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Фотонная IMRT или протонная лучевая терапия с увеличением дозы по сравнению со стандартной дозой лучевой терапии и темозоломидом при лечении пациентов с недавно диагностированной глиобластомой

9 сентября 2026 г. обновлено: NRG Oncology

Рандомизированное исследование фазы II гипофракционированной фотонной IMRT или протонной лучевой терапии в сравнении с традиционным фотонным облучением с сопутствующим и адъювантным темозоломидом у пациентов с недавно диагностированной глиобластомой

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.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

624

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: 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.
Радиация: Photon Beam Radiation Therapy

daily fractions

Другие имена:
  • Фотонная ДЛТ
  • Фотонная дистанционная лучевая терапия
  • Радиация, Фотонный Луч
  • Дистанционная лучевая терапия фотонами (процедура)
  • Фотон
  • ФОТОННАЯ ТЕРАПИЯ
Лекарство: Temozolomide

tablet

Другие имена:
  • Темодар
  • Щ 52365
  • Темодал
  • Темкад
  • Метазоластон
  • РП-46161
  • Темомедак
  • ТМЗ
  • CCRG-81045
  • Имидазо[5,1-d]-1,2,3,5-тетразин-8-карбоксамид, 3,4-дигидро-3-метил-4-оксо-
  • М&Б 39831
  • М и Б 39831
  • Глиотема
  • Темизол
Активный компаратор: 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.
Радиация: Photon Beam Radiation Therapy

daily fractions

Другие имена:
  • Фотонная ДЛТ
  • Фотонная дистанционная лучевая терапия
  • Радиация, Фотонный Луч
  • Дистанционная лучевая терапия фотонами (процедура)
  • Фотон
  • ФОТОННАЯ ТЕРАПИЯ
Лекарство: Temozolomide

tablet

Другие имена:
  • Темодар
  • Щ 52365
  • Темодал
  • Темкад
  • Метазоластон
  • РП-46161
  • Темомедак
  • ТМЗ
  • CCRG-81045
  • Имидазо[5,1-d]-1,2,3,5-тетразин-8-карбоксамид, 3,4-дигидро-3-метил-4-оксо-
  • М&Б 39831
  • М и Б 39831
  • Глиотема
  • Темизол
Экспериментальный: 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.
Радиация: Photon Beam Radiation Therapy

daily fractions

Другие имена:
  • Фотонная ДЛТ
  • Фотонная дистанционная лучевая терапия
  • Радиация, Фотонный Луч
  • Дистанционная лучевая терапия фотонами (процедура)
  • Фотон
  • ФОТОННАЯ ТЕРАПИЯ
Лекарство: Temozolomide

tablet

Другие имена:
  • Темодар
  • Щ 52365
  • Темодал
  • Темкад
  • Метазоластон
  • РП-46161
  • Темомедак
  • ТМЗ
  • CCRG-81045
  • Имидазо[5,1-d]-1,2,3,5-тетразин-8-карбоксамид, 3,4-дигидро-3-метил-4-оксо-
  • М&Б 39831
  • М и Б 39831
  • Глиотема
  • Темизол
Экспериментальный: 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.
Лекарство: Temozolomide

tablet

Другие имена:
  • Темодар
  • Щ 52365
  • Темодал
  • Темкад
  • Метазоластон
  • РП-46161
  • Темомедак
  • ТМЗ
  • CCRG-81045
  • Имидазо[5,1-d]-1,2,3,5-тетразин-8-карбоксамид, 3,4-дигидро-3-метил-4-оксо-
  • М&Б 39831
  • М и Б 39831
  • Глиотема
  • Темизол
Радиация: Proton Beam Radiation Therapy

Undergo dose-escalated and -intensified proton beam radiation therapy

Другие имена:
  • Протонная лучевая терапия
  • ПБРТ
  • Протон
  • Протонная дистанционная лучевая терапия
  • Радиация, протонный пучок
  • ПРОТОННАЯ терапия
  • Внешняя лучевая терапия протонами (процедура)
  • Внешняя лучевая терапия (протоны)

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Median Survival Time (Within Center Group)
Временное ограничение: 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.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Median Survival Time (Between Experimental Arms)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
CD4 Lymphopenia Count
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

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Спонсор

NRG Oncology

Соавторы

National Cancer Institute (NCI)

Следователи

  • Главный следователь: Minesh P Mehta, NRG Oncology

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

4 декабря 2014 г.

Первичное завершение (Действительный)

7 июля 2025 г.

Завершение исследования (Оцененный)

7 июля 2030 г.

Даты регистрации исследования

Первый отправленный

27 июня 2014 г.

Впервые представлено, что соответствует критериям контроля качества

27 июня 2014 г.

Первый опубликованный (Оцененный)

1 июля 2014 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • NRG-BN001
  • U10CA180868 (Грант/контракт NIH США)
  • NRG-BN001 (Другой идентификатор: CTEP)
  • NCI-2014-01072 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
  • P50CA127001 (Грант/контракт NIH США)
  • NRG-BN001 (Другой идентификатор: NRG Oncology)

Планирование данных отдельных участников (IPD)

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ДА

Описание плана 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.

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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