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剂量递增光子调强放疗或质子束放疗与标准剂量放疗和替莫唑胺治疗新诊断胶质母细胞瘤患者的对比

2026年8月6日更新者：NRG Oncology

大分割剂量递增光子 IMRT 或质子束疗法与常规光子照射联合替莫唑胺辅助治疗新诊断胶质母细胞瘤患者的随机 II 期试验

这项随机 II 期试验研究了剂量递增的光子强度调制放射疗法 (IMRT) 或质子束放射疗法与标准剂量放射疗法相比在新诊断的胶质母细胞瘤患者中使用替莫唑胺时的效果如何。放射治疗使用高能 X 射线和其他类型的辐射来杀死肿瘤细胞并缩小肿瘤。直接向肿瘤提供高剂量辐射的专门放射疗法可能会杀死更多的肿瘤细胞并减少对正常组织的损害。替莫唑胺等药物可能会使肿瘤细胞对放射治疗更敏感。目前尚不清楚剂量递增的光子 IMRT 或质子束放射疗法是否比使用替莫唑胺的标准剂量放射疗法在治疗胶质母细胞瘤方面更有效。

研究概览

地位

主动，不招人

条件

胶质母细胞瘤

干预/治疗

详细说明

主要目标：

I. 确定剂量递增和强化的光子 IMRT 或质子束疗法（使用每次剂量递增和同时整合增强）与伴随和辅助替莫唑胺相比，与标准剂量光子照射伴随伴随和辅助替莫唑胺。

次要目标：

I. 间接比较剂量递增和强化光子 IMRT 与剂量递增和强化质子束治疗的总生存率。

二。间接比较和记录剂量递增和强化光子 IMRT 与剂量递增和强化质子束治疗的毒性，并直接比较这些方法与伴随和辅助替莫唑胺主干的标准剂量光子照射的毒性。

三、确定剂量递增和强化的光子 IMRT 或质子束疗法（使用每次剂量递增和同时综合增强）与伴随和辅助替莫唑胺相比，与伴随标准剂量光子照射相比，是否改善感知认知症状的严重程度和辅助替莫唑胺。

四、确定剂量递增和强化的光子 IMRT 或质子束疗法（使用每次分次剂量递增，同时整合增强）与伴随和辅助替莫唑胺相比，与伴随和辅助的标准剂量光子照射相比，是否改善神经认知功能替莫唑胺。

V. 与剂量递增和强化光子 IMRT 相比，间接确定伴随和辅助替莫唑胺的剂量递增和强化质子束疗法是否改善认知症状严重程度，并直接比较这些方法与标准治疗的症状负担剂量光子照射伴随和辅助替莫唑胺的骨架。

六。间接确定与剂量递增和强化光子 IMRT 相比，剂量递增和强化质子束疗法联合辅助替莫唑胺是否能改善神经认知功能，并直接比较这些方法与标准剂量光子照射对神经认知功能的影响伴随和佐剂替莫唑胺的骨架。

三级目标：

I. 未来转化科学项目的组织库将根据报告主要终点时的科学状况确定，并将提交给国家癌症研究所 (NCI) 审查和批准。

二。前瞻性比较剂量递增和强化质子束治疗、剂量递增和强化光子 IMRT 以及标准剂量光子照射之间的 CD4 淋巴细胞减少，并确定 CD4 淋巴细胞减少是否影响总生存期。

三、探索最合适和临床相关的技术参数，以确保整个放射治疗过程的质量和有效性，包括成像、模拟、患者固定、目标和关键结构定义、治疗计划、图像引导和传送。

建立质量保证指南的可行性和临床相关性。
评估质量保证工具的功效。

四、探索最合适和临床相关的先进和标准 MRI 成像参数。

评估使用 MR 弥散和灌注成像在多机构环境中区分假性进展和真实进展的可行性。
评估反应和总体生存的早期成像生物标志物。

大纲：根据登记机构，患者被分配到 2 组中的 1 组。在每组中，患者将以 1:2 的比例随机分配到实验组。

第 I 组（光子 IMRT 中心）：患者被随机分配到 2 个治疗组中的 1 个。

ARM A1：患者使用 3 维适形放射疗法 (3D-CRT) 或每天一次 IMRT (QD) 进行标准剂量光子照射，每周 5 天，共 23 次，外加 7 次额外的剂量。

ARM B：患者接受剂量递增和强化的光子 IMRT QD，每周 5 天，共 30 次。

第 II 组（质子中心）：患者被随机分配到 2 个治疗组中的 1 个。

ARM A2：与 A1 组一样，患者使用 3D-CRT 或 IMRT 进行标准剂量光子照射。

ARM C：患者接受剂量递增和强化的质子束放射治疗 QD，每周 5 天，共 30 次。

在所有治疗组中，患者在放射治疗的第 1-49 天口服替莫唑胺 (PO) QD。 4 周后开始，患者在第 1-5 天接受替莫唑胺 PO QD。在没有疾病进展或不可接受的毒性的情况下，治疗每 28 天重复一次，最多 12 个周期。

完成研究治疗后，患者每 3 个月随访 1 年，每 4 个月随访 1 年，之后每 6 个月随访一次。

研究类型

介入性

注册 (实际的)

624

阶段

阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

在步骤 1 注册之前
必须在术后 72 小时内对大脑进行诊断性对比增强磁共振成像 (MRI)（不允许使用其他扫描类型）；增强肿瘤的最大直径必须为 5 厘米；肿瘤直径将是在对比增强术后 MRI 上测量的最大直径，并将包括残留病灶和/或适当的术后手术腔；对于无法识别残留疾病或术后手术腔的情况（例如，进行极叶切除术的极部胶质母细胞瘤 [GBM]），患者将被排除在试验之外
GBM肿瘤必须仅位于幕上隔室（不允许任何涉及脑干或小脑的成分）
患者必须在第 1 步注册之前提供研究特定的知情同意书
在第 2 步注册之前
胶质母细胞瘤的组织学诊断诊断（世界卫生组织 [WHO] IV 级）在第 2 步注册之前由中央审查确认
在第 2 步注册之前通过中央病理学审查确定的肿瘤组织数量足以分析 O6-甲基鸟嘌呤-DNA-甲基转移酶 (MGMT) 状态
- 患者必须至少有1块肿瘤组织；强烈建议提交 2 个区块，以最大限度地提高获得资格的机会；必须存在至少 1 立方厘米的主要由肿瘤组成的组织
- 诊断必须通过手术切除，部分或完全切除；不允许进行立体定向活检或空腔超声吸引器 (CUSA) 技术
步骤 2 注册前 28 天内的病史/体格检查
患者必须在第 2 步注册前 28 天内从手术、术后感染和其他并发症的影响中恢复过来
在第 2 步注册前 28 天内记录类固醇剂量
第 2 步注册前 28 天内的 Karnofsky 表现状态 >= 70
年龄 >= 18
中性粒细胞绝对计数 (ANC) >= 1,800 个细胞/mm^3
血小板 >= 100,000 个细胞/mm^3
血红蛋白 >= 10.0 g/dl（注意：使用输血或其他干预措施使血红蛋白 (Hgb) >= 10.0 g/dl 是可以接受的）
胆红素 =< 1.5 正常上限 (ULN)
丙氨酸转氨酶 (ALT) 和天冬氨酸转氨酶 (AST) =< 3 x ULN
在第 2 步注册前 28 天内为有生育能力的女性获得的阴性血清妊娠试验

排除标准：

既往侵袭性恶性肿瘤（非黑色素瘤性皮肤癌除外），除非至少 3 年无病；（例如，乳房、口腔或子宫颈的原位癌都是允许的）
复发性或多灶性恶性胶质瘤
远处疾病的任何部位（例如，从 GBM 肿瘤部位转移）
头颈部癌症的既往化疗或放射增敏剂；请注意，允许对不同的癌症进行先前的化疗（替莫唑胺除外）
不允许事先使用 Gliadel 晶片或任何其他瘤内或腔内治疗
先前对头部或颈部进行放射治疗（T1 声门癌除外），导致放射野重叠
严重的活动性合并症，定义如下：
- 第 2 步登记的不稳定型心绞痛
- 在第 2 步注册之前的最后 6 个月内发生透壁性心肌梗死
- 通过在第 2 步注册前 28 天内进行的心电图 (EKG) 分析，发现 S-T 升高 >= 2 毫米，从而证明近期心肌梗塞或缺血的证据
- 纽约心脏协会 II 级或更严重的充血性心力衰竭需要在第 2 步注册前 12 个月内住院
- 在第 2 步注册时严重且控制不当的心律失常
- 在第 2 步注册前 28 天内，严重或未愈合的伤口、溃疡或骨折或腹部瘘管病史、需要大手术的腹腔内脓肿、开放活检或重大外伤，但开颅手术除外
- 在第 2 步注册时需要静脉注射抗生素的急性细菌或真菌感染
- 导致临床黄疸和/或凝血缺陷的肝功能不全；但是请注意，加入本协议不需要凝血参数的实验室测试
- 在第 2 步注册时需要住院或排除研究治疗的慢性阻塞性肺疾病恶化或其他呼吸系统疾病
- 根据当前疾病控制和预防中心 (CDC) 的定义，获得性免疫缺陷综合症 (AIDS)；但请注意，加入本协议不需要进行人体免疫缺陷病毒 (HIV) 检测
- 任何其他严重的免疫功能低下情况
- 活动性结缔组织疾病，如狼疮或硬皮病，治疗医师认为可能会使患者面临辐射毒性的高风险
- 终末期肾病（即透析或已推荐透析）
- 研究者认为会妨碍实施或完成方案治疗的任何其他重大医学疾病或精神病学治疗
怀孕或有生育能力的妇女和性活跃但不愿意/不能使用医学上可接受的避孕方式的男性
在第 2 步注册前 30 天内按照任何其他临床治疗方案处理过的专利
无法接受 MRI（例如，出于安全原因，例如存在起搏器或严重的幽闭恐惧症）
术后肿瘤加手术床尺寸最大直径超过5cm。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：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.	辐射：Photon Beam Radiation Therapy daily fractions 其他名称：光子EBRT 光子外束放射治疗辐射，光子束使用光子进行外束放射治疗（程序）光子光子疗法药品：Temozolomide tablet 其他名称：特莫达尔 SCH 52365 泰莫达 Temcad软件甲唑司酮 RP-46161 特莫美达 TMZ CCRG-81045 咪唑并[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo- 并购 39831 M和B 39831 格利奥特姆替咪唑
有源比较器：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.	辐射：Photon Beam Radiation Therapy daily fractions 其他名称：光子EBRT 光子外束放射治疗辐射，光子束使用光子进行外束放射治疗（程序）光子光子疗法药品：Temozolomide tablet 其他名称：特莫达尔 SCH 52365 泰莫达 Temcad软件甲唑司酮 RP-46161 特莫美达 TMZ CCRG-81045 咪唑并[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo- 并购 39831 M和B 39831 格利奥特姆替咪唑
实验性的：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.	辐射：Photon Beam Radiation Therapy daily fractions 其他名称：光子EBRT 光子外束放射治疗辐射，光子束使用光子进行外束放射治疗（程序）光子光子疗法药品：Temozolomide tablet 其他名称：特莫达尔 SCH 52365 泰莫达 Temcad软件甲唑司酮 RP-46161 特莫美达 TMZ CCRG-81045 咪唑并[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo- 并购 39831 M和B 39831 格利奥特姆替咪唑
实验性的：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.	辐射：质子束辐射疗法接受剂量升级和强化的质子束辐射疗法其他名称：质子放射治疗 PBRT 质子质子EBRT 质子外照射治疗辐射，质子束质子治疗外束放射治疗质子（程序）外照射放射治疗（质子）药品：Temozolomide tablet 其他名称：特莫达尔 SCH 52365 泰莫达 Temcad软件甲唑司酮 RP-46161 特莫美达 TMZ CCRG-81045 咪唑并[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo- 并购 39831 M和B 39831 格利奥特姆替咪唑

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Median Survival Time (Within Center Group) 大体时间：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.

次要结果测量

结果测量	措施说明	大体时间
Median Survival Time (Between Experimental Arms) 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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)

其他结果措施

结果测量	措施说明	大体时间
CD4 Lymphopenia Count 大体时间：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 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

NRG Oncology

合作者

National Cancer Institute (NCI)

调查人员

首席研究员：Minesh P Mehta、NRG Oncology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年12月4日

初级完成 (实际的)

2025年7月7日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2014年6月27日

首先提交符合 QC 标准的

2014年6月27日

首次发布 (估计的)

2014年7月1日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月6日

最后验证

2026年6月1日

剂量递增光子调强放疗或质子束放疗与标准剂量放疗和替莫唑胺治疗新诊断胶质母细胞瘤患者的对比

大分割剂量递增光子 IMRT 或质子束疗法与常规光子照射联合替莫唑胺辅助治疗新诊断胶质母细胞瘤患者的随机 II 期试验

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

其他结果措施

结果测量

措施说明

大体时间

合作者和调查者

赞助

合作者

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明