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Zwiększona dawka fotonowej IMRT lub radioterapii wiązką protonową w porównaniu z radioterapią standardową dawką i temozolomidem w leczeniu pacjentów z nowo zdiagnozowanym glejakiem

9 września 2026 zaktualizowane przez: NRG Oncology

Randomizowane badanie fazy II hipofrakcjonowanej hipofrakcjonowanej fotonowej IMRT lub terapii wiązką protonową w porównaniu z konwencjonalnym napromieniowaniem fotonowym w skojarzeniu z temozolomidem w leczeniu uzupełniającym u pacjentów z nowo rozpoznanym glejakiem

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Glejaka wielopostaciowego

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

624

Faza

Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Randomizowane
Model interwencyjny: Przydział równoległy
Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm Grupa uczestników / Arm Grupa lub podgrupa uczestników badania klinicznego, którzy zgodnie z protokołem badania otrzymują określoną interwencję/leczenie lub nie otrzymują żadnej interwencji.	Interwencja / Leczenie Interwencja / Leczenie Proces lub działanie będące przedmiotem badania klinicznego. Interwencje obejmują leki, urządzenia medyczne, procedury, szczepionki i inne produkty, które są w fazie badań lub są już dostępne. Interwencje mogą również obejmować podejścia nieinwazyjne, takie jak edukacja lub modyfikacja diety i ćwiczeń.
Aktywny komparator: Group 1 - Standard RT (Photon) (Arm A1) Group 1 = Photon IMRT centers. Participants undergo standard-dose postoperative photon radiotherapy using 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) administered once daily, 5 days per week. Treatment consists of 46 Gy in 23 fractions followed by a sequential boost to a total dose of 60 Gy in 30 fractions. Participants receive concurrent temozolomide orally once daily during radiotherapy for up to 49 days and adjuvant temozolomide orally once daily on days 1-5 of each 28-day cycle for up to 12 cycles in the absence of disease progression or unacceptable toxicity.	Promieniowanie: Photon Beam Radiation Therapy daily fractions Inne nazwy: Foton EBRT Fotonowa radioterapia wiązkami zewnętrznymi Promieniowanie, wiązka fotonów Radioterapia wiązkami zewnętrznymi fotonami (zabieg) Foton Terapia FOTONOWA Lek: Temozolomide tablet Inne nazwy: Temodara SCH 52365 Temodal Temcad Metazolaston RP-46161 Temomedak TMZ CCRG-81045 Imidazo[5,1-d]-1,2,3,5-tetrazyno-8-karboksyamid, 3,4-dihydro-3-metylo-4-okso- M&B 39831 M i B 39831 Gliotem Temizol
Aktywny komparator: Group 2 - Standard RT (Proton) (Arm A2) Group 2 = Proton centers. Participants undergo the same standard-dose postoperative radiotherapy regimen described for Arm A1 but delivered using proton beam therapy. Participants receive concurrent and adjuvant temozolomide as described for Arm A1.	Promieniowanie: Photon Beam Radiation Therapy daily fractions Inne nazwy: Foton EBRT Fotonowa radioterapia wiązkami zewnętrznymi Promieniowanie, wiązka fotonów Radioterapia wiązkami zewnętrznymi fotonami (zabieg) Foton Terapia FOTONOWA Lek: Temozolomide tablet Inne nazwy: Temodara SCH 52365 Temodal Temcad Metazolaston RP-46161 Temomedak TMZ CCRG-81045 Imidazo[5,1-d]-1,2,3,5-tetrazyno-8-karboksyamid, 3,4-dihydro-3-metylo-4-okso- M&B 39831 M i B 39831 Gliotem Temizol
Eksperymentalny: 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.	Promieniowanie: Photon Beam Radiation Therapy daily fractions Inne nazwy: Foton EBRT Fotonowa radioterapia wiązkami zewnętrznymi Promieniowanie, wiązka fotonów Radioterapia wiązkami zewnętrznymi fotonami (zabieg) Foton Terapia FOTONOWA Lek: Temozolomide tablet Inne nazwy: Temodara SCH 52365 Temodal Temcad Metazolaston RP-46161 Temomedak TMZ CCRG-81045 Imidazo[5,1-d]-1,2,3,5-tetrazyno-8-karboksyamid, 3,4-dihydro-3-metylo-4-okso- M&B 39831 M i B 39831 Gliotem Temizol
Eksperymentalny: 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.	Lek: Temozolomide tablet Inne nazwy: Temodara SCH 52365 Temodal Temcad Metazolaston RP-46161 Temomedak TMZ CCRG-81045 Imidazo[5,1-d]-1,2,3,5-tetrazyno-8-karboksyamid, 3,4-dihydro-3-metylo-4-okso- M&B 39831 M i B 39831 Gliotem Temizol Promieniowanie: Proton Beam Radiation Therapy Undergo dose-escalated and -intensified proton beam radiation therapy Inne nazwy: Terapia promieniowaniem protonowym PBRT Proton Protonowy EBRT Protonowa radioterapia wiązką zewnętrzną Promieniowanie, wiązka protonów Terapia PROTONOWA Protonowa radioterapia wiązką zewnętrzną (zabieg) Radioterapia wiązką zewnętrzną (protony)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Median Survival Time (Within Center Group) Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Median Survival Time (Between Experimental Arms) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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)

Inne miary wyników

Miara wyniku	Opis środka	Ramy czasowe
CD4 Lymphopenia Count Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

NRG Oncology

Współpracownicy

National Cancer Institute (NCI)

Śledczy

Główny śledczy: Minesh P Mehta, NRG Oncology

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 grudnia 2014

Zakończenie podstawowe (Rzeczywisty)

7 lipca 2025

Ukończenie studiów (Szacowany)

7 lipca 2030

Daty rejestracji na studia

Pierwszy przesłany

27 czerwca 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 czerwca 2014

Pierwszy wysłany (Szacowany)

1 lipca 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

NRG-BN001
U10CA180868 (Grant/umowa NIH USA)
NRG-BN001 (Inny identyfikator: CTEP)
NCI-2014-01072 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
P50CA127001 (Grant/umowa NIH USA)
NRG-BN001 (Inny identyfikator: NRG Oncology)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Zwiększona dawka fotonowej IMRT lub radioterapii wiązką protonową w porównaniu z radioterapią standardową dawką i temozolomidem w leczeniu pacjentów z nowo zdiagnozowanym glejakiem

Randomizowane badanie fazy II hipofrakcjonowanej hipofrakcjonowanej fotonowej IMRT lub terapii wiązką protonową w porównaniu z konwencjonalnym napromieniowaniem fotonowym w skojarzeniu z temozolomidem w leczeniu uzupełniającym u pacjentów z nowo rozpoznanym glejakiem

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Szczegółowy opis

Typ studiów

Zapisy (Rzeczywisty)

Faza

Kontakty i lokalizacje

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Płeć kwalifikująca się do nauki

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Opis środka

Ramy czasowe

Inne miary wyników

Miara wyniku

Opis środka

Ramy czasowe

Współpracownicy i badacze

Sponsor

Współpracownicy

Śledczy

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

Zakończenie podstawowe (Rzeczywisty)

Ukończenie studiów (Szacowany)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Szacowany)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Opis planu IPD