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新たに診断された神経膠芽腫患者の治療における線量漸増光子 IMRT または陽子線放射線療法と標準線量放射線療法およびテモゾロミドとの比較

2026年9月9日 更新者：NRG Oncology

新たに診断された神経膠芽腫患者における同時および補助テモゾロミドによる低分割線量漸増光子 IMRT または陽子線治療と従来の光子照射の無作為化第 II 相試験

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

624

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
放射線：Photon Beam Radiation Therapy

daily fractions

他の名前：
  • フォトンEBRT
  • 光子外照射療法
  • 放射線、光子ビーム
  • 光子を用いた体外照射療法（手順）
  • 光子
  • フォトンセラピー
薬：Temozolomide

tablet

他の名前：
  • テモダール
  • SCH 52365
  • テモーダル
  • Temcad
  • メタゾラストン
  • RP-46161
  • テモメダク
  • TMZ
  • CCRG-81045
  • イミダゾ[5,1-d]-1,2,3,5-テトラジン-8-カルボキサミド、3,4-ジヒドロ-3-メチル-4-オキソ-
  • M&B 39831
  • エムアンドビー 39831
  • グリオテム
  • テミゾール
アクティブコンパレータ：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.
放射線：Photon Beam Radiation Therapy

daily fractions

他の名前：
  • フォトンEBRT
  • 光子外照射療法
  • 放射線、光子ビーム
  • 光子を用いた体外照射療法（手順）
  • 光子
  • フォトンセラピー
薬：Temozolomide

tablet

他の名前：
  • テモダール
  • SCH 52365
  • テモーダル
  • Temcad
  • メタゾラストン
  • RP-46161
  • テモメダク
  • TMZ
  • CCRG-81045
  • イミダゾ[5,1-d]-1,2,3,5-テトラジン-8-カルボキサミド、3,4-ジヒドロ-3-メチル-4-オキソ-
  • M&B 39831
  • エムアンドビー 39831
  • グリオテム
  • テミゾール
実験的：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.
放射線：Photon Beam Radiation Therapy

daily fractions

他の名前：
  • フォトンEBRT
  • 光子外照射療法
  • 放射線、光子ビーム
  • 光子を用いた体外照射療法（手順）
  • 光子
  • フォトンセラピー
薬：Temozolomide

tablet

他の名前：
  • テモダール
  • SCH 52365
  • テモーダル
  • Temcad
  • メタゾラストン
  • RP-46161
  • テモメダク
  • TMZ
  • CCRG-81045
  • イミダゾ[5,1-d]-1,2,3,5-テトラジン-8-カルボキサミド、3,4-ジヒドロ-3-メチル-4-オキソ-
  • M&B 39831
  • エムアンドビー 39831
  • グリオテム
  • テミゾール
実験的：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.
薬：Temozolomide

tablet

他の名前：
  • テモダール
  • SCH 52365
  • テモーダル
  • Temcad
  • メタゾラストン
  • RP-46161
  • テモメダク
  • TMZ
  • CCRG-81045
  • イミダゾ[5,1-d]-1,2,3,5-テトラジン-8-カルボキサミド、3,4-ジヒドロ-3-メチル-4-オキソ-
  • M&B 39831
  • エムアンドビー 39831
  • グリオテム
  • テミゾール
放射線：Proton Beam Radiation Therapy

Undergo dose-escalated and -intensified proton beam radiation therapy

他の名前：
  • 陽子線治療
  • PBRT
  • プロトン
  • プロトンEBRT
  • 陽子外照射療法
  • 放射線、陽子線
  • 外照射陽子線治療（手順）
  • 外照射療法（陽子線）

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Median Survival Time (Within Center Group)
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Median Survival Time (Between Experimental Arms)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

その他の成果指標

結果測定
メジャーの説明
時間枠
CD4 Lymphopenia Count
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

NRG Oncology

協力者

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Minesh P Mehta、NRG Oncology

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年12月4日

一次修了 (実際)

2025年7月7日

研究の完了 (推定)

2030年7月7日

試験登録日

最初に提出

2014年6月27日

QC基準を満たした最初の提出物

2014年6月27日

最初の投稿 (推定)

2014年7月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • NRG-BN001
  • U10CA180868 (米国 NIH グラント/契約)
  • NRG-BN001 (その他の識別子：CTEP)
  • NCI-2014-01072 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
  • P50CA127001 (米国 NIH グラント/契約)
  • NRG-BN001 (その他の識別子：NRG Oncology)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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