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Dosiseskalierte Photonen-IMRT oder Protonenstrahl-Strahlentherapie im Vergleich zu Standarddosis-Strahlentherapie und Temozolomid bei der Behandlung von Patienten mit neu diagnostiziertem Glioblastom

9. September 2026 aktualisiert von: NRG Oncology

Randomisierte Phase-II-Studie mit hypofraktionierter, dosiseskalierter Photonen-IMRT oder Protonenstrahltherapie im Vergleich zu konventioneller Photonenbestrahlung mit gleichzeitigem und adjuvantem Temozolomid bei Patienten mit neu diagnostiziertem Glioblastom

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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 1 = PHOTON IMRT CENTERS. GROUP 2 = PROTON CENTERS.

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

624

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • British Columbia
      • Victoria, British Columbia, Kanada, V8R 6V5
        • BCCA-Vancouver Island Cancer Centre
    • Ontario
      • Ottawa, Ontario, Kanada, K1H 8L6
        • Ottawa Hospital and Cancer Center-General Campus
      • Windsor, Ontario, Kanada, N8W 2X3
        • Windsor Regional Cancer Centre
    • Quebec
      • Montreal, Quebec, Kanada, H3H 2R9
        • The Research Institute of the McGill University Health Centre (MUHC)
      • Montreal, Quebec, Kanada, H2X 3E4
        • CHUM - Centre Hospitalier de l'Universite de Montreal
      • Québec, Quebec, Kanada, G1R 2J6
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7N 4H4
        • Saskatoon Cancer Centre
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • University of Alabama at Birmingham Cancer Center
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85054
        • Mayo Clinic Hospital in Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85013
        • Saint Joseph's Hospital and Medical Center
      • Scottsdale, Arizona, Vereinigte Staaten, 85259
        • Mayo Clinic in Arizona
      • Tucson, Arizona, Vereinigte Staaten, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, Vereinigte Staaten, 85704
        • Arizona Oncology Associates-West Orange Grove
    • Arkansas
      • Little Rock, Arkansas, Vereinigte Staaten, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Auburn, California, Vereinigte Staaten, 95603
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
      • Bakersfield, California, Vereinigte Staaten, 93301
        • AIS Cancer Center at San Joaquin Community Hospital
      • Berkeley, California, Vereinigte Staaten, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Cameron Park, California, Vereinigte Staaten, 95682
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
      • Castro Valley, California, Vereinigte Staaten, 94546
        • Eden Hospital Medical Center
      • Fresno, California, Vereinigte Staaten, 93720
        • Fresno Cancer Center
      • Greenbrae, California, Vereinigte Staaten, 94904
        • Marin General Hospital
      • Loma Linda, California, Vereinigte Staaten, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, Vereinigte Staaten, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, Vereinigte Staaten, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, Vereinigte Staaten, 90033
        • Los Angeles General Medical Center
      • Marysville, California, Vereinigte Staaten, 95901
        • Fremont - Rideout Cancer Center
      • Modesto, California, Vereinigte Staaten, 95355
        • Memorial Medical Center
      • Oakland, California, Vereinigte Staaten, 94611
        • Kaiser Permanente Oakland-Broadway
      • Orange, California, Vereinigte Staaten, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Orange, California, Vereinigte Staaten, 92868
        • Saint Joseph Hospital - Orange
      • Palo Alto, California, Vereinigte Staaten, 94301
        • Palo Alto Medical Foundation Health Care
      • Pomona, California, Vereinigte Staaten, 91767
        • Pomona Valley Hospital Medical Center
      • Rancho Cordova, California, Vereinigte Staaten, 95670
        • Kaiser Permanente-Rancho Cordova Cancer Center
      • Rohnert Park, California, Vereinigte Staaten, 94928
        • Rohnert Park Cancer Center
      • Roseville, California, Vereinigte Staaten, 95678
        • The Permanente Medical Group-Roseville Radiation Oncology
      • Roseville, California, Vereinigte Staaten, 95661
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
      • Sacramento, California, Vereinigte Staaten, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Vereinigte Staaten, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, Vereinigte Staaten, 95823
        • South Sacramento Cancer Center
      • San Francisco, California, Vereinigte Staaten, 94115
        • California Pacific Medical Center-Pacific Campus
      • Santa Cruz, California, Vereinigte Staaten, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • South San Francisco, California, Vereinigte Staaten, 94080
        • Kaiser Permanente Cancer Treatment Center
      • Sunnyvale, California, Vereinigte Staaten, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Walnut Creek, California, Vereinigte Staaten, 94598
        • John Muir Medical Center-Walnut Creek
    • Colorado
      • Colorado Springs, Colorado, Vereinigte Staaten, 80909
        • UCHealth Memorial Hospital Central
      • Fort Collins, Colorado, Vereinigte Staaten, 80524
        • Poudre Valley Hospital
    • Connecticut
      • Hartford, Connecticut, Vereinigte Staaten, 06102
        • Hartford Hospital
    • Florida
      • Boca Raton, Florida, Vereinigte Staaten, 33486
        • Boca Raton Regional Hospital
      • Gainesville, Florida, Vereinigte Staaten, 32610
        • UF Health Cancer Institute - Gainesville
      • Jacksonville, Florida, Vereinigte Staaten, 32207
        • Baptist MD Anderson Cancer Center
      • Jacksonville, Florida, Vereinigte Staaten, 32209
        • University of Florida Health Science Center - Jacksonville
      • Jacksonville, Florida, Vereinigte Staaten, 32258
        • Baptist Medical Center South
      • Miami, Florida, Vereinigte Staaten, 33176
        • Miami Cancer Institute
      • Tampa, Florida, Vereinigte Staaten, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Vereinigte Staaten, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, Vereinigte Staaten, 30308
        • Emory Proton Therapy Center
      • Savannah, Georgia, Vereinigte Staaten, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Idaho
      • Boise, Idaho, Vereinigte Staaten, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Northwestern University
      • Chicago, Illinois, Vereinigte Staaten, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • Rush MD Anderson Cancer Center
      • DeKalb, Illinois, Vereinigte Staaten, 60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Decatur, Illinois, Vereinigte Staaten, 62526
        • Decatur Memorial Hospital
      • Geneva, Illinois, Vereinigte Staaten, 60134
        • Northwestern Medicine Cancer Center Delnor
      • New Lenox, Illinois, Vereinigte Staaten, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • Park Ridge, Illinois, Vereinigte Staaten, 60068
        • Advocate Lutheran General Hospital
      • Peoria, Illinois, Vereinigte Staaten, 61637
        • OSF Saint Francis Medical Center
      • Springfield, Illinois, Vereinigte Staaten, 62781
        • Springfield Memorial Hospital
      • Warrenville, Illinois, Vereinigte Staaten, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Fort Wayne, Indiana, Vereinigte Staaten, 46805
        • Parkview Hospital Randallia
      • Fort Wayne, Indiana, Vereinigte Staaten, 46845
        • Parkview Regional Medical Center
      • Fort Wayne, Indiana, Vereinigte Staaten, 46804
        • Radiation Oncology Associates PC
      • Indianapolis, Indiana, Vereinigte Staaten, 46219
        • Community Cancer Center East
      • Indianapolis, Indiana, Vereinigte Staaten, 46227
        • Community Cancer Center South
      • Indianapolis, Indiana, Vereinigte Staaten, 46256
        • Community Cancer Center North
      • Indianapolis, Indiana, Vereinigte Staaten, 46202
        • IU Health Methodist Hospital
      • Muncie, Indiana, Vereinigte Staaten, 47303
        • IU Health Ball Memorial Hospital
    • Iowa
      • Cedar Rapids, Iowa, Vereinigte Staaten, 52403
        • Mercy Hospital
      • Des Moines, Iowa, Vereinigte Staaten, 50309
        • Iowa Methodist Medical Center
    • Kansas
      • Kansas City, Kansas, Vereinigte Staaten, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, Vereinigte Staaten, 66210
        • University of Kansas Cancer Center-Overland Park
    • Kentucky
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • Norton Hospital Pavilion and Medical Campus
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70121
        • Ochsner Medical Center Jefferson
      • Shreveport, Louisiana, Vereinigte Staaten, 71103
        • Willis-Knighton Medical and Cancer Center
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, Vereinigte Staaten, 21201
        • Maryland Proton Treatment Center
      • Bel Air, Maryland, Vereinigte Staaten, 21014
        • UM Upper Chesapeake Medical Center
      • Columbia, Maryland, Vereinigte Staaten, 21044
        • Central Maryland Radiation Oncology in Howard County
      • Glen Burnie, Maryland, Vereinigte Staaten, 21061
        • UM Baltimore Washington Medical Center/Tate Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, Vereinigte Staaten, 02118
        • Boston Medical Center
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • Massachusetts General Hospital Cancer Center
      • Danvers, Massachusetts, Vereinigte Staaten, 01923
        • Mass General/North Shore Cancer Center
      • Lowell, Massachusetts, Vereinigte Staaten, 01854
        • Lowell General Hospital
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, Vereinigte Staaten, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Bay City, Michigan, Vereinigte Staaten, 48706
        • McLaren Cancer Institute-Bay City
      • Dearborn, Michigan, Vereinigte Staaten, 48124
        • Corewell Health Dearborn Hospital
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Henry Ford Hospital
      • Flint, Michigan, Vereinigte Staaten, 48532
        • McLaren Cancer Institute-Flint
      • Grand Rapids, Michigan, Vereinigte Staaten, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, Vereinigte Staaten, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, Vereinigte Staaten, 49007
        • West Michigan Cancer Center
      • Lapeer, Michigan, Vereinigte Staaten, 48446
        • McLaren Cancer Institute-Lapeer Region
      • Livonia, Michigan, Vereinigte Staaten, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Mount Clemens, Michigan, Vereinigte Staaten, 48043
        • McLaren Cancer Institute-Macomb
      • Mount Pleasant, Michigan, Vereinigte Staaten, 48858
        • McLaren Cancer Institute-Central Michigan
      • Owosso, Michigan, Vereinigte Staaten, 48867
        • McLaren Cancer Institute-Owosso
      • Petoskey, Michigan, Vereinigte Staaten, 49770
        • McLaren Cancer Institute-Northern Michigan
      • Pontiac, Michigan, Vereinigte Staaten, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Royal Oak, Michigan, Vereinigte Staaten, 48073
        • Corewell Health William Beaumont University Hospital
      • Saint Joseph, Michigan, Vereinigte Staaten, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Troy, Michigan, Vereinigte Staaten, 48085
        • Corewell Health Beaumont Troy Hospital
    • Minnesota
      • Bemidji, Minnesota, Vereinigte Staaten, 56601
        • Sanford Joe Lueken Cancer Center
      • Duluth, Minnesota, Vereinigte Staaten, 55805
        • Saint Luke's Hospital of Duluth
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, Vereinigte Staaten, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Paul, Minnesota, Vereinigte Staaten, 55101
        • Regions Hospital
    • Mississippi
      • Jackson, Mississippi, Vereinigte Staaten, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, Vereinigte Staaten, 64116
        • North Kansas City Hospital
      • St Louis, Missouri, Vereinigte Staaten, 63110
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, Vereinigte Staaten, 59101
        • Billings Clinic Cancer Center
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89148
        • Comprehensive Cancer Centers of Nevada
      • Reno, Nevada, Vereinigte Staaten, 89502
        • Renown Regional Medical Center
      • Reno, Nevada, Vereinigte Staaten, 89503
        • Saint Mary's Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, Vereinigte Staaten, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Basking Ridge, New Jersey, Vereinigte Staaten, 07920
        • Memorial Sloan Kettering Basking Ridge
      • New Brunswick, New Jersey, Vereinigte Staaten, 08903
        • Rutgers Cancer Institute of New Jersey
      • New Brunswick, New Jersey, Vereinigte Staaten, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
      • Pennington, New Jersey, Vereinigte Staaten, 08534
        • Capital Health Medical Center-Hopewell
      • Somerset, New Jersey, Vereinigte Staaten, 08873
        • ProCure Proton Therapy Center-Somerset
      • Voorhees Township, New Jersey, Vereinigte Staaten, 08043
        • Virtua Voorhees
    • New York
      • Brooklyn, New York, Vereinigte Staaten, 11215
        • New York-Presbyterian/Brooklyn Methodist Hospital
      • Commack, New York, Vereinigte Staaten, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, Vereinigte Staaten, 10604
        • Memorial Sloan Kettering Westchester
      • Lake Success, New York, Vereinigte Staaten, 11042
        • Northwell Health/Center for Advanced Medicine
      • New York, New York, Vereinigte Staaten, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Vereinigte Staaten, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, Vereinigte Staaten, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • The Bronx, New York, Vereinigte Staaten, 10467
        • Montefiore Medical Center - Moses Campus
    • North Carolina
      • Asheville, North Carolina, Vereinigte Staaten, 28801
        • Mission Hospital
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27157
        • Wake Forest University Health Sciences
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27103
        • Novant Health Forsyth Medical Center
    • North Dakota
      • Bismarck, North Dakota, Vereinigte Staaten, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Vereinigte Staaten, 58122
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Akron, Ohio, Vereinigte Staaten, 44307
        • Cleveland Clinic Akron General
      • Beachwood, Ohio, Vereinigte Staaten, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Chardon, Ohio, Vereinigte Staaten, 44024
        • Geauga Hospital
      • Cincinnati, Ohio, Vereinigte Staaten, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cleveland, Ohio, Vereinigte Staaten, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Vereinigte Staaten, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Vereinigte Staaten, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Vereinigte Staaten, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Ohio State University Comprehensive Cancer Center
      • Elyria, Ohio, Vereinigte Staaten, 44035
        • Mercy Cancer Center-Elyria
      • Independence, Ohio, Vereinigte Staaten, 44131
        • Cleveland Clinic Cancer Center Independence
      • Mayfield Heights, Ohio, Vereinigte Staaten, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, Vereinigte Staaten, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Middleburg Heights, Ohio, Vereinigte Staaten, 44130
        • UH Seidman Cancer Center at Southwest General Hospital
      • Parma, Ohio, Vereinigte Staaten, 44129
        • University Hospitals Parma Medical Center
      • Sandusky, Ohio, Vereinigte Staaten, 44870
        • North Coast Cancer Care
      • Sandusky, Ohio, Vereinigte Staaten, 44870
        • UH Seidman Cancer Center at Firelands Regional Medical Center
      • Strongsville, Ohio, Vereinigte Staaten, 44136
        • Cleveland Clinic Cancer Center Strongsville
      • Toledo, Ohio, Vereinigte Staaten, 43614
        • University of Toledo
      • West Chester, Ohio, Vereinigte Staaten, 45069
        • University of Cincinnati Cancer Center-West Chester
      • Westlake, Ohio, Vereinigte Staaten, 44145
        • UHHS-Westlake Medical Center
      • Wooster, Ohio, Vereinigte Staaten, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Eugene, Oregon, Vereinigte Staaten, 97401
        • Willamette Valley Cancer Center
      • Gresham, Oregon, Vereinigte Staaten, 97030
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, Vereinigte Staaten, 97210
        • Legacy Good Samaritan Hospital and Medical Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, Vereinigte Staaten, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Dunmore, Pennsylvania, Vereinigte Staaten, 18512
        • Northeast Radiation Oncology Center
      • Ephrata, Pennsylvania, Vereinigte Staaten, 17522
        • Ephrata Cancer Center
      • Gettysburg, Pennsylvania, Vereinigte Staaten, 17325
        • Adams Cancer Center
      • Harrisburg, Pennsylvania, Vereinigte Staaten, 17109
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
      • Lebanon, Pennsylvania, Vereinigte Staaten, 17042
        • Sechler Family Cancer Center
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19114
        • Jefferson Torresdale Hospital
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • West Reading, Pennsylvania, Vereinigte Staaten, 19611
        • Reading Hospital
      • York, Pennsylvania, Vereinigte Staaten, 17403
        • WellSpan Health-York Cancer Center
    • South Carolina
      • Boiling Springs, South Carolina, Vereinigte Staaten, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, Vereinigte Staaten, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, Vereinigte Staaten, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Vereinigte Staaten, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenwood, South Carolina, Vereinigte Staaten, 29646
        • Self Regional Healthcare
      • Greer, South Carolina, Vereinigte Staaten, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, Vereinigte Staaten, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Sioux Falls, South Dakota, Vereinigte Staaten, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
    • Tennessee
      • Knoxville, Tennessee, Vereinigte Staaten, 37909
        • Tennessee Cancer Specialists-Dowell Springs
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78701
        • Dell Seton Medical Center at The University of Texas
      • Austin, Texas, Vereinigte Staaten, 78702
        • Austin Cancer Centers-Central Austin
      • Austin, Texas, Vereinigte Staaten, 78705
        • Texas Oncology-Austin Midtown
      • Austin, Texas, Vereinigte Staaten, 78731
        • Texas Oncology - Central Austin Cancer Center
      • Austin, Texas, Vereinigte Staaten, 78745
        • Texas Oncology - South Austin Cancer Center
      • Austin, Texas, Vereinigte Staaten, 78758
        • Austin Cancer Centers-North
      • Dallas, Texas, Vereinigte Staaten, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Denison, Texas, Vereinigte Staaten, 75020
        • Texas Oncology - Denison Cancer Center
      • Flower Mound, Texas, Vereinigte Staaten, 75028
        • Texas Oncology-Flower Mound
      • Fort Worth, Texas, Vereinigte Staaten, 76104
        • Texas Oncology - Fort Worth Cancer Center
      • Galveston, Texas, Vereinigte Staaten, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, Vereinigte Staaten, 77030
        • M D Anderson Cancer Center
      • Houston, Texas, Vereinigte Staaten, 77024
        • Memorial Hermann Memorial City Medical Center
      • League City, Texas, Vereinigte Staaten, 77573
        • UTMB Cancer Center at Victory Lakes
      • Lubbock, Texas, Vereinigte Staaten, 79410
        • Covenant Medical Center-Lakeside
      • Round Rock, Texas, Vereinigte Staaten, 78665
        • Texas Oncology-Seton Williamson
      • Round Rock, Texas, Vereinigte Staaten, 78681
        • Texas Oncology - Round Rock Cancer Center
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • University of Texas Health Science Center at San Antonio
      • Sugar Land, Texas, Vereinigte Staaten, 77479
        • Texas Oncology Cancer Center Sugar Land
      • Tyler, Texas, Vereinigte Staaten, 75702
        • Texas Oncology - Tyler
    • Utah
      • Logan, Utah, Vereinigte Staaten, 84321
        • Logan Regional Hospital
      • Murray, Utah, Vereinigte Staaten, 84107
        • Intermountain Medical Center
      • Ogden, Utah, Vereinigte Staaten, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, Vereinigte Staaten, 84604
        • Utah Valley Regional Medical Center
      • Salt Lake City, Utah, Vereinigte Staaten, 84112
        • Huntsman Cancer Institute/University of Utah
      • St. George, Utah, Vereinigte Staaten, 84770
        • Saint George Regional Medical Center
    • Vermont
      • Berlin Corners, Vermont, Vereinigte Staaten, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Vereinigte Staaten, 05401
        • University of Vermont Medical Center
      • Saint Johnsbury, Vermont, Vereinigte Staaten, 05819
        • Dartmouth Cancer Center - North
    • Virginia
      • Richmond, Virginia, Vereinigte Staaten, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98195
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, Vereinigte Staaten, 98133
        • FHCC at Northwest Hospital
      • Seattle, Washington, Vereinigte Staaten, 98133
        • FHCC Proton Therapy Center
      • Vancouver, Washington, Vereinigte Staaten, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, Vereinigte Staaten, 98684
        • Compass Oncology Vancouver
    • West Virginia
      • Wheeling, West Virginia, Vereinigte Staaten, 26003
        • Wheeling Hospital/Schiffler Cancer Center
    • Wisconsin
      • Antigo, Wisconsin, Vereinigte Staaten, 54409
        • Langlade Hospital and Cancer Center
      • La Crosse, Wisconsin, Vereinigte Staaten, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Vereinigte Staaten, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Menomonee Falls, Wisconsin, Vereinigte Staaten, 53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53226
        • Medical College of Wisconsin
      • Waukesha, Wisconsin, Vereinigte Staaten, 53188
        • UW Cancer Center at ProHealth Care
      • Wausau, Wisconsin, Vereinigte Staaten, 54401
        • Aspirus Regional Cancer Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

  • Age >= 18

  • 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

  • Patients 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Group 1 - Standard RT (Photon) (Arm A1)

Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Strahlung: Photon Beam Radiation Therapy

daily fractions

Andere Namen:
  • Photonen-EBRT
  • Photon Externe Strahlentherapie
  • Strahlung, Photonenstrahl
  • Externe Strahlentherapie mit Photonen (Verfahren)
  • Photon
  • PHOTON-Therapie
Arzneimittel: Temozolomide

tablet

Andere Namen:
  • Temodar
  • SCH52365
  • Temodal
  • Temcad
  • Methazolastein
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-carboxamid, 3,4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M und B 39831
  • Gliotem
  • Temizol
Aktiver Komparator: Group 2 - Standard RT (Proton) (Arm A2)

Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
Strahlung: Photon Beam Radiation Therapy

daily fractions

Andere Namen:
  • Photonen-EBRT
  • Photon Externe Strahlentherapie
  • Strahlung, Photonenstrahl
  • Externe Strahlentherapie mit Photonen (Verfahren)
  • Photon
  • PHOTON-Therapie
Arzneimittel: Temozolomide

tablet

Andere Namen:
  • Temodar
  • SCH52365
  • Temodal
  • Temcad
  • Methazolastein
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-carboxamid, 3,4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M und B 39831
  • Gliotem
  • Temizol
Experimental: Group 1 - Intensified RT (Photon) (Arm B)

Group 1 = Photon IMRT centers. 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 cycles in the absence of disease progression or unacceptable toxicity.
Strahlung: Photon Beam Radiation Therapy

daily fractions

Andere Namen:
  • Photonen-EBRT
  • Photon Externe Strahlentherapie
  • Strahlung, Photonenstrahl
  • Externe Strahlentherapie mit Photonen (Verfahren)
  • Photon
  • PHOTON-Therapie
Arzneimittel: Temozolomide

tablet

Andere Namen:
  • Temodar
  • SCH52365
  • Temodal
  • Temcad
  • Methazolastein
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-carboxamid, 3,4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M und B 39831
  • Gliotem
  • Temizol
Experimental: Group 2 - Intensified RT (Proton) (Arm C)

Group 2 = Proton centers. Participants undergo the same radiotherapy regimen described for Arm B but delivered using proton beam therapy. The elective target volume receives 50 Gy(RBE) in 30 fractions, and the boost target volume receives 75 Gy(RBE) in 30 fractions. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.
Arzneimittel: Temozolomide

tablet

Andere Namen:
  • Temodar
  • SCH52365
  • Temodal
  • Temcad
  • Methazolastein
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-carboxamid, 3,4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M und B 39831
  • Gliotem
  • Temizol
Strahlung: Proton Beam Radiation Therapy

Undergo dose-escalated and -intensified proton beam radiation therapy

Andere Namen:
  • Protonenstrahlentherapie
  • PBRT
  • Proton
  • Protonen-EBRT
  • Externe Strahlentherapie mit Protonen
  • Strahlung, Protonenstrahl
  • PROTONEN-Therapie
  • Externe Strahlentherapie Protonen (Verfahren)
  • Externe Strahlentherapie (Protonen)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Median Survival Time (Within Center Group)
Zeitfenster: Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.

Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers). Median survival times were estimated using the Kaplan-Meier method, censoring participants alive at the time of analysis. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers)
Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Median Survival Time (Between Experimental Arms)
Zeitfenster: Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.

Per the protocol, this outcome measure would be addressed only if both experimental (intensified RT) arms were statistically significantly different from their respective control (standard RT) arms, as defined in the primary outcome measure. If that condition were satisfied, the experimental (intensified RT) arms from each group would be compared with each other. Median survival times would be estimated using the Kaplan-Meier method, censoring participants alive at the time of analysis.
Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
Median Progression-free Survival Time
Zeitfenster: Randomization to progression, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.

Progression is defined as any of the following: ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration, with the treating institution encouraged to differentiate progression from pseudoprogression and radionecrosis using surgical resection, biopsy, and alternative imaging accordingly. Median progression-free survival times were estimated using the Kaplan-Meier method, censoring participants alive at the time of analysis. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Randomization to progression, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
Proportion of Participants With a Grade 3 or Higher Adverse Event
Zeitfenster: Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Proportions were estimated using an exact binomial distribution. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers)
Randomization to death or last follow-up. Median follow-up at time of analysis was 16.2 months for Group 1 and 18.3 months for Group 2.
Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score After Cycle 3
Zeitfenster: Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)

The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Cognitive Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)
Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score After Cycle 12
Zeitfenster: Baseline and end of cycle 12 of adjuvant temozolomide (approximately 60 weeks after start of chemoradiation)

The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Cognitive Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline. Comparisons occur between standard vs. intensified RT arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Baseline and end of cycle 12 of adjuvant temozolomide (approximately 60 weeks after start of chemoradiation)
Change From Baseline in the Clinical Trial Battery Composite Standardized Score at End of Cycle 3
Zeitfenster: Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)

The Clinical Trial Battery Composite Standardized Score is calculated as the arithmetic mean of multiple standardized neurocognitive test scores assessing memory, processing speed, executive function, and verbal fluency. Scores are standardized (z-scores) adjusted for age, education, and gender, with a mean of 0 and standard deviation of 1. A participant must have the majority of component scores available to calculate the composite. Possible scores are standardized z-scores that typically range from approximately -3 to +3, with higher scores indicating a better outcome. Change is calculated as time point minus baseline such that a positive change value indicates improvement and a negative change value indicates decline. Comparisons are made between standard-dose and intensified radiation therapy arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)
Change From Baseline in the Clinical Trial Battery Composite Standardized Score at End of Cycle 12
Zeitfenster: Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)

The Clinical Trial Battery Composite Standardized Score is calculated as the arithmetic mean of multiple standardized neurocognitive test scores assessing memory, processing speed, executive function, and verbal fluency. Scores are standardized (z-scores) adjusted for age, education, and gender, with a mean of 0 and standard deviation of 1. A participant must have the majority of component scores available to calculate the composite. Possible scores are standardized z-scores that typically range from approximately -3 to +3, with higher scores indicating a better outcome. Change is calculated as time point minus baseline such that a positive change value indicates improvement and a negative change value indicates decline. Comparisons are made between standard-dose and intensified radiation therapy arms within group (Group 1: photon IMRT centers; Group 2: proton centers).
Baseline and end of cycle 3 of adjuvant temozolomide (approximately 24 weeks after start of chemoradiation)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
CD4 Lymphopenia Count
Zeitfenster: Baseline to up to 5 years

Mean CD4 lymphopenia count change from baseline to each follow-up collection timepoint.
Baseline to up to 5 years
Use of Magnetic Resonance Diffusion and Perfusion Imaging to Differentiate Between Tumor Progression and Pseudo-progression
Zeitfenster: Baseline - cycle 4

Will be determined retrospectively following central review by an experienced neuro-radiologist blinded to the patient's outcome.
Baseline - cycle 4
Use of Magnetic Resonance Diffusion and Perfusion Imaging as Early Predictors of Overall Survival
Zeitfenster: Baseline up to 12 months

Cox proportional hazard model will be used to analyze the effect of imaging markers on overall survival. Known prognostic factors and patient baseline characteristics will be included in the multivariate analyses as covariates.
Baseline up to 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

NRG Oncology

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Minesh P Mehta, NRG Oncology

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. Dezember 2014

Primärer Abschluss (Tatsächlich)

7. Juli 2025

Studienabschluss (Geschätzt)

7. Juli 2030

Studienanmeldedaten

Zuerst eingereicht

27. Juni 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juni 2014

Zuerst gepostet (Geschätzt)

1. Juli 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NRG-BN001
  • U10CA180868 (US NIH Stipendium/Vertrag)
  • NRG-BN001 (Andere Kennung: CTEP)
  • NCI-2014-01072 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • P50CA127001 (US NIH Stipendium/Vertrag)
  • NRG-BN001 (Andere Kennung: NRG Oncology)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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