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Radiation Therapy with or without Temozolomide in Treating Patients with Anaplastic Glioma

Trial Status: Closed to Accrual and Intervention

This phase III trial studies temozolomide given during and / or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and / or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

Inclusion Criteria

  • AT THE TIME OF REGISTRATION: Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis
  • AT THE TIME OF REGISTRATION: Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review
  • AT THE TIME OF REGISTRATION: Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
  • AT THE TIME OF REGISTRATION: World Health Organization (WHO) performance status 0-2
  • AT THE TIME OF REGISTRATION: Age >= 18 years
  • AT THE TIME OF REGISTRATION: All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding
  • AT THE TIME OF REGISTRATION: Absence of known human immunodeficiency virus (HIV) infection, chronic hepatitis B or hepatitis C infection
  • AT THE TIME OF REGISTRATION: Absence of any other serious medical condition that can interfere with follow-up
  • AT THE TIME OF REGISTRATION: Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
  • AT THE TIME OF REGISTRATION: No previous other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to registration, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix
  • AT THE TIME OF REGISTRATION: Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • AT THE TIME OF REGISTRATION: No prior chemotherapy (including no treatment with carmustine [BCNU] containing wafers [Gliadel])
  • AT THE TIME OF REGISTRATION: No prior radiotherapy to the brain
  • AT THE TIME OF REGISTRATION: Before patient registration, written informed consent must be obtained, according to International Conference on Harmonisation/Good Clinical Practice (ICH/GCP), and national/local regulations
  • RANDOMIZATION STEP: The combination of: * Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis AND * Absence of combined 1p/19q loss Both of which must have been determined by either local testing or central review
  • RANDOMIZATION STEP: Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review
  • RANDOMIZATION STEP: WHO performance status 0-2
  • RANDOMIZATION STEP: Age >= 18 years
  • RANDOMIZATION STEP: Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
  • RANDOMIZATION STEP: Start of radiotherapy within 8 days from randomization
  • RANDOMIZATION STEP: Start of radiotherapy within 7 weeks (49 days) from surgery (extra 2 days could be allowed)
  • RANDOMIZATION STEP: Patients must be on a stable or decreasing dose of steroids for at least two weeks
  • RANDOMIZATION STEP: No prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel)
  • RANDOMIZATION STEP: No prior radiotherapy to the brain
  • RANDOMIZATION STEP: No concomitant treatment with other anti-cancer agents or with any other experimental agent
  • RANDOMIZATION STEP: Neutrophils greater or equal to 1.5*10^9 cells/l (to be performed within 28 days prior to randomization)
  • RANDOMIZATION STEP: Platelets greater or equal to 100*10^9 cells/l (to be performed within 28 days prior to randomization)
  • RANDOMIZATION STEP: Bilirubin < 1.5 times upper limit of laboratory normal (to be performed within 28 days prior to randomization)
  • RANDOMIZATION STEP: Alkaline phosphatase, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 2.5 times upper limit of laboratory normal (to be performed within 28 days prior to randomization)
  • RANDOMIZATION STEP: Serum creatinine lower than 1.5 times upper limit of laboratory normal (to be performed within 28 days prior to randomization)
  • RANDOMIZATION STEP: All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding
  • RANDOMIZATION STEP: Absence of known HIV infection, chronic hepatitis B or hepatitis C infection
  • RANDOMIZATION STEP: Absence of any other serious medical condition that could interfere with follow-up
  • RANDOMIZATION STEP: Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
  • RANDOMIZATION STEP: Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • RANDOMIZATION STEP: Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
  • RANDOMIZATION STEP: Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable

Alabama

Birmingham
The Kirklin Clinic at Acton Road
Status: COMPLETED
Contact: John B. Fiveash
Phone: 205-934-0309
University of Alabama at Birmingham Cancer Center
Status: COMPLETED
Contact: John B. Fiveash
Phone: 205-934-0309

Arizona

Phoenix
Saint Joseph's Hospital and Medical Center
Status: COMPLETED
Contact: David G. Brachman
Phone: 877-602-4111
Scottsdale
Arizona Oncology Services Foundation
Status: COMPLETED
Contact: David G. Brachman
Phone: 877-602-4111

California

Los Angeles
Cedars Sinai Medical Center
Status: COMPLETED
Contact: Jeremy David Rudnick
Phone: 310-423-8965
Kaiser Permanente Los Angeles Medical Center
Status: COMPLETED
Contact: Michael Raymond Girvigian
Phone: 626-564-3455
San Francisco
UCSF Medical Center-Mount Zion
Status: COMPLETED
Contact: Patricia K. Sneed
Phone: 877-827-3222

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: COMPLETED
Contact: Robert Jess Amdur
Phone: 352-273-8675
Jacksonville
Mayo Clinic in Florida
Status: COMPLETED
Contact: Kurt A. Jaeckle
Phone: 507-538-7623
Orlando
AdventHealth Orlando
Status: CLOSED_TO_ACCRUAL
Contact: Robert James Sollaccio
Phone: 407-303-5623

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: COMPLETED
Contact: Hui-Kuo George Shu
Phone: 404-778-1868
Piedmont Hospital
Status: COMPLETED
Contact: Adam Wayne Nowlan
Phone: 404-425-7943
Fayetteville
Piedmont Fayette Hospital
Status: COMPLETED
Contact: Adam Wayne Nowlan
Phone: 404-425-7943
Savannah
Memorial Health University Medical Center
Status: COMPLETED
Contact: Aaron Watson Pederson
Phone: 912-350-8568

Illinois

Chicago
Northwestern University
Status: COMPLETED
Contact: Priya Uday Kumthekar
Phone: 312-695-1301
University of Chicago Comprehensive Cancer Center
Status: COMPLETED
Contact: Martin Kelly Nicholas
Phone: 312-355-3046
La Grange
AMITA Health Adventist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey M. Feinstein
Phone: 708-245-8155
Maywood
Loyola University Medical Center
Status: COMPLETED
Contact: Edward Melian
Phone: 708-226-4357
Normal
Carle Cancer Institute Normal
Status: COMPLETED
Contact: Nguyet Anh Le-Lindqwister
Phone: 800-793-2262
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: COMPLETED
Contact: James Lloyd Wade
Phone: 217-876-4740
Peoria
Illinois CancerCare-Peoria
Status: COMPLETED
Contact: James Lloyd Wade
Phone: 217-876-4740
OSF Saint Francis Medical Center
Status: COMPLETED
Contact: James Lloyd Wade
Phone: 217-876-4740
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: COMPLETED
Contact: James Lloyd Wade
Phone: 217-876-4740
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: COMPLETED
Contact: Sean A. Grimm
Phone: 630-352-5300

Indiana

Fort Wayne
Parkview Hospital Randallia
Status: COMPLETED
Contact: Brian K. Chang
Phone: 260-373-8888
Radiation Oncology Associates PC
Status: COMPLETED
Contact: Brian K. Chang
Phone: 260-373-8888

Iowa

Ames
McFarland Clinic PC - Ames
Status: COMPLETED
Contact: Joseph James Merchant
Phone: 515-239-2621
Sioux City
Siouxland Regional Cancer Center
Status: COMPLETED
Contact: Donald B. Wender
Phone: 712-252-0088

Kansas

Kansas City
University of Kansas Cancer Center
Status: COMPLETED
Contact: Parvesh Kumar
Phone: 913-945-7552
Wichita
Ascension Via Christi Hospitals Wichita
Status: COMPLETED
Contact: Shaker R. Dakhil
Phone: 316-262-4467
Wesley Medical Center
Status: COMPLETED
Contact: Shaker R. Dakhil
Phone: 316-262-4467

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: William H. St. Clair
Phone: 859-257-3379
Louisville
Norton Hospital Pavilion and Medical Campus
Status: COMPLETED
Contact: Aaron C. Spalding
Phone: 502-629-2500
Norton Suburban Hospital and Medical Campus
Status: COMPLETED
Contact: Aaron C. Spalding
Phone: 502-629-2500

Maine

Scarborough
Maine Medical Center- Scarborough Campus
Status: COMPLETED
Contact: Ian Jared Bristol
Phone: 207-396-8090

Massachusetts

Boston
Boston Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Minh Tam Truong
Phone: 617-638-8265
Brigham and Women's Hospital
Status: COMPLETED
Contact: Helen A. Shih
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center
Status: COMPLETED
Contact: Helen A. Shih
Phone: 877-726-5130

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: COMPLETED
Contact: Samir Narayan
Phone: 734-712-4673
Detroit
Henry Ford Hospital
Status: COMPLETED
Contact: Eleanor M. Walker
Phone: 313-916-1784
Kalamazoo
West Michigan Cancer Center
Status: COMPLETED
Contact: Sunil Nagpal
Phone: 269-373-7458

Minnesota

Rochester
Mayo Clinic in Rochester
Status: COMPLETED
Contact: Kurt A. Jaeckle
Phone: 507-538-7623

Missouri

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: COMPLETED
Contact: Clifford G. Robinson
Phone: 800-600-3606
Saint Louis
Mercy Hospital Saint Louis
Status: COMPLETED
Contact: Bethany Graham Sleckman
Phone: 913-948-5588
Siteman Cancer Center-South County
Status: COMPLETED
Contact: Clifford G. Robinson
Phone: 800-600-3606
Washington University School of Medicine
Status: COMPLETED
Contact: Clifford G. Robinson
Phone: 800-600-3606

Nebraska

Omaha
Nebraska Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Tien-Shew William Huang
Phone: 402-354-5144
University of Nebraska Medical Center
Status: COMPLETED
Contact: Nicole Annette Shonka
Phone: 402-559-6941

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: COMPLETED
Contact: Alan Charles Hartford
Phone: 800-639-6918

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: COMPLETED
Contact: Fa-Chyi Lee
Phone: 505-272-6972

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: COMPLETED
Contact: Andrew B. Lassman
Phone: 212-305-8615
Rochester
Highland Hospital
Status: COMPLETED
Contact: Yuhchyau Chen
Phone: 585-275-5830
University of Rochester
Status: COMPLETED
Contact: Yuhchyau Chen
Phone: 585-275-5830
Syracuse
State University of New York Upstate Medical University
Status: CLOSED_TO_ACCRUAL
Contact: Anna Shapiro
Phone: 315-464-5476

North Carolina

Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: COMPLETED
Contact: Stuart H. Burri
Phone: 704-355-2884

North Dakota

Grand Forks
Altru Cancer Center
Status: COMPLETED
Contact: Grant Richard Seeger
Phone: 701-780-6520

Ohio

Akron
Summa Health System - Akron Campus
Status: COMPLETED
Contact: Jennifer Eileen Payne
Phone: 330-375-6101
Barberton
Summa Health System - Barberton Campus
Status: COMPLETED
Contact: Jennifer Eileen Payne
Phone: 330-375-6101
Beachwood
UHHS-Chagrin Highlands Medical Center
Status: COMPLETED
Contact: Samuel Tay Chao
Phone: 866-223-8100
Cleveland
Case Western Reserve University
Status: COMPLETED
Contact: Samuel Tay Chao
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: COMPLETED
Contact: Samuel Tay Chao
Phone: 866-223-8100
MetroHealth Medical Center
Status: COMPLETED
Contact: Bruce J. Averbook
Phone: 216-778-8526
Columbus
Ohio State University Comprehensive Cancer Center
Status: COMPLETED
Contact: Arnab Chakravarti
Phone: 800-293-5066
Medina
Summa Health Medina Medical Center
Status: COMPLETED
Contact: Jennifer Eileen Payne
Phone: 330-375-6101
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: COMPLETED
Contact: Samuel Tay Chao
Phone: 866-223-8100
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: COMPLETED
Contact: Samuel Tay Chao
Phone: 866-223-8100
Salem
UH Seidman Cancer Center at Salem Regional Medical Center
Status: COMPLETED
Contact: Charles Andrew Kunos
Phone: 800-641-2422
Westlake
UHHS-Westlake Medical Center
Status: COMPLETED
Contact: Samuel Tay Chao
Phone: 866-223-8100
Wooster
Cancer Treatment Center
Status: COMPLETED
Contact: Charles Andrew Kunos
Phone: 800-641-2422

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: COMPLETED
Contact: Terence S. Herman
Phone: 405-271-4272

Pennsylvania

Abington
Jefferson Abington Hospital
Status: COMPLETED
Contact: Wayne H. Pinover
Phone: 215-481-2402
Allentown
Lehigh Valley Hospital-Cedar Crest
Status: CLOSED_TO_ACCRUAL
Contact: Eliot L. Friedman
Phone: 610-402-2273
Beaver
UPMC-Heritage Valley Health System Beaver
Status: COMPLETED
Contact: Frank Scott Lieberman
Phone: 412-647-8073
Bethlehem
Saint Luke's University Hospital-Bethlehem Campus
Status: COMPLETED
Contact: Nimisha Deb
Phone: 610-954-3582
Hershey
Penn State Milton S Hershey Medical Center
Status: COMPLETED
Contact: Henry Wagner
Phone: 717-531-3779
Philadelphia
Thomas Jefferson University Hospital
Status: COMPLETED
Contact: Wenyin Shi
Phone: 215-955-6084
West Reading
Reading Hospital
Status: COMPLETED
Contact: Michael L. Haas
Phone: 610-988-9323

South Carolina

Charleston
Medical University of South Carolina
Status: COMPLETED
Contact: Scott Michael Lindhorst
Phone: 843-792-9321
Greenville
Prisma Health Cancer Institute - Eastside
Status: COMPLETED
Contact: David Lawrence Grisell
Phone: 864-241-6251
Prisma Health Cancer Institute - Faris
Status: COMPLETED
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greer
Prisma Health Cancer Institute - Greer
Status: COMPLETED
Contact: David Lawrence Grisell
Phone: 864-241-6251
Seneca
Prisma Health Cancer Institute - Seneca
Status: COMPLETED
Contact: David Lawrence Grisell
Phone: 864-241-6251
Spartanburg
Spartanburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Patricia C. Griffin
Phone: 800-486-5941

South Dakota

Rapid City
Rapid City Regional Hospital
Status: COMPLETED
Contact: Michael J. Swartz
Phone: 605-716-3982

Texas

Austin
Dell Seton Medical Center at The University of Texas
Status: COMPLETED
Contact: Mateo Ziu
Phone: 512-324-7991
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: COMPLETED
Contact: Edward Pan
Phone: 214-648-7097
Galveston
University of Texas Medical Branch
Status: COMPLETED
Contact: Martin Colman
Phone: 409-772-1950
Houston
Houston Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Pamela Z. New
Phone: 713-790-2700
M D Anderson Cancer Center
Status: COMPLETED
Contact: John Frederick de Groot
Phone: 713-792-3245
League City
UTMB Cancer Center at Victory Lakes
Status: COMPLETED
Contact: Martin Colman
Phone: 409-772-1950

Utah

Murray
Intermountain Medical Center
Status: COMPLETED
Contact: R. Jeffrey Lee
Phone: 801-507-3950
Ogden
McKay-Dee Hospital Center
Status: COMPLETED
Contact: R. Jeffrey Lee
Phone: 801-507-3950
Provo
Utah Valley Regional Medical Center
Status: COMPLETED
Contact: R. Jeffrey Lee
Phone: 801-507-3950
Saint George
Dixie Medical Center Regional Cancer Center
Status: COMPLETED
Contact: R. Jeffrey Lee
Phone: 801-507-3950
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Dennis Charles Shrieve
Phone: 801-581-4477
LDS Hospital
Status: COMPLETED
Contact: R. Jeffrey Lee
Phone: 801-507-3950

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: COMPLETED
Contact: Mark G. Malkin
Phone: 804-628-1939

Washington

Everett
Providence Regional Cancer Partnership
Status: COMPLETED
Contact: John A. Keech
Phone: 907-458-5380
Kennewick
Tri-Cities Cancer Center
Status: COMPLETED
Contact: George E. Laramore
Phone: 206-616-8289
Mount Vernon
Skagit Valley Hospital
Status: COMPLETED
Contact: George E. Laramore
Phone: 206-616-8289
Seattle
Swedish Medical Center-First Hill
Status: COMPLETED
Contact: Vivek Krishan Mehta
Phone: 206-386-2323
University of Washington Medical Center - Montlake
Status: COMPLETED
Contact: George E. Laramore
Phone: 206-616-8289
Virginia Mason Medical Center
Status: WITHDRAWN
Contact: Huong Thanh Pham
Phone: 206-342-6954
Tacoma
Northwest NCI Community Oncology Research Program
Status: CLOSED_TO_ACCRUAL
Contact: John A. Keech
Phone: 907-458-5380

West Virginia

Morgantown
West Virginia University Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Manish Monga
Phone: 304-293-2745

Wisconsin

Green Bay
Green Bay Oncology Limited at Saint Mary's Hospital
Status: COMPLETED
Contact: James L. Leenstra
Phone: 507-645-2655
Green Bay Oncology at Saint Vincent Hospital
Status: COMPLETED
Contact: James L. Leenstra
Phone: 507-645-2655
Saint Vincent Hospital Cancer Center Green Bay
Status: COMPLETED
Contact: James L. Leenstra
Phone: 507-645-2655
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: COMPLETED
Contact: James L. Leenstra
Phone: 507-645-2655
La Crosse
Gundersen Lutheran Medical Center
Status: COMPLETED
Contact: Collin D. Driscoll
Phone: 608-775-2385
Madison
University of Wisconsin Hospital and Clinics
Status: COMPLETED
Contact: Steven Paul Howard
Phone: 877-405-6866
Milwaukee
Medical College of Wisconsin
Status: COMPLETED
Contact: Christopher J. Schultz
Phone: 414-805-4380
Waukesha
ProHealth Waukesha Memorial Hospital
Status: COMPLETED
Contact: Wingate F. Clapper
Phone: 262-928-7632

Alberta

Calgary
Tom Baker Cancer Centre
Status: COMPLETED
Contact: Robert Allan Nordal
Phone: 403-521-3433
Edmonton
Cross Cancer Institute
Status: COMPLETED
Contact: Wilson H. Roa
Phone: 780-432-8500

Manitoba

Winnipeg
CancerCare Manitoba
Status: COMPLETED
Contact: Marshall W. Pitz
Phone: 866-561-1026

Ontario

Hamilton
Juravinski Cancer Centre at Hamilton Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Noah Greenspoon
Phone: 905-387-9495
London
London Regional Cancer Program
Status: COMPLETED
Contact: David Roy Macdonald
Phone: 519-685-8600
Toronto
University Health Network-Princess Margaret Hospital
Status: COMPLETED
Contact: Warren P. Mason
Phone: 416-946-4501

Quebec

Montreal
CHUM - Hopital Notre-Dame
Status: COMPLETED
Contact: Giuseppina Laura Masucci
Phone: 514-890-8000extn23611

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: COMPLETED
Contact: Muhammad Salim
Phone: 306-766-2213
Saskatoon
Saskatoon Cancer Centre
Status: COMPLETED
Contact: Sunil K. Yadav
Phone: 306-655-2914

PRIMARY OBJECTIVES:

l. To assess whether concurrent radiotherapy with daily temozolomide improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma.

II. To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in patients with non-1p/19q deleted anaplastic glioma.

SECONDARY OBJECTIVES:

I. To assess whether concurrent and adjuvant temozolomide prolongs progression-free survival and neurological deterioration-free survival in patients with non-1p/19q deleted anaplastic glioma.

II. To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition.

III. To assess the impact of concurrent and adjuvant temozolomide on the quality of life in patients with non-1p/19q deleted anaplastic glioma.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients undergo radiation therapy once daily (QD) 5 days a week, for 6.5 weeks (total of 33 fractions).

ARM II: Patients undergo radiation therapy as in Arm I and receive temozolomide orally (PO) QD for 6.5 weeks.

ARM III: Patients undergo radiation therapy as in Arm I. Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant temozolomide PO QD on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 cycles.

ARM IV: Patients undergo radiation therapy and temozolomide PO as in Arm I. Beginning 4 weeks after completion of radiation therapy, patients receive adjuvant temozolomide as in Arm III.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Michael A. Vogelbaum

  • Primary ID RTOG-0834
  • Secondary IDs NCI-2011-02070, CAN-NCIC-CEC1, CDR0000582632, COGNO-EORTC-26053, EORTC-22054, EORTC-26053, EUDRACT-2006-001533-17, MERCK-EORTC-26053, MRC-BR14
  • Clinicaltrials.gov ID NCT00626990