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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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 WickStudy Chair

Warren P. MasonStudy Chair

Michael A. VogelbaumStudy Chair

S. ErridgeStudy Chair

Anna NowakStudy 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
  Scottsdale
 Arizona Oncology Services Foundation
 David G. Brachman Ph: 800-360-6371
California
  Los Angeles
 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
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Robert J Sollaccio Ph: 407-303-5623
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
  Fayetteville
 Piedmont Fayette Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: ORS@piedmont.org
  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
  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
  Email: cancer@northwestern.edu
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
 Wesley 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
Maine
  Scarborough
 Maine Medical Center- Scarborough Campus
 Ian J Bristol Ph: 207-396-8090
  Email: wrighd@mmc.org
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
 Clifford G Robinson Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Nicole A Shonka Ph: 800-999-5465
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 Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Fa-Chyi Lee Ph: 505-272-6972
New York
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Andrew B Lassman Ph: 212-305-8615
  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
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
  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
 Charles A Kunos Ph: 330-375-6101
  Middleburg Heights
 Southwest General Health Center
 Samuel T Chao Ph: 866-223-8100
  Orange Village
 UHHS Chagrin Highlands Medical Center
 Samuel T Chao Ph: 866-223-8100
  Westlake
 UHHS Westlake Medical Center
 Samuel T Chao Ph: 866-223-8100
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 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
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Eliot Lawrence Friedman Ph: 610-402-2273
  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
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Patricia C Griffin Ph: 800-486-5941
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
 Brian D Vaillant Ph: 512-324-7991
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Edward Pan Ph: 214-648-7097
  Email: canceranswers@moffitt.org
  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
  Tacoma
 CCOP - Northwest
 John A Keech Ph: 253-887-9333
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 James L Leenstra Ph: 920-433-8889
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 James L Leenstra Ph: 920-433-8889
 St. Mary's Hospital Medical Center - Green Bay
 James L Leenstra Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 James L Leenstra Ph: 920-433-8889
  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
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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00626990
ClinicalTrials.gov processed this data on January 15, 2014

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.

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