Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Dose-eskalert foton IMRT eller protonstrålebehandling versus standarddosestrålebehandling og temozolomid ved behandling av pasienter med nylig diagnostisert glioblastom

9. september 2026 oppdatert av: NRG Oncology

Randomisert fase II-studie av hypofraksjonert dose-eskalert foton IMRT eller protonstråleterapi versus konvensjonell fotonbestråling med samtidig og adjuvant temozolomid hos pasienter med nylig diagnostisert 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

624

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv 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.
Stråling: Photon Beam Radiation Therapy

daily fractions

Andre navn:
  • Foton EBRT
  • Foton ekstern strålebehandling
  • Stråling, fotonstråle
  • Ekstern strålebehandling med fotoner (prosedyre)
  • Foton
  • FOTON Terapi
Legemiddel: Temozolomide

tablet

Andre navn:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-karboksamid, 3,4-dihydro-3-metyl-4-okso-
  • M & B 39831
  • M og B 39831
  • Gliotem
  • Temizol
Aktiv 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.
Stråling: Photon Beam Radiation Therapy

daily fractions

Andre navn:
  • Foton EBRT
  • Foton ekstern strålebehandling
  • Stråling, fotonstråle
  • Ekstern strålebehandling med fotoner (prosedyre)
  • Foton
  • FOTON Terapi
Legemiddel: Temozolomide

tablet

Andre navn:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-karboksamid, 3,4-dihydro-3-metyl-4-okso-
  • M & B 39831
  • M og B 39831
  • Gliotem
  • Temizol
Eksperimentell: 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.
Stråling: Photon Beam Radiation Therapy

daily fractions

Andre navn:
  • Foton EBRT
  • Foton ekstern strålebehandling
  • Stråling, fotonstråle
  • Ekstern strålebehandling med fotoner (prosedyre)
  • Foton
  • FOTON Terapi
Legemiddel: Temozolomide

tablet

Andre navn:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-karboksamid, 3,4-dihydro-3-metyl-4-okso-
  • M & B 39831
  • M og B 39831
  • Gliotem
  • Temizol
Eksperimentell: 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.
Legemiddel: Temozolomide

tablet

Andre navn:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazin-8-karboksamid, 3,4-dihydro-3-metyl-4-okso-
  • M & B 39831
  • M og B 39831
  • Gliotem
  • Temizol
Stråling: Proton Beam Radiation Therapy

Undergo dose-escalated and -intensified proton beam radiation therapy

Andre navn:
  • Protonstrålebehandling
  • PBRT
  • Proton
  • Proton EBRT
  • Proton ekstern strålebehandling
  • Stråling, protonstråle
  • PROTON terapi
  • Eksterne strålebehandlingsprotoner (prosedyre)
  • Ekstern strålebehandling (protoner)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Median Survival Time (Within Center Group)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Median Survival Time (Between Experimental Arms)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
CD4 Lymphopenia Count
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

NRG Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Minesh P Mehta, NRG Oncology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. desember 2014

Primær fullføring (Faktiske)

7. juli 2025

Studiet fullført (Antatt)

7. juli 2030

Datoer for studieregistrering

Først innsendt

27. juni 2014

Først innsendt som oppfylte QC-kriteriene

27. juni 2014

Først lagt ut (Antatt)

1. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NRG-BN001
  • U10CA180868 (U.S. NIH-stipend/kontrakt)
  • NRG-BN001 (Annen identifikator: CTEP)
  • NCI-2014-01072 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • P50CA127001 (U.S. NIH-stipend/kontrakt)
  • NRG-BN001 (Annen identifikator: NRG Oncology)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere