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Dosis-geëscaleerde foton-IMRT of protonenbeam-stralingstherapie versus standaarddosis-stralingstherapie en temozolomide bij de behandeling van patiënten met een nieuw gediagnosticeerd glioblastoom

9 september 2026 bijgewerkt door: NRG Oncology

Gerandomiseerde fase II-studie van gehypofractioneerde dosis-geëscaleerde fotonen-IMRT of protonenbundeltherapie versus conventionele fotonenbestraling met gelijktijdige en adjuvante temozolomide bij patiënten met nieuw gediagnosticeerd glioblastoom

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

624

Fase

  • Fase 2

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Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Straling: Photon Beam Radiation Therapy

daily fractions

Andere namen:
  • Foton EBRT
  • Photon External Beam Radiotherapie
  • Straling, fotonenstraal
  • Externe radiotherapie met behulp van fotonen (procedure)
  • Foton
  • FOTON-therapie
Geneesmiddel: Temozolomide

tablet

Andere namen:
  • Temodar
  • SCH 52365
  • Temodaal
  • Temcad
  • Methazolasteen
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M en B 39831
  • Glioteem
  • Temizol
Actieve vergelijker: 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.
Straling: Photon Beam Radiation Therapy

daily fractions

Andere namen:
  • Foton EBRT
  • Photon External Beam Radiotherapie
  • Straling, fotonenstraal
  • Externe radiotherapie met behulp van fotonen (procedure)
  • Foton
  • FOTON-therapie
Geneesmiddel: Temozolomide

tablet

Andere namen:
  • Temodar
  • SCH 52365
  • Temodaal
  • Temcad
  • Methazolasteen
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M en B 39831
  • Glioteem
  • Temizol
Experimenteel: 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.
Straling: Photon Beam Radiation Therapy

daily fractions

Andere namen:
  • Foton EBRT
  • Photon External Beam Radiotherapie
  • Straling, fotonenstraal
  • Externe radiotherapie met behulp van fotonen (procedure)
  • Foton
  • FOTON-therapie
Geneesmiddel: Temozolomide

tablet

Andere namen:
  • Temodar
  • SCH 52365
  • Temodaal
  • Temcad
  • Methazolasteen
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M en B 39831
  • Glioteem
  • Temizol
Experimenteel: 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.
Geneesmiddel: Temozolomide

tablet

Andere namen:
  • Temodar
  • SCH 52365
  • Temodaal
  • Temcad
  • Methazolasteen
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M en B 39831
  • Glioteem
  • Temizol
Straling: Proton Beam Radiation Therapy

Undergo dose-escalated and -intensified proton beam radiation therapy

Andere namen:
  • Protonenbestralingstherapie
  • PBRT
  • Proton
  • Proton EBRT
  • Proton Externe Beam Radiotherapie
  • Straling, protonenbundel
  • PROTON-therapie
  • Externe bestralingstherapie protonen (procedure)
  • Externe Beam Radiotherapie (protonen)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Median Survival Time (Within Center Group)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Median Survival Time (Between Experimental Arms)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
CD4 Lymphopenia Count
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

NRG Oncology

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Minesh P Mehta, NRG Oncology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 december 2014

Primaire voltooiing (Werkelijk)

7 juli 2025

Studie voltooiing (Geschat)

7 juli 2030

Studieregistratiedata

Eerst ingediend

27 juni 2014

Eerst ingediend dat voldeed aan de QC-criteria

27 juni 2014

Eerst geplaatst (Geschat)

1 juli 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NRG-BN001
  • U10CA180868 (Subsidie/contract van de Amerikaanse NIH)
  • NRG-BN001 (Andere identificatie: CTEP)
  • NCI-2014-01072 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • P50CA127001 (Subsidie/contract van de Amerikaanse NIH)
  • NRG-BN001 (Andere identificatie: NRG Oncology)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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