Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma

July 22, 2019 updated by: National Cancer Institute (NCI)

Phase III Double-blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to compare how well they work with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells and help kill them. It is not yet known whether temozolomide and radiation therapy are more effective when given together with or without bevacizumab in treating glioblastoma or gliosarcoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether the addition of bevacizumab to temozolomide and radiation improves efficacy as measured by progression-free and/or overall survival.

II. To assess the association between overall survival and K^trans change from T1 to T2. (ACRIN 6686) III. To assess the association between overall survival and spin echo cerebral blood volume (CBV) change from T1 to T2. (ACRIN 6686)

SECONDARY OBJECTIVES:

I. To determine whether the tumor molecular profile conferring a mesenchymal/angiogenic phenotype is associated with a selective increase in benefit, as measured by either overall survival or progression-free survival, from the addition of bevacizumab.

II. To compare and record the toxicities of the conventional and bevacizumab-containing regimens.

III. To assess the association between progression-free survival and K^trans change from T1 to T2. (ACRIN 6686) IV. To assess the association between progression-free survival and spin echo CBV change from T1 to T2. (ACRIN 6686) V. To assess the association between values of K^trans and spin echo CBV measured separately at T0 and at T1, and overall and progression-free survival. (ACRIN 6686) VI. To assess the association between overall survival and K^trans changes from T0 to T1 and from T2 to T3. (ACRIN 6686) VII. To assess the association between overall survival and spin echo CBV changes from T0 to T1 and from T2 to T3. (ACRIN 6686) VIII. To assess the association between overall survival and apparent diffusion coefficient (ADC) change from T0 to T1. (ACRIN 6686) IX. To assess the association between overall survival and ADC change from T1 to T2. (ACRIN 6686) X. To assess the association between progression-free survival and ADC change from T0 to T1. (ACRIN 6686) XI. To assess the association between progression-free survival and ADC change from T1 to T2. (ACRIN 6686) XII. To assess the association between T1 values of ADC and overall and progression-free survival. (ACRIN 6686) XIII. To assess the association between change in lesion size between T1 and T3, as measured by advanced magnetic resonance imaging (MRI), and overall and progression-free survival. (ACRIN 6686)

TERTIARY OBJECTIVES:

I. To determine the differential acute effects associated with the addition of bevacizumab to temozolomide and radiation, as compared to the conventional arm, on measures of neurocognitive function, health-related quality of life, and symptoms during radiation and across the longitudinal progression-free interval.

II. To determine the relationship of neurocognitive function, health-related quality of life, and symptoms, with progression-free and overall survival.

III. To determine the association between tumor molecular profile (i.e., mesenchymal/angiogenic phenotype and proneural phenotype) and neurocognitive function, health-related quality of life, and symptoms.

IV. To describe the association between health-related quality of life as measured by the European Organization for Research and Treatment Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTC-QL30/BCM20) and mean symptom severity as measured by the M. D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) in patients enrolled in this study.

V. To evaluate the relationship between self-reported neurocognitive function and objectively measured tests of neurocognitive function (NCF).

VI. To assess the association between measures of change in enhancing tumor size at week 22 and overall survival in participants with glioma receiving chemoradiotherapy with and without bevacizumab.

VII. To assess the association between measures of change in T2-based tumor size at week 22 and overall survival in participants with glioma receiving chemoradiotherapy with and without bevacizumab.

VIII. To assess the association between changes in ADC values and overall survival in participants with glioma receiving chemoradiotherapy with and without bevacizumab.

OUTLINE: Patients are randomized to 1 of 2 treatment arms (there are also two registration steps prior to randomization which are labeled as "arms" in ClinicalTrials.gov to facilitate entry of results into the website).

ARM I: Patients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks and receive temozolomide orally (PO) once daily (QD) for up to 7 weeks. Beginning 4 weeks after completion of chemotherapy and radiation therapy, patients receive temozolomide PO QD on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive placebo IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemotherapy and radiation therapy and continuing until the completion of temozolomide.

ARM II: Patients undergo radiation therapy and receive temozolomide as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemoradiotherapy and continuing until the completion of adjuvant temozolomide.

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.

Study Type

Interventional

Enrollment (Actual)

637

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Doctor H. Bliss Murphy Cancer Centre
    • Ontario
      • Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM - Hopital Notre-Dame
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University Department of Oncology
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • Israel
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Providence Hospital
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
      • Scottsdale, Arizona, United States, 85260
        • Arizona Oncology Services Foundation
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates-West Orange Grove
    • California
      • Auburn, California, United States, 95603
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Cameron Park, California, United States, 95682
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
      • Carmichael, California, United States, 95608
        • Mercy San Juan Medical Center
      • Concord, California, United States, 94520
        • John Muir Medical Center-Concord Campus
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Fresno, California, United States, 93720
        • Cancer Care Associates of Fresno Medical Group Inc
      • Fresno, California, United States, 93720
        • California Cancer Center - North Fresno
      • Fullerton, California, United States, 92835
        • Saint Jude Medical Center
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Oakland, California, United States, 94611
        • Kaiser Permanente Oakland-Broadway
      • Oakland, California, United States, 94609
        • Bay Area Tumor Institute
      • Orange, California, United States, 92868
        • Saint Joseph Hospital - Orange
      • Pomona, California, United States, 91767
        • Pomona Valley Hospital Medical Center
      • Rancho Cordova, California, United States, 95670
        • Kaiser Permanente-Rancho Cordova Cancer Center
      • Rohnert Park, California, United States, 94928
        • Rohnert Park Cancer Center
      • Roseville, California, United States, 95678
        • The Permanente Medical Group-Roseville Radiation Oncology
      • Roseville, California, United States, 95661
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
      • Sacramento, California, United States, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, United States, 95823
        • South Sacramento Cancer Center
      • Sacramento, California, United States, 95819
        • Mercy General Hospital Radiation Oncology Center
      • San Diego, California, United States, 92103
        • University of California San Diego
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente Cancer Treatment Center
      • Vacaville, California, United States, 95687
        • Sutter Cancer Centers Radiation Oncology Services-Vacaville
      • Walnut Creek, California, United States, 94598
        • John Muir Medical Center-Walnut Creek
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Saint Vincent's Medical Center
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • Norwich, Connecticut, United States, 06360
        • William Backus Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson Cancer Center
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
      • Jacksonville, Florida, United States, 32258
        • Baptist Medical Center South
      • Jacksonville, Florida, United States, 32207
        • Integrated Community Oncology Network-Southside Cancer Center
      • Jacksonville Beach, Florida, United States, 32250
        • Integrated Community Oncology Network-Florida Cancer Center Beaches
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orange Park, Florida, United States, 32073
        • 21st Century Oncology-Orange Park
      • Orlando, Florida, United States, 32803
        • Florida Hospital Orlando
      • Orlando, Florida, United States, 32806
        • UF Cancer Center at Orlando Health
      • Palatka, Florida, United States, 32177
        • 21st Century Oncology-Palatka
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital
      • Saint Augustine, Florida, United States, 32086
        • Integrated Community Oncology Network-Flager Cancer Center
      • Stuart, Florida, United States, 34994
        • Robert and Carol Weissman Cancer Center at Martin Health
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Columbus, Georgia, United States, 31904
        • John B Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Dekalb Medical Center
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center-Gainesville
      • Riverdale, Georgia, United States, 30274
        • Southern Regional Medical Center
      • Savannah, Georgia, United States, 31404
        • Memorial University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Community Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr Hospital of Cook County
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Moline, Illinois, United States, 61265
        • Trinity Medical Center
      • Naperville, Illinois, United States, 60540
        • Edward Hospital/Cancer Center
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
      • Peoria, Illinois, United States, 61603
        • Methodist Medical Center of Illinois
      • Springfield, Illinois, United States, 62781
        • Memorial Medical Center
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • IU Health Bloomington
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Hospital Randallia
      • Fort Wayne, Indiana, United States, 46804
        • Radiation Oncology Associates PC
      • Indianapolis, Indiana, United States, 46219
        • Community Cancer Center East
      • Indianapolis, Indiana, United States, 46256
        • Community Cancer Center North
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Hospital and Health Care Center
      • Indianapolis, Indiana, United States, 46219
        • IU Health Central Indiana Cancer Centers-East
      • Indianapolis, Indiana, United States, 46202
        • IU Health Methodist Hospital
      • Muncie, Indiana, United States, 47303
        • IU Health Ball Memorial Hospital
      • South Bend, Indiana, United States, 46628
        • Northern Indiana Cancer Research Consortium
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • Cedar Rapids, Iowa, United States, 52402
        • Physicians' Clinic of Iowa PC
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Mason City, Iowa, United States, 50401
        • Mercy Medical Center - North Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Prairie Village, Kansas, United States, 66208
        • Kansas City NCI Community Oncology Research Program
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • The James Graham Brown Cancer Center at University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center Jefferson
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University Health Sciences Center Shreveport
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Medical Center
      • Scarborough, Maine, United States, 04074
        • Maine Medical Center- Scarborough Campus
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, United States, 21229
        • Saint Agnes Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Fall River, Massachusetts, United States, 02721
        • Saint Anne's Hospital
      • Hyannis, Massachusetts, United States, 02601
        • Cape Cod Hospital
      • Lowell, Massachusetts, United States, 01854
        • Lowell General Hospital
      • Springfield, Massachusetts, United States, 01107
        • D'Amour Center for Cancer Care
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Dearborn, Michigan, United States, 48124
        • Beaumont Hospital-Dearborn
      • Detroit, Michigan, United States, 48236
        • Saint John Hospital and Medical Center
      • Flint, Michigan, United States, 48532
        • Genesys Regional Medical Center-West Flint Campus
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Royal Oak
      • Saginaw, Michigan, United States, 48601
        • Saint Mary's of Michigan
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Clinic North-Bemidgi
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • Saint Luke's Hospital of Duluth
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Singing River Hospital
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Cape Radiation Oncology
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center at West County Hospital
      • Kansas City, Missouri, United States, 64131
        • The University of Kansas Cancer Center-South
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center
      • Kansas City, Missouri, United States, 64154
        • The University of Kansas Cancer Center-North
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Saint Peters Hospital
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
    • Nebraska
      • Kearney, Nebraska, United States, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, United States, 68510
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68122
        • Alegent Health Immanuel Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Nevada Cancer Research Foundation CCOP
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Concord Hospital
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
      • Manchester, New Hampshire, United States, 03103
        • Elliot Hospital
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
      • Red Bank, New Jersey, United States, 07701
        • Riverview Medical Center/Booker Cancer Center
      • Sparta, New Jersey, United States, 07871
        • Sparta Cancer Treatment Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87102
        • Lovelace Medical Center-Downtown
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology Hematology Consultants
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology PC - Albany
      • Bronx, New York, United States, 10467-2490
        • Montefiore Medical Center - Moses Campus
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • Canandaigua, New York, United States, 14424
        • Sands Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Oceanside, New York, United States, 11572
        • South Nassau Communities
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Oncology Associates
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14620
        • Highland Hospital
      • Rochester, New York, United States, 14626
        • University Radiation Oncology
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital-Memorial Campus
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Hendersonville, North Carolina, United States, 28791
        • Margaret R Pardee Memorial Hospital
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth of the Carolinas-Moore Regional Hosiptal
      • Raleigh, North Carolina, United States, 27607
        • Duke Women's Cancer Care Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27104
        • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Akron, Ohio, United States, 44307
        • Akron General Medical Center
      • Barberton, Ohio, United States, 44203
        • Summa Barberton Hospital
      • Beachwood, Ohio, United States, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation
      • Canton, Ohio, United States, 44708
        • Mercy Medical Center
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati/Barrett Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center
      • Maumee, Ohio, United States, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, United States, 44060
        • Lake University Ireland Cancer Center
      • Middleburg Heights, Ohio, United States, 44130
        • Southwest General Health Center Ireland Cancer Center
      • Oregon, Ohio, United States, 43616
        • Saint Charles Hospital
      • Salem, Ohio, United States, 44460
        • Cancer Care Center, Incorporated
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Steubenville, Ohio, United States, 43952
        • Trinity's Tony Teramana Cancer Center
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital
      • Toledo, Ohio, United States, 43623
        • Mercy Saint Anne Hospital
      • West Chester, Ohio, United States, 45069
        • University Pointe
      • Westlake, Ohio, United States, 44145
        • UHHS-Westlake Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center at Saint Francis
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Center
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Salem, Oregon, United States, 97301
        • Salem Hospital
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Beaver, Pennsylvania, United States, 15009
        • UPMC-Heritage Valley Health System Beaver
      • Bethlehem, Pennsylvania, United States, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Dunmore, Pennsylvania, United States, 18512
        • Northeast Radiation Oncology Center
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Pocono Medical Center
      • Erie, Pennsylvania, United States, 16505
        • The Regional Cancer Center
      • Furlong, Pennsylvania, United States, 18925
        • Fox Chase Cancer Center Buckingham
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Greensburg, Pennsylvania, United States, 15601
        • UPMC Cancer Centers - Arnold Palmer Pavilion
      • Hanover, Pennsylvania, United States, 17331
        • Cherry Tree Cancer Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Johnstown, Pennsylvania, United States, 15901
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
      • Kittanning, Pennsylvania, United States, 16201
        • Armstrong Center for Medicine and Health
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • McKeesport, Pennsylvania, United States, 15132
        • UPMC Cancer Center at UPMC McKeesport
      • Monroeville, Pennsylvania, United States, 15146
        • Intercommunity Cancer Center
      • Natrona Heights, Pennsylvania, United States, 15065
        • Allegheny Valley Hospital
      • New Castle, Pennsylvania, United States, 16105
        • UPMC Jameson
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19114
        • Aria Health-Torresdale Campus
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC-Shadyside Hospital
      • Pittsburgh, Pennsylvania, United States, 15236
        • UPMC Jefferson Regional Radiation Oncology
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC-Passavant Hospital
      • Seneca, Pennsylvania, United States, 16346
        • UPMC Cancer Center at UPMC Northwest
      • Washington, Pennsylvania, United States, 15301
        • UPMC Washington Hospital Radiation Oncology
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center-Oncology Clinic
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
      • Jackson, Tennessee, United States, 38301
        • Jackson-Madison County General Hospital
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
    • Texas
      • Arlington, Texas, United States, 76014
        • Texas Oncology-Arlington South
      • Bedford, Texas, United States, 76022
        • Texas Oncology Bedford
      • Bryan, Texas, United States, 77802
        • Saint Joseph Regional Cancer Center
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, United States, 75237
        • Texas Oncology Methodist Charlton Cancer Center
      • Denton, Texas, United States, 76210
        • Texas Oncology-Denton South
      • Fort Worth, Texas, United States, 76104
        • The Klabzuba Cancer Center
      • Galveston, Texas, United States, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
      • Longview, Texas, United States, 75601
        • Texas Oncology-Longview Cancer Center
      • Lubbock, Texas, United States, 79410
        • Covenant Medical Center-Lakeside
      • Odessa, Texas, United States, 79761
        • West Texas Cancer Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
      • Sherman, Texas, United States, 75090
        • Texas Cancer Center-Sherman
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology Cancer Center Sugar Land
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Saint George, Utah, United States, 84770
        • Dixie Medical Center Regional Cancer Center
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Inova Alexandria Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Portsmouth, Virginia, United States, 23708-2197
        • Naval Medical Center - Portsmouth
    • Washington
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, United States, 98310
        • Harrison Medical Center
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98122-4307
        • Swedish Medical Center-First Hill
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
      • Vancouver, Washington, United States, 98684
        • Compass Oncology Vancouver
      • Yakima, Washington, United States, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
        • Wheeling Hospital/Schiffler Cancer Center
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • Appleton, Wisconsin, United States, 54911
        • Radiology Associates of Appleton/ThedaCare Regional Medical Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Eau Claire, Wisconsin, United States, 54701
        • Sacred Heart Hospital
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, United States, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, United States, 54301
        • Bellin Memorial Hospital
      • Johnson Creek, Wisconsin, United States, 53038
        • UW Cancer Center Johnson Creek
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Madison, Wisconsin, United States, 53717
        • Dean Hematology and Oncology Clinic
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and The Medical College of Wisconsin
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • Stevens Point, Wisconsin, United States, 54481
        • Saint Michael's Hospital
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • Weston, Wisconsin, United States, 54476
        • Diagnostic and Treatment Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus UW Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven diagnosis of glioblastoma or gliosarcoma (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 size for analysis of O-6-methylguanine-DNA methyltransferase (MGMT) and determination of molecular profile

    • Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged to maximize the chances of eligibility; at least 1 cubic centimeter of tissue composed primarily of tumor must be present
    • CUSA (Cavitron ultrasonic aspirator)-derived material is not allowed; fresh frozen tumor tissue acquisition is encouraged
    • Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis
    • The tumor tissue should be sent as soon as possible to maximize the likelihood of eligibility; tumor tissue should be submitted by 4 weeks after the surgical procedure so that the study registration and treatment can commence by the mandatory 5 week post-surgery outer limit
    • Sites must submit tissue fir central review in order to obtain the MGMT analysis; patients from sites not following protocol-specified process for obtaining MGMT results will be made ineligible
  • The tumor must have a supratentorial component
  • History/physical examination within 14 days prior to step 2 registration
  • The patient must have recovered from the effects of surgery, postoperative infection, and other complications before step 2 registration

  • A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy; the postoperative scan must be performed within 28 days prior to step 1 registration

    • An MRI or computed tomography (CT) scan (potentially in addition to the postoperative scan) must be obtained within 10 days prior to the start of radiation therapy and must not demonstrate significant postoperative hemorrhage defined as > 1 cm diameter of blood; if > 1 cm of acute blood is detected, the patient will be ineligible for this trial; the radiation planning MRI or CT scan may be used to determine presence of hemorrhage
    • Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and postoperative contrast-enhanced CT scans are obtained and are of sufficient quality; preoperative and postoperative scans must be the same type; such patients cannot be enrolled into the advanced imaging component
  • Documentation of steroid doses within 14 days prior to step 2 registration
  • Karnofsky performance status >= 70
  • Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 10.0 g/dL (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)
  • Blood urea nitrogen (BUN) =< 30 mg/dL within 14 days prior to step 2 registration
  • Creatinine =< 1.7 mg/dl within 14 days prior to step 2 registration
  • Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg
  • Bilirubin =< 2.0 mg/dl within 14 days prior to step 2 registration
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to step 2 registration
  • Systolic blood pressure =< 160 mg Hg or diastolic pressure =< 90 mm Hg within 14 days prior to step 2 registration
  • Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior to step 2 registration
  • Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 14 days prior to step 2 registration

  • Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:

    • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
    • In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of LMW heparin
  • Patient must provide study specific informed consent prior to study entry
  • Women of childbearing potential and male participants must practice adequate contraception
  • For females of child-bearing potential, negative serum pregnancy test within 14 days prior to step 2 registration

Exclusion Criteria:

  • Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years; (for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
  • Recurrent or multifocal malignant gliomas
  • Metastases detected below the tentorium or beyond the cranial vault
  • Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide or bevacizumab; 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 and/or congestive heart failure within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • 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 14 days of step 2 registration
    • New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
    • History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
    • Serious and inadequately controlled cardiac arrhythmia
    • Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease
    • Evidence of bleeding diathesis or coagulopathy
    • Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for tumor resection
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
    • 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
    • Any other major medical illnesses or psychiatric impairments 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
  • Pregnant or lactating women
  • Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study
  • For American College of Radiology Imaging Network (ACRIN) 6686 Advanced Imaging: inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (radiation therapy, temozolomide, placebo)
Patients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks and receive temozolomide PO QD for up to 7 weeks. Beginning 4 weeks after completion of chemotherapy and radiation therapy, patients receive temozolomide PO QD on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive placebo IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemotherapy and radiation therapy and continuing until the completion of temozolomide.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Placebo
Given IV
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy
Radiation: Intensity-Modulated Radiation Therapy
Undergo intensity-modulated radiation therapy
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Drug: Temozolomide
Given orally
Other Names:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Methazolastone
  • RP-46161
  • Temomedac
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3-dimentional conformal radiation therapy
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Experimental: Arm II (radiation therapy, temozolomide, bevacizumab)
Patients undergo radiation therapy and receive temozolomide as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemoradiotherapy and continuing until the completion of adjuvant temozolomide.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Biological: Bevacizumab
Given IV
Other Names:
  • Avastin
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF rhuMAb
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar FKB238
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
  • BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED
Radiation: Intensity-Modulated Radiation Therapy
Undergo intensity-modulated radiation therapy
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Drug: Temozolomide
Given orally
Other Names:
  • Temodar
  • SCH 52365
  • Temodal
  • Temcad
  • Methazolastone
  • RP-46161
  • Temomedac
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3-dimentional conformal radiation therapy
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.
Survival time was defined as time from randomization to date of death from any cause and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.
From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.
Progression-free Survival (PFS)
Time Frame: From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.
Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.
From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0
Time Frame: Up to 30 days
AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.
Up to 30 days

Other Outcome Measures

Outcome Measure
Time Frame
Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)
Time Frame: Analysis can occur at or after time of primary outcome measure analysis.
Analysis can occur at or after time of primary outcome measure analysis.
Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)
Time Frame: Analysis can occur at or after time of primary outcome measure analysis.
Analysis can occur at or after time of primary outcome measure analysis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

NRG Oncology
Radiation Therapy Oncology Group

Investigators

  • Principal Investigator: Mark Gilbert, NRG Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2009

Primary Completion (Actual)

March 17, 2013

Study Completion (Actual)

March 17, 2013

Study Registration Dates

First Submitted

April 18, 2009

First Submitted That Met QC Criteria

April 18, 2009

First Posted (Estimate)

April 21, 2009

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2009-01670 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180868 (U.S. NIH Grant/Contract)
  • U10CA021661 (U.S. NIH Grant/Contract)
  • RTOG-0825 (Other Identifier: CTEP)
  • RTOG 0825
  • CDR0000640428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe