Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Who is this study for? Patients with Brain and Central Nervous System Tumors
Status: Recruiting
Location: See all (278) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ United States (US) and Canadian sites:

• This review is mandatory prior to registration to confirm eligibility; patients must be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible

⁃ Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review

⁃ Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility, the 1p/19q analysis results will be accepted from the local site, as determined by either a locally available or reference laboratory (for US, must be Clinical Laboratory Improvement Act [CLIA] certified); acceptable methods for determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by genomic sequencing or methylomic analyses; US and Canadian sites must send a copy of the official report to the pathology coordinator and quality assurance specialist (QAS)

⁃ Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic analyses; this should be performed at the local site (US: performed in a CLIA certified laboratory); the site must send a copy of the official report to the pathology coordinator and QAS

⁃ Newly diagnosed and =< 3 months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure > 3 months earlier for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy

⁃ Histological evidence of World Health Organization (WHO) grade III anaplastic glioma or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced laboratory qualified for the study

• Note: mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q

⁃ Patients with codeleted low grade gliomas must also be considered high risk by exhibiting one or more of the following characteristics:

⁃ Age >= 40 and any surgical therapy

⁃ Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)

⁃ Documented growth following prior surgery (NOTE: patients with prior surgery cannot have received prior radiation, chemotherapy or targeted therapy)

⁃ Intractable seizures

⁃ Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery

⁃ Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to registration

⁃ Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration

⁃ Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration

⁃ Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registration

⁃ Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN obtained =< 21 days prior to registration

⁃ Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration

⁃ Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only

⁃ Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance)

⁃ Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2

⁃ Written informed consent

⁃ Willingness to return to enrolling institution for follow-up during the active monitoring phase (that is, the active treatment and observation portion) of the study); patients who have been formally transferred to another active and approved site participating in this study would not need to return to the enrolling institution for this purpose

⁃ Willingness to allow the provision of tissue samples for correlative research, as long as adequate tissues are available; patients will not be excluded from participation in the study, if they are willing to allow provision of tissues for the correlative research, but there are insufficient quantities of tissue for the correlative analyses (e.g., a patient otherwise eligible and willing who had biopsy only) Willingness to allow the provision of blood samples for correlative research; patients are not excluded from participation in the study, if they are willing to provide the mandatory biospecimens for translational/correlative research, but for logistical reasons the specimens(s) were not obtainable or if the volume collected was insufficient

Locations
United States
Alaska
Alaska Oncology and Hematology LLC
Suspended
Anchorage
Alaska Women's Cancer Care
Suspended
Anchorage
Anchorage Associates in Radiation Medicine
Suspended
Anchorage
Anchorage Oncology Centre
Suspended
Anchorage
Katmai Oncology Group
Suspended
Anchorage
Providence Alaska Medical Center
Recruiting
Anchorage
Alabama
University of Alabama at Birmingham Cancer Center
Active, not recruiting
Birmingham
Providence Hospital
Suspended
Mobile
Arizona
Arizona Oncology-Deer Valley Center
Suspended
Phoenix
Saint Joseph's Hospital and Medical Center
Suspended
Phoenix
Arizona Oncology Services Foundation
Suspended
Scottsdale
California
Kaiser Permanente-Anaheim
Recruiting
Anaheim
Sutter Cancer Centers Radiation Oncology Services-Auburn
Suspended
Auburn
Mills-Peninsula Medical Center
Suspended
Burlingame
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Suspended
Cameron Park
Community Cancer Institute
Recruiting
Clovis
University Oncology Associates
Recruiting
Clovis
UC San Diego Moores Cancer Center
Recruiting
La Jolla
Cedars Sinai Medical Center
Active, not recruiting
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Recruiting
Los Angeles
Memorial Medical Center
Suspended
Modesto
Kaiser Permanente Oakland-Broadway
Suspended
Oakland
Kaiser Permanente-Ontario
Recruiting
Ontario
UC Irvine Health/Chao Family Comprehensive Cancer Center
Recruiting
Orange
Sutter Cancer Centers Radiation Oncology Services-Roseville
Recruiting
Roseville
Sutter Roseville Medical Center
Suspended
Roseville
Sutter Medical Center Sacramento
Recruiting
Sacramento
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Kaiser Permanente Medical Center - Santa Clara
Suspended
Santa Clara
Kaiser Permanente-South San Francisco
Suspended
South San Francisco
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Suspended
Vacaville
Sutter Solano Medical Center/Cancer Center
Suspended
Vallejo
Colorado
The Medical Center of Aurora
Active, not recruiting
Aurora
University of Colorado Hospital
Active, not recruiting
Aurora
Penrose-Saint Francis Healthcare
Recruiting
Colorado Springs
UCHealth Memorial Hospital Central
Active, not recruiting
Colorado Springs
Porter Adventist Hospital
Recruiting
Denver
Saint Anthony Hospital
Suspended
Lakewood
Littleton Adventist Hospital
Recruiting
Littleton
Longmont United Hospital
Recruiting
Longmont
McKee Medical Center
Suspended
Loveland
Parker Adventist Hospital
Recruiting
Parker
Saint Mary Corwin Medical Center
Recruiting
Pueblo
Connecticut
Yale University
Recruiting
New Haven
Smilow Cancer Hospital Care Center-Trumbull
Recruiting
Trumbull
Washington, D.c.
Sibley Memorial Hospital
Recruiting
Washington
Florida
Boca Raton Regional Hospital
Recruiting
Boca Raton
University of Florida Health Science Center - Gainesville
Active, not recruiting
Gainesville
Baptist MD Anderson Cancer Center
Recruiting
Jacksonville
Mayo Clinic in Florida
Suspended
Jacksonville
AdventHealth Orlando
Recruiting
Orlando
Georgia
Emory Proton Therapy Center
Recruiting
Atlanta
Emory University Hospital Midtown
Recruiting
Atlanta
Emory University Hospital/Winship Cancer Institute
Recruiting
Atlanta
Piedmont Hospital
Suspended
Atlanta
Iowa
McFarland Clinic PC - Ames
Recruiting
Ames
Medical Oncology and Hematology Associates-West Des Moines
Suspended
Clive
Mercy Cancer Center-West Lakes
Recruiting
Clive
Greater Regional Medical Center
Recruiting
Creston
Broadlawns Medical Center
Suspended
Des Moines
Iowa Lutheran Hospital
Suspended
Des Moines
Iowa Methodist Medical Center
Recruiting
Des Moines
Medical Oncology and Hematology Associates-Des Moines
Suspended
Des Moines
Medical Oncology and Hematology Associates-Laurel
Suspended
Des Moines
Mercy Medical Center - Des Moines
Recruiting
Des Moines
Mercy Medical Center-West Lakes
Suspended
West Des Moines
Methodist West Hospital
Suspended
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Caldwell
Recruiting
Caldwell
Kootenai Clinic Cancer Services - Post Falls
Suspended
Post Falls
Illinois
Illinois CancerCare-Bloomington
Recruiting
Bloomington
Illinois CancerCare-Canton
Recruiting
Canton
Illinois CancerCare-Carthage
Recruiting
Carthage
Centralia Oncology Clinic
Suspended
Centralia
Northwestern University
Active, not recruiting
Chicago
University of Chicago Comprehensive Cancer Center
Suspended
Chicago
Cancer Care Specialists of Illinois - Decatur
Suspended
Decatur
Decatur Memorial Hospital
Recruiting
Decatur
Crossroads Cancer Center
Suspended
Effingham
Illinois CancerCare-Eureka
Recruiting
Eureka
Illinois CancerCare-Galesburg
Recruiting
Galesburg
Western Illinois Cancer Treatment Center
Suspended
Galesburg
Illinois CancerCare-Kewanee Clinic
Recruiting
Kewanee
AMITA Health Adventist Medical Center
Active, not recruiting
La Grange
Illinois CancerCare-Macomb
Recruiting
Macomb
Loyola University Medical Center
Recruiting
Maywood
Cancer Care Center of O'Fallon
Suspended
O'fallon
Illinois CancerCare-Ottawa Clinic
Recruiting
Ottawa
Advocate Lutheran General Hospital
Active, not recruiting
Park Ridge
Illinois CancerCare-Pekin
Recruiting
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Recruiting
Pekin
Illinois CancerCare-Peoria
Recruiting
Peoria
Methodist Medical Center of Illinois
Suspended
Peoria
OSF Saint Francis Medical Center
Recruiting
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Recruiting
Peoria
Illinois CancerCare-Peru
Recruiting
Peru
Valley Radiation Oncology
Suspended
Peru
Illinois CancerCare-Princeton
Recruiting
Princeton
Memorial Medical Center
Recruiting
Springfield
Indiana
Parkview Hospital Randallia
Active, not recruiting
Fort Wayne
Parkview Regional Medical Center
Active, not recruiting
Fort Wayne
Memorial Regional Cancer Center Day Road
Suspended
Mishawaka
Memorial Hospital of South Bend
Suspended
South Bend
Kansas
University of Kansas Cancer Center
Recruiting
Kansas City
University of Kansas Cancer Center-Overland Park
Recruiting
Overland Park
University of Kansas Hospital-Indian Creek Campus
Recruiting
Overland Park
University of Kansas Hospital-Westwood Cancer Center
Recruiting
Westwood
Kentucky
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Norton Brownsboro Hospital and Medical Campus
Recruiting
Louisville
Norton Hospital Pavilion and Medical Campus
Recruiting
Louisville
Louisiana
West Jefferson Medical Center
Recruiting
Marrero
Massachusetts
Massachusetts General Hospital Cancer Center
Suspended
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Recruiting
Baltimore
Walter Reed National Military Medical Center
Recruiting
Bethesda
Cancer Trials Support Unit
Recruiting
Rockville
Maine
Maine Medical Center-Bramhall Campus
Active, not recruiting
Portland
Maine Medical Center- Scarborough Campus
Recruiting
Scarborough
Maine Medical Partners Neurology
Suspended
Scarborough
Maine Medical Partners - South Portland
Suspended
South Portland
Michigan
Bixby Medical Center
Active, not recruiting
Adrian
University of Michigan Comprehensive Cancer Center
Recruiting
Ann Arbor
Henry Ford Hospital
Active, not recruiting
Detroit
Mercy Health Saint Mary's
Suspended
Grand Rapids
Spectrum Health at Butterworth Campus
Suspended
Grand Rapids
West Michigan Cancer Center
Recruiting
Kalamazoo
William Beaumont Hospital-Royal Oak
Active, not recruiting
Royal Oak
Munson Medical Center
Suspended
Traverse City
William Beaumont Hospital - Troy
Active, not recruiting
Troy
Minnesota
Fairview Ridges Hospital
Recruiting
Burnsville
Mercy Hospital
Recruiting
Coon Rapids
Essentia Health Cancer Center
Suspended
Duluth
Miller-Dwan Hospital
Recruiting
Duluth
Fairview Southdale Hospital
Recruiting
Edina
Unity Hospital
Recruiting
Fridley
Minnesota Oncology Hematology PA-Maplewood
Recruiting
Maplewood
Saint John's Hospital - Healtheast
Recruiting
Maplewood
Abbott-Northwestern Hospital
Recruiting
Minneapolis
Hennepin County Medical Center
Recruiting
Minneapolis
North Memorial Medical Health Center
Recruiting
Robbinsdale
Mayo Clinic in Rochester
Suspended
Rochester
Park Nicollet Clinic - Saint Louis Park
Recruiting
Saint Louis Park
Regions Hospital
Recruiting
Saint Paul
United Hospital
Recruiting
Saint Paul
Saint Francis Regional Medical Center
Suspended
Shakopee
Lakeview Hospital
Suspended
Stillwater
Ridgeview Medical Center
Recruiting
Waconia
Rice Memorial Hospital
Suspended
Willmar
Minnesota Oncology Hematology PA-Woodbury
Suspended
Woodbury
Missouri
Saint Francis Medical Center
Suspended
Cape Girardeau
University of Missouri - Ellis Fischel
Recruiting
Columbia
University of Kansas Cancer Center - North
Recruiting
Kansas City
University of Kansas Cancer Center - Lee's Summit
Recruiting
Lee's Summit
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Montana
Billings Clinic Cancer Center
Recruiting
Billings
Saint Vincent Healthcare
Suspended
Billings
Benefis Healthcare- Sletten Cancer Institute
Recruiting
Great Falls
Great Falls Clinic
Recruiting
Great Falls
North Carolina
Wake Forest University Health Sciences
Active, not recruiting
Winston-salem
North Dakota
Altru Cancer Center
Recruiting
Grand Forks
Nebraska
CHI Health Saint Francis
Recruiting
Grand Island
CHI Health Good Samaritan
Suspended
Kearney
Nebraska Hematology and Oncology
Suspended
Lincoln
Southeast Nebraska Cancer Center - 68th Street Place
Suspended
Lincoln
Alegent Health Bergan Mercy Medical Center
Recruiting
Omaha
Alegent Health Immanuel Medical Center
Suspended
Omaha
Alegent Health Lakeside Hospital
Suspended
Omaha
Missouri Valley Cancer Consortium
Recruiting
Omaha
Nebraska Cancer Specialists - Omaha
Suspended
Omaha
University of Nebraska Medical Center
Recruiting
Omaha
Midlands Community Hospital
Suspended
Papillion
Regional West Medical Center Cancer Center
Suspended
Scottsbluff
New Hampshire
Dartmouth Hitchcock Medical Center
Active, not recruiting
Lebanon
New Jersey
Rutgers Cancer Institute of New Jersey
Active, not recruiting
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Active, not recruiting
New Brunswick
Overlook Hospital
Active, not recruiting
Summit
New Mexico
University of New Mexico Cancer Center
Recruiting
Albuquerque
Nevada
Comprehensive Cancer Centers of Nevada
Suspended
Las Vegas
GenesisCare USA - Las Vegas
Suspended
Las Vegas
Radiation Oncology Centers of Nevada Central
Recruiting
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Recruiting
Las Vegas
Radiation Oncology Associates
Suspended
Reno
Renown Regional Medical Center
Recruiting
Reno
Saint Mary's Regional Medical Center
Recruiting
Reno
New York
New York-Presbyterian/Brooklyn Methodist Hospital
Active, not recruiting
Brooklyn
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Active, not recruiting
New York
Highland Hospital
Suspended
Rochester
University of Rochester
Recruiting
Rochester
State University of New York Upstate Medical University
Active, not recruiting
Syracuse
Ohio
Case Western Reserve University
Active, not recruiting
Cleveland
Cleveland Clinic Foundation
Suspended
Cleveland
MetroHealth Medical Center
Suspended
Cleveland
Mount Carmel Health Center West
Suspended
Columbus
Ohio State University Comprehensive Cancer Center
Recruiting
Columbus
Riverside Methodist Hospital
Recruiting
Columbus
The Mark H Zangmeister Center
Recruiting
Columbus
Hillcrest Hospital Cancer Center
Recruiting
Mayfield Heights
ProMedica Flower Hospital
Recruiting
Sylvania
Saint Ann's Hospital
Suspended
Westerville
Cleveland Clinic Wooster Family Health and Surgery Center
Active, not recruiting
Wooster
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Recruiting
Tulsa
Oregon
Clackamas Radiation Oncology Center
Suspended
Clackamas
Legacy Mount Hood Medical Center
Active, not recruiting
Gresham
Legacy Good Samaritan Hospital and Medical Center
Recruiting
Portland
Providence Portland Medical Center
Suspended
Portland
Providence Saint Vincent Medical Center
Suspended
Portland
Pennsylvania
Jefferson Abington Hospital
Active, not recruiting
Abington
Lehigh Valley Hospital-Cedar Crest
Suspended
Allentown
Saint Luke's University Hospital-Bethlehem Campus
Recruiting
Bethlehem
Geisinger Medical Center
Active, not recruiting
Danville
Temple University Hospital
Active, not recruiting
Philadelphia
Thomas Jefferson University Hospital
Recruiting
Philadelphia
Allegheny General Hospital
Recruiting
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Active, not recruiting
Pittsburgh
Reading Hospital
Recruiting
West Reading
Geisinger Wyoming Valley/Henry Cancer Center
Active, not recruiting
Wilkes-barre
South Carolina
Prisma Health Cancer Institute - Spartanburg
Active, not recruiting
Boiling Springs
Medical University of South Carolina
Recruiting
Charleston
Greenville Health System Cancer Institute-Andrews
Suspended
Greenville
Prisma Health Cancer Institute - Butternut
Active, not recruiting
Greenville
Prisma Health Cancer Institute - Eastside
Active, not recruiting
Greenville
Prisma Health Cancer Institute - Faris
Active, not recruiting
Greenville
Prisma Health Cancer Institute - Greer
Active, not recruiting
Greer
Prisma Health Cancer Institute - Seneca
Active, not recruiting
Seneca
Spartanburg Medical Center
Active, not recruiting
Spartanburg
South Dakota
Rapid City Regional Hospital
Recruiting
Rapid City
Tennessee
Vanderbilt University/Ingram Cancer Center
Active, not recruiting
Nashville
Texas
Parkland Memorial Hospital
Recruiting
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Active, not recruiting
Dallas
University of Texas Medical Branch
Recruiting
Galveston
UTMB Cancer Center at Victory Lakes
Suspended
League City
Utah
Sandra L Maxwell Cancer Center
Recruiting
Cedar City
Intermountain Medical Center
Recruiting
Murray
Utah Valley Regional Medical Center
Recruiting
Provo
Dixie Medical Center Regional Cancer Center
Recruiting
Saint George
Huntsman Cancer Institute/University of Utah
Active, not recruiting
Salt Lake City
LDS Hospital
Suspended
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Suspended
Salt Lake City
Virginia
Virginia Commonwealth University/Massey Cancer Center
Recruiting
Richmond
VCU Community Memorial Health Center
Recruiting
South Hill
Washington
PeaceHealth Saint Joseph Medical Center
Recruiting
Bellingham
Kadlec Clinic Hematology and Oncology
Suspended
Kennewick
Tri-Cities Cancer Center
Suspended
Kennewick
Skagit Valley Hospital
Suspended
Mount Vernon
Skagit Valley Hospital Regional Cancer Care Center
Suspended
Mount Vernon
Fred Hutchinson Cancer Research Center
Suspended
Seattle
Seattle Cancer Care Alliance
Suspended
Seattle
University of Washington Medical Center - Montlake
Recruiting
Seattle
Virginia Mason Medical Center
Active, not recruiting
Seattle
PeaceHealth Southwest Medical Center
Recruiting
Vancouver
Wisconsin
Northwest Wisconsin Cancer Center
Recruiting
Ashland
Gundersen Lutheran Medical Center
Recruiting
La Crosse
Aurora Saint Luke's Medical Center
Active, not recruiting
Milwaukee
Medical College of Wisconsin
Recruiting
Milwaukee
ProHealth Oconomowoc Memorial Hospital
Suspended
Oconomowoc
ProHealth Waukesha Memorial Hospital
Suspended
Waukesha
UW Cancer Center at ProHealth Care
Suspended
Waukesha
West Virginia
West Virginia University Healthcare
Recruiting
Morgantown
Other Locations
Austria
Medical University Vienna
Recruiting
Vienna
Belgium
Alegemeen Ziekenhuis Middelheim
Recruiting
Antwerpen
Canada
Tom Baker Cancer Centre
Recruiting
Calgary
Cross Cancer Institute
Active, not recruiting
Edmonton
London Regional Cancer Program
Active, not recruiting
London
CHUM - Centre Hospitalier de l'Universite de Montreal
Recruiting
Montreal
CHUM - Hopital Notre-Dame
Suspended
Montreal
Ottawa Hospital and Cancer Center-General Campus
Suspended
Ottawa
Allan Blair Cancer Centre
Suspended
Regina
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Suspended
Toronto
University Health Network-Princess Margaret Hospital
Suspended
Toronto
BCCA-Vancouver Cancer Centre
Suspended
Vancouver
CancerCare Manitoba
Recruiting
Winnipeg
France
Centre Leon Berard
Recruiting
Lyon
Centre Antoine Lacassagne
Recruiting
Nice
Gustave Roussy
Recruiting
Villejuif
Netherlands
Academ Zienkenhuis Bij De University
Recruiting
Amsterdam
University Medical Center Groningen
Recruiting
Groningen
Maastro Clinic-Maastricht Radiation Oncology
Recruiting
Maastricht
Erasmus University Medical Center
Recruiting
Rotterdam
Contact Information
Primary
Kurt Jaeckle, MD
904-953-7102
Time Frame
Start Date: September 2009
Estimated Completion Date: October 2025
Participants
Target number of participants: 360
Treatments
Experimental: Arm A (RT, procarbazine, lomustine, vincristine)
Patients undergo 3D-CRT or IMRT on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride PO on days 8-21, lomustine PO on day 1 and vincristine sulfate IV on days 8 and 29 of courses 3-8. Treatment repeats every 6-7 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B (RT, temozolomide)
Patients undergo RT as in arm I and receive temozolomide PO QD on days 1-5 for 5-7 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide PO QD days 1-5. Treatment with adjuvant temozolomide repeats every 4 weeks for 6-12 courses in the absence of disease progression and unacceptable toxicity.
Authors
Willard G. Andrews, Edward Pan, Hugh D. Moulding, Adam W. Nowlan, Daniel E. Spratt, Robert J. Behrens, Brett J. Theeler, Xiao-Tang Kong, Tanner M. Johanns, Ralph J. Hauke, Matthias Holdhoff, Na Tosha N. Gatson, Bryan A. Faller, Michael Youssef, Samuel T. Chao, Michael Weller, Thomas J. Reid, Andrew B. Lassman, Yuhchyau Chen, Grant R. Seeger, Andrew Y. Kee, Jay W. Carlson, Alton V. Hallum, Tamer R. Abdelrhman, Mehmet S. Copur, Joseph J. Merchant, David D. Tran, Sajeel A. Chowdhary, Michael O. Robinson, Timothy R. Wassenaar, Aruna Padmanabhan, Kathryn A. Arrambide, Warren P. Mason, Timothy D. Moore, Christopher U. Jones, Herbert B. Newton, Kurt A. Jaeckle, John M. Schallenkamp, Nicole A. Shonka, George C. Bobustuc, Grant K. Hunter, Robert Cavaliere, Vinay K. Puduvalli, Keren Sturtz, Abhijit B. Saste, Stephen M. Karlovits, Brian K. Chang, Brian D. Kavanagh, Adam L. Cohen, Carlos A. Alemany, Tulika Ranjan, Priya U. Kumthekar, Kevin P. Becker, Joseph A. Bovi, Joshua Lukenbill, Rebecca A. Harrison, Todd A. Swanson, Michael D. Zurenko, Tolga Tuncer, Puja Nistala, Alison K. Conlin, Edward Melian, Mark G. Malkin, Alfredo D. Voloschin, Ozer Algan, Nicholas DiBella, David L. Grisell, Jethro L. Hu, Orwa Aboud, Benny J. Liem, Terrence P. Cescon, Christine Lu-Emerson, Debra M. Prow, Jeffrey A. Forquer, Martin Colman, Patrick J. Flynn, Collin D. Driscoll, Paul D. Brown, Jian L. Campian, Pierre Giglio, Scott M. Lindhorst, David G. Brachman, Scott G. Turner, Michael R. Girvigian, Uzair B. Chaudhary, Sunil Nagpal, Daniel M. Anderson, David E. Piccioni, James L. Wade, Benjamin T. Marchello, Terence S. Herman, Michelle M. Kim, Bret E. Friday, Aaron C. Spalding, Paul L. Moots, Lynn S. Ashby, John B. Fiveash, Aaron G. Mammoser, Joanna A. Kolodney, Richard L. Deming, Aaron P. Provenzano, George E. Laramore, John L. Villano, Gordon A. Watson, Sameer Rafla-Demetrious, Olivier Rixe, Roger Y. Tsang, Abdel-Ghani Azzouqa, Mussawar Iqbal, Garth Nicholas, Giuseppina L. Masucci, Antonio M. Omuro, Glenn J. Lesser, Craig R. Nichols, Weller Weller, James J. Perry, David A. Clump, Stacy D. D'Andre, Kathleen J. Yost, John A. Ellerton, Li Li, Christopher Dardis, Marshall W. Pitz, Jon Glass, Brian A. Thiessen, Sonikpreet Aulakh, Gamini S. Soori, Michael Michael
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Cancer Trials Group, European Organisation for Research and Treatment Center (EORTC), National Cancer Institute (NCI)
Leads: Alliance for Clinical Trials in Oncology

This content was sourced from clinicaltrials.gov

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