Radiation Therapy With or Without Temozolomide in Treating Patients With Anaplastic Glioma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, TreatmentActive18 and overOtherCDR0000582632
EORTC-26053, CAN-NCIC-CEC1, RTOG-0834, EORTC-22054, EUDRACT-2006-001533-17, SPRI-EORTC-26053, MERCK-EORTC-26053, MRC-BR14, COGNO-EORTC-26053, CEC1, NCT00626990

Trial Description

Summary

RATIONALE: 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. 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.

PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.

Further Study Information

OBJECTIVES:

Primary

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

Secondary

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

OUTLINE: This is a multicenter study. Patients are stratified according to institution, WHO performance status (0 vs > 0), age (≤ 50 vs > 50), presence of 1p LOH only (yes vs no), presence of oligodendroglial elements (yes vs no), and O6-methylguanine-DNA methyltransferase promoter methylation status (methylated vs unmethylated vs indeterminate). Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients undergo radiotherapy* once daily, 5 days a week, for 6.5 weeks (total of 33 fractions).
  • Arm II: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).
  • Arm III: Patients undergo radiotherapy* once daily, 5 days a week for 6.5 weeks (total of 33 fractions). Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses.
  • Arm IV: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy). Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses.

NOTE: *Patients must begin radiotherapy within 8 days after randomization and within 7 weeks after surgery.

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

Patients complete quality-of-life questionnaires, including QLQ-C30 version 3, BCM20, and the Mini Mental Status Exam at baseline, 4 weeks after the completion of radiotherapy, and then every 3 months for 5 years.

Tissue samples are collected at baseline for histology review, 1p/19q analysis, methylation status of the O6-methylguanine-DNA methyltransferase promoter, and isocitrate dehydrogenase mutation analysis.

After completion of study treatment, patients are followed every 3 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:
  • Anaplastic oligodendroglioma
  • Anaplastic oligoastrocytoma
  • Anaplastic astrocytoma
  • Newly diagnosed disease
  • Prior surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
  • Absence of combined 1p/19q loss
  • Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA methyltransferase promoter methylation status assessment, isocitrate dehydrogenase mutation analysis, and central pathology review
  • Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • ANC ≥ 1.5 x 10^9 cells/L
  • Platelet count ≥ 100 x 10^9 cells/L
  • Bilirubin < 1.5 x upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 x ULN
  • AST and ALT < 2.5 x ULN
  • Serum creatinine < 1.5 x ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No known HIV infection or chronic hepatitis B or hepatitis C infection
  • No other serious medical condition that would interfere with follow-up
  • No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
  • No other prior malignancies except for any malignancy which was treated with curative intent more than 5 years prior to registration and adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
  • No prior or concurrent malignancies at other sites except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No psychological, familial, sociological, or geographical condition that would potentially hamper compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy, including carmustine-containing wafers (Gliadel®)
  • No prior radiotherapy to the brain
  • No concurrent growth factors unless vital for the patient
  • No other concurrent investigational treatment
  • No other concurrent anticancer agents

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

  • NCIC-Clinical Trials Group
  • Radiation Therapy Oncology Group
  • Medical Research Council's Working Party on Leukemia in Adults and Children
  • Cooperative Trials Group for Neuro-Oncology
Wolfgang Wick, Study Chair
Warren P. Mason, Study Chair
Michael A. Vogelbaum, Study Chair
S. Erridge, Study Chair
Anna Nowak, Study Chair

Trial Sites

U.S.A.

Alabama
Birmingham

Kirklin Clinic at Acton Road

John Fiveash
Ph: 205-934-0309

UAB Comprehensive Cancer Center

John Fiveash
Ph: 205-934-0309

Arizona
Phoenix

St. Joseph's Hospital and Medical Center

David G. Brachman
Ph: 877-602-4111

Scottsdale

Arizona Oncology Services Foundation

David G. Brachman
Ph: 877-602-4111

California
Los Angeles

Kaiser Permanente Medical Center - Los Angeles

Michael R Girvigian
Ph: 626-564-3455

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Jeremy D Rudnick
Ph: 310-423-8965

Florida
Gainesville

UF Health Cancer Center

Robert J Amdur
Ph: 352-273-8675
Email: trials@cancer.ufl.edu

Jacksonville

Mayo Clinic - Jacksonville

Kurt A. Jaeckle
Ph: 507-538-7623

Georgia
Atlanta

Piedmont Hospital

Adam W Nowlan
Ph: 404-425-7943
Email: ORS@piedmont.org

Winship Cancer Institute of Emory University

Hui-Kuo G Shu
Ph: 404-778-1868

Savannah

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Aaron W Pederson
Ph: 912-350-8568

Illinois
Chicago

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Priya U Kumthekar
Ph: 312-695-1301
Email: cancer@northwestern.edu

Maywood

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Edward Melian
Ph: 708-226-4357

Pekin

Cancer Treatment Center at Pekin Hospital

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Peoria

Illinois CancerCare - Peoria

Nguyet A Le-Lindqwister
Ph: 800-793-2262

OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC

Nguyet A Le-Lindqwister
Ph: 800-793-2262

OSF St. Francis Medical Center

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Warrenville

Central Dupage Cancer Center

Sean A Grimm
Ph: 630-352-5300

Indiana
Fort Wayne

Parkview Regional Cancer Center at Parkview Health

Brian K Chang
Ph: 260-373-8888
Email: parkviewresearch@parkview.com

Radiation Oncology Associates Southwest

Brian K Chang
Ph: 260-373-8888
Email: parkviewresearch@parkview.com

Iowa
Ames

McFarland Clinic, PC

Joseph James Merchant
Ph: 515-239-2621

Sioux City

Siouxland Hematology-Oncology Associates, LLP

Donald Bruce Wender
Ph: 712-252-0088

Kansas
Wichita

Via Christi Cancer Center at Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Kentucky
Louisville

Louisville Oncology at Norton Cancer Institute - Louisville

Aaron C Spalding
Ph: 502-629-2500

Norton Suburban Hospital

Aaron C Spalding
Ph: 502-629-2500

Michigan
Ann Arbor

Saint Joseph Mercy Cancer Center

Samir Narayan
Ph: 734-712-4673

Detroit

Josephine Ford Cancer Center at Henry Ford Hospital

Eleanor M. Walker
Ph: 313-916-1784

Kalamazoo

West Michigan Cancer Center

Raymond Sterling Lord
Ph: 269-373-7458

Minnesota
Rochester

Mayo Clinic Cancer Center

Kurt A. Jaeckle
Ph: 507-538-7623

Missouri
Saint Louis

Barnes-Jewish West County Hospital

Clifford G Robinson
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Clifford G Robinson
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Nebraska
Omaha

Fred and Pamela Buffett Cancer Center

Nicole A Shonka
Ph: 402-559-6941
Email: unmcrsa@unmc.edu

Methodist Estabrook Cancer Center

Tien-Shew W Huang
Ph: 402-354-5144

New Hampshire
Lebanon

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Alan C. Hartford
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New York
Rochester

Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester

Yuhchyau Chen
Ph: 585-275-5830

James P. Wilmot Cancer Center at University of Rochester Medical Center

Yuhchyau Chen
Ph: 585-275-5830

Syracuse

SUNY Upstate Medical University Hospital

Anna Shapiro
Ph: 315-464-5476

North Dakota
Grand Forks

Altru Cancer Center at Altru Hospital

Grant R Seeger
Ph: 701-780-6520

Ohio
Akron

Summa Center for Cancer Care at Akron City Hospital

Jennifer E Payne
Ph: 330-375-6101

Barberton

Barberton Citizens Hospital

Jennifer E Payne
Ph: 330-375-6101

Beachwood

UHHS Chagrin Highlands Medical Center

Samuel T Chao
Ph: 866-223-8100

Cleveland

Case Comprehensive Cancer Center

Samuel T Chao
Ph: 866-223-8100

Cleveland Clinic Taussig Cancer Center

Samuel T Chao
Ph: 866-223-8100

Medina

Summa Health Center at Lake Medina

Jennifer E Payne
Ph: 330-375-6101

Mentor

Lake/University Ireland Cancer Center

Samuel T Chao
Ph: 866-223-8100

Middleburg Heights

Southwest General Health Center

Samuel T Chao
Ph: 866-223-8100

Westlake

UHHS Westlake Medical Center

Samuel T Chao
Ph: 866-223-8100

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

Terence S. Herman
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Pennsylvania
Abington

Rosenfeld Cancer Center at Abington Memorial Hospital

Wayne H Pinover
Ph: 215-481-2402

Bethlehem

St. Luke's Cancer Network at St. Luke's Hospital

Nimisha Deb
Ph: 610-954-3582
Email: infolink@slhn.org

Hershey

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

Henry Wagner
Ph: 717-531-3779
Email: CTO@hmc.psu.edu

Philadelphia

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Wenyin Shi
Ph: 215-955-6084

West Reading

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Albert Yuen
Ph: 610-988-9323

South Carolina
Charleston

Hollings Cancer Center at Medical University of South Carolina

Scott M Lindhorst
Ph: 843-792-9321

Greenville

Cancer Centers of the Carolinas - Faris Road

David L Grisell
Ph: 864-241-6251

CCOP - Greenville

David L Grisell
Ph: 864-241-6251

Greer

Cancer Centers of the Carolinas - Greer Radiation Oncology

David L Grisell
Ph: 864-241-6251

Seneca

Cancer Centers of the Carolinas - Seneca

David L Grisell
Ph: 864-241-6251

South Dakota
Rapid City

Rapid City Regional Hospital

Michael J Swartz
Ph: 605-716-3982
Email: research@rcrh.org

Texas
Austin

University Medical Center Brackenridge

Mateo Ziu
Ph: 512-324-7991

Dallas

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Edward Pan
Ph: 214-648-7097

Galveston

University of Texas Medical Branch

Martin Colman
Ph: 409-772-1950
Email: clinical.research@utmb.edu

League City

UTMB Cancer Center at Victory Lakes

Martin Colman
Ph: 409-772-1950
Email: clinical.research@utmb.edu

Utah
Murray

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

R. Jeffrey Lee
Ph: 801-507-3950

Ogden

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

R. Jeffrey Lee
Ph: 801-507-3950

Provo

Utah Valley Regional Medical Center - Provo

R. Jeffrey Lee
Ph: 801-507-3950

Saint George

Dixie Regional Medical Center - East Campus

R. Jeffrey Lee
Ph: 801-507-3950

Salt Lake City

Huntsman Cancer Institute at University of Utah

Dennis C. Shrieve
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

LDS Hospital

R. Jeffrey Lee
Ph: 801-507-3950

Virginia
Richmond

Virginia Commonwealth University Massey Cancer Center

Mark G Malkin
Ph: 804-628-1939

Washington
Mount Vernon

Skagit Valley Hospital Cancer Care Center

George E. Laramore
Ph: 206-616-8289

Seattle

University Cancer Center at University of Washington Medical Center

George E. Laramore
Ph: 206-616-8289

Wisconsin
Madison

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Steven P Howard
Ph: 877-405-6866

Milwaukee

Froedtert Hospital and Medical College of Wisconsin

Christopher J. Schultz
Ph: 414-805-4380

Waukesha

Waukesha Memorial Hospital Regional Cancer Center

Wingate F. Clapper
Ph: 262-928-7632

Canada

Alberta
Calgary

Tom Baker Cancer Centre - Calgary

Robert A Nordal
Ph: 403-521-3433

Manitoba
Winnipeg

CancerCare Manitoba

Marshall W Pitz
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

Ontario
Hamilton

Margaret and Charles Juravinski Cancer Centre

Jeffrey N Greenspoon
Ph: 905-387-9495

London

London Regional Cancer Program at London Health Sciences Centre

David R MacDonald
Ph: 519-685-8600

Toronto

Princess Margaret Hospital

Warren P Mason
Ph: 416-946-4501
Email: clinical.trials@uhn.on.ca

Quebec
Montreal

Hopital Notre-Dame du CHUM

Giuseppina L Masucci
Ph: 514-890-8000ext23611
Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

Saskatchewan
Regina

Allan Blair Cancer Centre at Pasqua Hospital

Muhammad Salim
Ph: 306-766-2213

Saskatoon

Saskatoon Cancer Centre at the University of Saskatchewan

Sunil K Yadav
Ph: 306-655-2914

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00626990
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.