical bed size exceeds 5 cm in maximum diameter

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 205-934-0220

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Saint Joseph's Hospital and Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-602-4111
Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Tucson
Arizona Oncology Associates-West Orange Grove
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 520-544-2919
Banner University Medical Center - Tucson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 501-686-8274

California

Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Bakersfield
AIS Cancer Center at San Joaquin Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 661-323-4673
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Castro Valley
Eden Hospital Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Greenbrae
Marin General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-925-7325
Loma Linda
Loma Linda University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 909-558-4050
Los Angeles
Cedars Sinai Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 310-423-8965
Los Angeles County-USC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
Marysville
Fremont - Rideout Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 530-749-4400
Modesto
Memorial Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Oakland
Kaiser Permanente Oakland-Broadway
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Saint Joseph Hospital - Orange
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 714-734-6220
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-827-8839
Palo Alto
Palo Alto Medical Foundation Health Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Pomona
Pomona Valley Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 909-865-9555
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Rohnert Park
Rohnert Park Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
The Permanente Medical Group-Roseville Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
South Sacramento Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sutter Medical Center Sacramento
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
University of California Davis Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
California Pacific Medical Center-Pacific Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Walnut Creek
John Muir Medical Center-Walnut Creek
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 925-941-4246

Colorado

Colorado Springs
UCHealth Memorial Hospital Central
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-365-2406
Fort Collins
Poudre Valley Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 970-297-6150

Connecticut

Hartford
Hartford Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 860-545-5363

Florida

Boca Raton
Boca Raton Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 561-955-4800
Gainesville
University of Florida Health Science Center - Gainesville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 352-273-8010
Jacksonville
Baptist MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 904-202-7468
Baptist Medical Center South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 904-202-7027
University of Florida Health Science Center - Jacksonville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-254-7581
Miami
Miami Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 786-596-2000
Tampa
Moffitt Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-679-0775

Georgia

Atlanta
Emory Proton Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-251-2854
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-819-5704

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-864-5204
Northwestern University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-695-1301
Rush University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-942-5498
University of Chicago Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Decatur
Decatur Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 773-702-8222
Park Ridge
Advocate Lutheran General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 847-384-3621
Peoria
OSF Saint Francis Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360

Indiana

Fort Wayne
Parkview Hospital Randallia
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 260-373-8888
Parkview Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-784-4673
Radiation Oncology Associates PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-437-2408
Indianapolis
Community Cancer Center East
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-497-2823
Community Cancer Center North
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-497-2823
Community Cancer Center South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-497-2823
IU Health Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 317-278-5632
Muncie
IU Health Ball Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 765-751-5850

Iowa

Cedar Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 319-365-4673
Des Moines
Iowa Methodist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-6727

Kansas

Kansas City
University of Kansas Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-588-3671
Overland Park
University of Kansas Cancer Center-Overland Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-588-3671

Kentucky

Louisville
Norton Hospital Pavilion and Medical Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 502-629-2500

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 504-703-8712
Shreveport
Willis-Knighton Medical and Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 504-210-3539

Maryland

Baltimore
Maryland Proton Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-369-5226
University of Maryland / Greenebaum Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-888-8823
Bel Air
UM Upper Chesapeake Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-643-3010
Columbia
Central Maryland Radiation Oncology in Howard County
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 443-546-1300
Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-553-8100

Massachusetts

Boston
Boston Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 617-638-8265
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-726-5130
Tufts Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 617-636-5000
Danvers
Mass General / North Shore Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 978-882-6032
Lowell
Lowell General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 978-788-7084

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-865-1125
Dearborn
Beaumont Hospital - Dearborn
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Detroit
Henry Ford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Flint
McLaren Cancer Institute-Flint
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Grand Rapids
Mercy Health Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Livonia
Saint Mary Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Mount Clemens
McLaren Cancer Institute-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Owosso
McLaren Cancer Institute-Owosso
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Pontiac
Saint Joseph Mercy Oakland
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Royal Oak
William Beaumont Hospital-Royal Oak
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Troy
William Beaumont Hospital - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-333-5000
Duluth
Saint Luke's Hospital of Duluth
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-249-7825
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-229-4907
Saint Paul
Regions Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Kansas City
North Kansas City Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 816-691-1599
University of Kansas Cancer Center - North
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-588-3671
Saint Louis
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606

Montana

Billings
Billings Clinic Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663

Nevada

Las Vegas
Comprehensive Cancer Centers of Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Renown Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-639-6918

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 732-235-7356
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 732-235-8675
Pennington
Capital Health Medical Center-Hopewell
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 609-394-4130
Somerset
ProCure Proton Therapy Center-Somerset
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-967-7628
Voorhees
Virtua Voorhees
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 856-247-7395

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-780-3677
Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Lake Success
Northwell Health / Center for Advanced Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 516-734-8896
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-263-4434
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-305-6361
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592

North Carolina

Asheville
Mission Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 828-775-7211
Winston-Salem
Novant Health Forsyth Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-718-8335
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Roger Maris Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Akron
Cleveland Clinic Akron General
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
Beachwood
UHHS-Chagrin Highlands Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Chardon
Geauga Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-558-4553
Cleveland
Case Western Reserve University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Cleveland Clinic Cancer Center / Fairview Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-293-5066
Riverside Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-4475
Elyria
Mercy Cancer Center-Elyria
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Independence
Cleveland Clinic Cancer Center Independence
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Parma
University Hospitals Parma Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Sandusky
North Coast Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100
Toledo
University of Toledo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-383-6583
West Chester
University Pointe
Status: ACTIVE
Contact: Site Public Contact
Westlake
UHHS-Westlake Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 866-223-8100

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Eugene
Willamette Valley Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 541-681-4930
Gresham
Legacy Mount Hood Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-220-4937

Pennsylvania

Bethlehem
Saint Luke's University Hospital-Bethlehem Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 484-503-4151
Dunmore
Northeast Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-808-6762
Ephrata
Ephrata Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-721-4840
Gettysburg
Adams Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-441-7957
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-724-6765
Lebanon
Sechler Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-741-8303
Philadelphia
Aria Health-Torresdale Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-612-5296
Thomas Jefferson University Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-955-6084
University of Pennsylvania / Abramson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-474-9892
West Reading
Reading Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 610-988-9323
York
WellSpan Health-York Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-441-7957

South Carolina

Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 843-792-9321
Greenville
Prisma Health Cancer Institute - Eastside
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Greenwood
Self Regional Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-725-4771
Greer
Prisma Health Cancer Institute - Greer
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Knoxville
Tennessee Cancer Specialists-Dowell Springs
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 865-244-3209

Texas

Austin
Austin Cancer Centers-Central Austin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Austin Cancer Centers-North
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Dell Seton Medical Center at The University of Texas
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 512-324-7991
Texas Oncology - Central Austin Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 512-427-9400
Texas Oncology - South Austin Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 512-447-2202
Texas Oncology-Austin Midtown
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 512-421-4163
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 214-648-7097
Flower Mound
Texas Oncology-Flower Mound
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 972-537-4100
Fort Worth
Texas Oncology - Fort Worth Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 817-820-4700
Galveston
University of Texas Medical Branch
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 409-772-1950
Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
Memorial Hermann Memorial City Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-339-5294
League City
UTMB Cancer Center at Victory Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-917-8906
Lubbock
Covenant Medical Center-Lakeside
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 806-725-8000
Round Rock
Texas Oncology - Round Rock Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 512-341-8724
Texas Oncology-Seton Williamson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 512-687-2300
San Antonio
University of Texas Health Science Center at San Antonio
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 210-450-3800
Sherman
Texas Cancer Center-Sherman
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 903-868-4700
Sugar Land
Texas Oncology Cancer Center Sugar Land
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 281-277-5200
Tyler
Tyler Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 903-579-9800

Utah

Logan
Logan Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-716-6400
Murray
Intermountain Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-507-3950
Ogden
McKay-Dee Hospital Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-387-7426
Provo
Utah Valley Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-357-7965
Saint George
Dixie Medical Center Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-688-4167
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu
Saint Johnsbury
Norris Cotton Cancer Center-North
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 802-473-4100

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 804-628-1914

Washington

Seattle
SCCA Proton Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-306-2800
Seattle Cancer Care Alliance at Northwest Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-606-5800
University of Washington Medical Center - Montlake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-8824
Vancouver
Compass Oncology Vancouver
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-449-6521
Legacy Salmon Creek Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-413-2150

West Virginia

Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 304-243-6442

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 715-623-9869
La Crosse
Gundersen Lutheran Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 608-775-2385
Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-622-8922
Menomonee Falls
Froedtert Menomonee Falls Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 262-257-5100
Milwaukee
Medical College of Wisconsin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-805-3666
Waukesha
UW Cancer Center at ProHealth Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 262-928-5539
Wausau
Aspirus Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-405-6866

British Columbia

Victoria
BCCA-Vancouver Island Cancer Centre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 604-877-6010

Ontario

Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 613-761-4395
Windsor
Windsor Regional Cancer Centre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 519-253-5253

Quebec

Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 514-890-8000ext12725
CHUM - Hopital Notre-Dame
Status: ACTIVE
Contact: Jean-Paul Bahary
Phone: 514-890-8000ext14788
McGill University Department of Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Valerie Panet-Raymond
Phone: 514-934-4400
The Research Institute of the McGill University Health Centre (MUHC)
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 514-934-1934ext48354
Quebec City
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Saskatchewan

Saskatoon
Saskatoon Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 306-655-2914

PRIMARY OBJECTIVE:

I. To determine if dose-escalated and -intensified photon IMRT or proton beam therapy (using a dose-per-fraction escalation with simultaneous integrated boost) with concomitant and adjuvant temozolomide improves overall survival, as compared to standard-dose photon irradiation with concomitant and adjuvant temozolomide.

SECONDARY OBJECTIVES:

I. To indirectly compare dose-escalated and -intensified photon IMRT to dose-escalated and -intensified proton beam therapy in terms of overall survival.

II. To indirectly compare and record toxicities of dose-escalated and -intensified photon IMRT versus dose-escalated and -intensified proton beam therapy and directly compare the toxicities of these approaches versus standard-dose photon irradiation on the backbone of concomitant and adjuvant temozolomide.

III. To determine if dose-escalated and -intensified IMRT or proton beam therapy (using a dose-per-fraction escalation with simultaneous integrated boost) with concomitant and adjuvant temozolomide improves perceived cognitive symptom severity, as compared to standard-dose photon irradiation with concomitant and adjuvant temozolomide.

IV. To determine if dose-escalated and -intensified photon IMRT or proton beam therapy (using a dose-per-fraction escalation with simultaneous integrated boost) with concomitant and adjuvant temozolomide improves neurocognitive function, as compared to standard-dose photon irradiation with concomitant and adjuvant temozolomide.

V. To indirectly determine if dose-escalated and -intensified proton beam therapy with concomitant and adjuvant temozolomide improves perceived cognitive symptom severity, as compared to dose-escalated and -intensified photon IMRT, and to directly compare symptom burden with these approaches versus standard-dose photon irradiation on the backbone of concomitant and adjuvant temozolomide.

VI. To indirectly determine if dose-escalated and -intensified proton beam therapy with concomitant and adjuvant temozolomide improves neurocognitive function, as compared to dose-escalated and -intensified photon IMRT, and to directly compare neurocognitive function with these approaches versus standard-dose photon irradiation on the backbone of concomitant and adjuvant temozolomide.

EXPLORATORY OBJECTIVES:

I. Tissue banking for future translational science projects that will be determined based on the state of the science at the time the primary endpoint is reported and will be submitted to National Cancer Institute (NCI) for review and approval.

II. To prospectively compare CD4 lymphopenia between dose-escalated and intensified proton beam therapy, dose-escalated and -intensified photon IMRT, and standard-dose photon irradiation and determine whether CD4 lymphopenia impacts overall survival.

III. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery.

IIIa. To establish feasibility and clinical relevancy of quality assurance guidelines.

IIIb. To evaluate efficacy of quality assurance tools.

IV. To explore the most appropriate and clinically relevant advanced and standard magnetic resonance imaging (MRI) imaging parameters.

IVa. To evaluate the feasibility of differentiating pseudo-progression and true progression in a multi institutional setting using magnetic resonance (MR) diffusion and perfusion imaging.

IVb. To evaluate for early, imaging biomarkers of response and overall survival.

OUTLINE: Patients are assigned to 1 of 2 groups depending on enrolling institution. Within each group, patients will be randomized 1:2 in favor of the experimental arms.

GROUP I (PHOTON IMRT CENTERS): Patients are randomized to 1 of 2 treatment arms.

ARM A1: Patients undergo standard-dose photon irradiation using 3-dimensional conformal radiation therapy (3D-CRT) or IMRT once daily (QD), 5 days a week for 23 fractions plus a boost of 7 additional fractions.

ARM B: Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a total of 30 fractions.

GROUP II (PROTON CENTERS): Patients are randomized to 1 of 2 treatment arms.

ARM A2: Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1.

ARM C: Patients undergo dose-escalated and -intensified proton beam radiation therapy QD, 5 days a week for a total of 30 fractions.

In all treatment arms, patients receive temozolomide orally (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 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Minesh P. Mehta

  • Primary ID NRG-BN001
  • Secondary IDs NCI-2014-01072
  • Clinicaltrials.gov ID NCT02179086