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IMRT con fotone a dose aumentata o radioterapia con fascio di protoni rispetto alla radioterapia a dose standard e temozolomide nel trattamento di pazienti con glioblastoma di nuova diagnosi

9 settembre 2026 aggiornato da: NRG Oncology

Sperimentazione randomizzata di fase II di IMRT di fotoni con aumento della dose ipofrazionata o terapia con fascio di protoni rispetto all'irradiazione di fotoni convenzionale con temozolomide concomitante e adiuvante in pazienti con glioblastoma di nuova diagnosi

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.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Attivo, non reclutante

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Descrizione dettagliata

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.

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Interventistico

Iscrizione (Effettivo)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
624

Fase

Fase

La fase di una sperimentazione clinica che studia un farmaco o un prodotto biologico, sulla base delle definizioni sviluppate dalla Food and Drug Administration (FDA) statunitense. La fase si basa sull'obiettivo dello studio, sul numero di partecipanti e su altre caratteristiche. Ci sono cinque fasi: Early Phase 1 (precedentemente indicata come Fase 0), Phase 1, Phase 2, Phase 3 e Phase 4. Not Applicable è usato per descrivere sperimentazioni senza fasi definite dalla FDA, incluse sperimentazioni di dispositivi o interventi comportamentali.
  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm

Gruppo di partecipanti / Arm

Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Comparatore attivo: 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.
Radiazione: Photon Beam Radiation Therapy

daily fractions

Altri nomi:
  • Fotone EBRT
  • Radioterapia a fasci esterni di fotoni
  • Radiazione, Fascio Fotonico
  • Radioterapia a fasci esterni utilizzando fotoni (procedura)
  • Fotone
  • Terapia FOTONE
Droga: Temozolomide

tablet

Altri nomi:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazina-8-carbossammide, 3,4-diidro-3-metil-4-osso-
  • M&B 39831
  • M e B 39831
  • Gliotem
  • Temizolo
Comparatore attivo: 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.
Radiazione: Photon Beam Radiation Therapy

daily fractions

Altri nomi:
  • Fotone EBRT
  • Radioterapia a fasci esterni di fotoni
  • Radiazione, Fascio Fotonico
  • Radioterapia a fasci esterni utilizzando fotoni (procedura)
  • Fotone
  • Terapia FOTONE
Droga: Temozolomide

tablet

Altri nomi:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazina-8-carbossammide, 3,4-diidro-3-metil-4-osso-
  • M&B 39831
  • M e B 39831
  • Gliotem
  • Temizolo
Sperimentale: 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.
Radiazione: Photon Beam Radiation Therapy

daily fractions

Altri nomi:
  • Fotone EBRT
  • Radioterapia a fasci esterni di fotoni
  • Radiazione, Fascio Fotonico
  • Radioterapia a fasci esterni utilizzando fotoni (procedura)
  • Fotone
  • Terapia FOTONE
Droga: Temozolomide

tablet

Altri nomi:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazina-8-carbossammide, 3,4-diidro-3-metil-4-osso-
  • M&B 39831
  • M e B 39831
  • Gliotem
  • Temizolo
Sperimentale: 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.
Droga: Temozolomide

tablet

Altri nomi:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Metazolastone
  • RP-46161
  • Temomedac
  • TMZ
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazina-8-carbossammide, 3,4-diidro-3-metil-4-osso-
  • M&B 39831
  • M e B 39831
  • Gliotem
  • Temizolo
Radiazione: Proton Beam Radiation Therapy

Undergo dose-escalated and -intensified proton beam radiation therapy

Altri nomi:
  • Radioterapia protonica
  • PBR
  • Protone
  • Protone EBRT
  • Radioterapia a fasci esterni di protoni
  • Radiazione, fascio di protoni
  • Terapia PROTON
  • Protoni per radioterapia a fascio esterno (procedura)
  • Radioterapia a fasci esterni (protoni)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Median Survival Time (Within Center Group)
Lasso di tempo: 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.

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
Median Survival Time (Between Experimental Arms)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Altre misure di risultato

Altre misure di risultato

Per gli studi clinici, una misurazione pianificata descritta nel protocollo utilizzata per determinare l'effetto di un intervento/trattamento sui partecipanti. Per gli studi osservazionali, una misurazione o un'osservazione utilizzata per descrivere modelli di malattie o tratti o associazioni con esposizioni, fattori di rischio o trattamento. I tipi di misure di esito includono la misura dell'esito primario e la misura dell'esito secondario.
Misura del risultato
Misura Descrizione
Lasso di tempo
CD4 Lymphopenia Count
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
NRG Oncology

Collaboratori

Collaboratori

Un'organizzazione diversa dallo sponsor che fornisce supporto per uno studio clinico. Questo supporto può includere attività relative al finanziamento, alla progettazione, all'implementazione, all'analisi dei dati o al reporting.
National Cancer Institute (NCI)

Investigatori

Investigatori

Un ricercatore coinvolto in uno studio clinico. I termini correlati includono il ricercatore principale del sito, il ricercatore secondario del sito, il presidente dello studio, il direttore dello studio e il ricercatore principale dello studio.
  • Investigatore principale: Minesh P Mehta, NRG Oncology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
4 dicembre 2014

Completamento primario (Effettivo)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
7 luglio 2025

Completamento dello studio (Stimato)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
7 luglio 2030

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
27 giugno 2014

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
27 giugno 2014

Primo Inserito (Stimato)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
1 luglio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
9 settembre 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • NRG-BN001
  • U10CA180868 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NRG-BN001 (Altro identificatore: CTEP)
  • NCI-2014-01072 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • P50CA127001 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NRG-BN001 (Altro identificatore: NRG Oncology)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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