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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, Treatment18 and overRTOG 0834
NCI-2011-02070, CAN-NCIC-CEC1, CDR0000582632, COGNO-EORTC-26053, EORTC-22054, EORTC-26053, EUDRACT-2006-001533-17, MERCK-EORTC-26053, MRC-BR14, SPRI-EORTC-26053, CEC1, NCT00626990

Trial Description

Summary

This randomized 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. 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. 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.

Further Study Information

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 improves survival as compared to no adjuvant temozolomide 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 of patients with non-1p/19q deleted anaplastic glioma.

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

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

ARM II: Patients undergo radiotherapy as in Arm I and receive temozolomide orally (PO) QD for 6.5 weeks (total of 33 fractions of radiotherapy).

ARM III: Patients undergo radiotherapy 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 courses.

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

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.

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

Eligibility Criteria

Inclusion Criteria:

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 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 surgery for a low grade tumor is allowed, provided histological confirmation of anaplastic tumor is present at the time of progression

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

Histologically confirmed diagnosis of 1 of the following:

Anaplastic oligodendroglioma

Anaplastic oligoastrocytoma

Anaplastic astrocytoma

Absolute neutrophil count (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)

Absence of combined 1p/19q loss

Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization

World Health Organization (WHO) performance status 0-2

Alkaline phosphatase < 2.5 x ULN

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN

Serum creatinine < 1.5 x ULN

Not pregnant or nursing

Fertile patients must use effective contraception

No known human immunodeficiency virus (HIV) infection or chronic hepatitis B or hepatitis C infection

No prior chemotherapy, including carmustine-containing wafers (Gliadel®)

Newly diagnosed disease

Tumor material available for central 1p/19q assessment, central O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase promoter methylation status assessment, isocitrate dehydrogenase mutation analysis, and central pathology review

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • National Cancer Institute
  • NCIC-Clinical Trials Group
  • Medical Research Council Clinical Trials Unit
  • Radiation Therapy Oncology Group
Michael A. Vogelbaum, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

The Kirklin Clinic at Acton Road

John B. Fiveash
Ph: 205-934-0309

John B. Fiveash
Principal Investigator

University of Alabama at Birmingham Cancer Center

John B. Fiveash
Ph: 205-934-0309

John B. Fiveash
Principal Investigator

Arizona
Phoenix

Saint Joseph's Hospital and Medical Center

David G. Brachman
Ph: 877-602-4111

David G. Brachman
Principal Investigator

Scottsdale

Arizona Oncology Services Foundation

David G. Brachman
Ph: 877-602-4111

David G. Brachman
Principal Investigator

California
Los Angeles

Cedars-Sinai Medical Center

Jeremy David Rudnick
Ph: 310-423-8965

Jeremy David Rudnick
Principal Investigator

Florida
Gainesville

University of Florida

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

Robert Jess Amdur
Principal Investigator

Jacksonville

Mayo Clinic in Florida

Kurt A. Jaeckle
Ph: 507-538-7623

Kurt A. Jaeckle
Principal Investigator

Georgia
Atlanta

Piedmont Hospital

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

Adam Wayne Nowlan
Principal Investigator

Illinois
Chicago

Northwestern University

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

Priya Uday Kumthekar
Principal Investigator

Maywood

Loyola University Medical Center

Edward Melian
Ph: 708-226-4357

Edward Melian
Principal Investigator

Pekin

Pekin Cancer Treatment Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Peoria

Illinois CancerCare-Peoria

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

OSF Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

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

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Warrenville

Cadence Cancer Center in Warrenville

Sean A. Grimm
Ph: 630-352-5300

Sean A. Grimm
Principal Investigator

Indiana
Fort Wayne

Parkview Hospital Randallia

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

Brian K. Chang
Principal Investigator

Radiation Oncology Associates PC

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

Brian K. Chang
Principal Investigator

Iowa
Ames

McFarland Clinic PC-William R Bliss Cancer Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088

Donald B. Wender
Principal Investigator

Kansas
Kansas City

University of Kansas Cancer Center

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Wichita

Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wesley Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Kentucky
Louisville

Norton Hospital Pavilion and Medical Campus

Aaron C. Spalding
Ph: 502-629-2500

Aaron C. Spalding
Principal Investigator

Norton Suburban Hospital and Medical Campus

Aaron C. Spalding
Ph: 502-629-2500

Aaron C. Spalding
Principal Investigator

Maine
Scarborough

Maine Medical Center- Scarborough Campus

Ian Jared Bristol
Ph: 207-396-8090
Email: wrighd@mmc.org

Ian Jared Bristol
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Detroit

Henry Ford Hospital

Eleanor M. Walker
Ph: 313-916-1784

Eleanor M. Walker
Principal Investigator

Kalamazoo

West Michigan Cancer Center

Raymond Sterling Lord
Ph: 269-373-7458

Raymond Sterling Lord
Principal Investigator

Minnesota
Rochester

Mayo Clinic

Kurt A. Jaeckle
Ph: 507-538-7623

Kurt A. Jaeckle
Principal Investigator

Missouri
Saint Louis

Barnes-Jewish West County Hospital

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

Clifford G Robinson
Principal Investigator

Siteman Cancer Center-South County

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

Clifford G Robinson
Principal Investigator

Washington University School of Medicine

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

Clifford G Robinson
Principal Investigator

Nebraska
Omaha

Nebraska Methodist Hospital

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

Tien-Shew William Huang
Principal Investigator

University of Nebraska Medical Center

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

Nicole Annette Shonka
Principal Investigator

New Hampshire
Lebanon

Dartmouth Hitchcock Medical Center

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

Alan Charles Hartford
Principal Investigator

New York
Rochester

Highland Hospital

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

University of Rochester

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Anna Shapiro
Ph: 315-464-5476

Anna Shapiro
Principal Investigator

North Dakota
Grand Forks

Altru Cancer Center

Grant Richard Seeger
Ph: 701-780-6520

Grant Richard Seeger
Principal Investigator

Ohio
Akron

Summa Akron City Hospital/Cooper Cancer Center

Jennifer Eileen Payne
Ph: 330-375-6101

Jennifer Eileen Payne
Principal Investigator

Barberton

Summa Barberton Hospital

Jennifer Eileen Payne
Ph: 330-375-6101

Jennifer Eileen Payne
Principal Investigator

Medina

Summa Health Center at Lake Medina

Jennifer Eileen Payne
Ph: 330-375-6101

Jennifer Eileen Payne
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

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

Terence S. Herman
Principal Investigator

Pennsylvania
Abington

Abington Memorial Hospital

Wayne H. Pinover
Ph: 215-481-2402

Wayne H. Pinover
Principal Investigator

Bethlehem

Saint Luke's University Hospital-Bethlehem Campus

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

Nimisha Deb
Principal Investigator

Hershey

Penn State Milton S Hershey Medical Center

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

Henry Wagner
Principal Investigator

Philadelphia

Thomas Jefferson University Hospital

Wenyin Shi
Ph: 215-955-6084

Wenyin Shi
Principal Investigator

West Reading

Reading Hospital

Albert Yuen
Ph: 610-988-9323

Albert Yuen
Principal Investigator

South Carolina
Charleston

Medical University of South Carolina

Scott Michael Lindhorst
Ph: 843-792-9321

Scott Michael Lindhorst
Principal Investigator

Greenville

Greenville Health System Cancer Institute-Eastside

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Faris

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greer

Greenville Health System Cancer Institute-Greer

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Seneca

Greenville Health System Cancer Institute-Seneca

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

South Dakota
Rapid City

Rapid City Regional Hospital

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

Michael J. Swartz
Principal Investigator

Texas
Austin

University Medical Center Brackenridge

Mateo Ziu
Ph: 512-324-7991

Mateo Ziu
Principal Investigator

Dallas

UT Southwestern/Simmons Cancer Center-Dallas

Edward Pan
Ph: 214-648-7097

Edward Pan
Principal Investigator

Galveston

University of Texas Medical Branch

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

Martin Colman
Principal Investigator

League City

UTMB Cancer Center at Victory Lakes

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

Martin Colman
Principal Investigator

Utah
Murray

Intermountain Medical Center

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Ogden

McKay-Dee Hospital Center

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Provo

Utah Valley Regional Medical Center

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Saint George

Dixie Medical Center Regional Cancer Center

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Salt Lake City

Huntsman Cancer Institute/University of Utah

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

Dennis Charles Shrieve
Principal Investigator

LDS Hospital

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Virginia
Richmond

Virginia Commonwealth University/Massey Cancer Center

Mark G. Malkin
Ph: 804-628-1939

Mark G. Malkin
Principal Investigator

Washington
Kennewick

Tri-Cities Cancer Center

George E. Laramore
Ph: 206-616-8289

George E. Laramore
Principal Investigator

Mount Vernon

Skagit Valley Hospital

George E. Laramore
Ph: 206-616-8289

George E. Laramore
Principal Investigator

Seattle

University of Washington Medical Center

George E. Laramore
Ph: 206-616-8289

George E. Laramore
Principal Investigator

Wisconsin
Madison

University of Wisconsin Hospital and Clinics

Steven Paul Howard
Ph: 877-405-6866

Steven Paul Howard
Principal Investigator

Milwaukee

Froedtert and the Medical College of Wisconsin

Christopher J. Schultz
Ph: 414-805-4380

Christopher J. Schultz
Principal Investigator

Waukesha

Waukesha Memorial Hospital

Wingate F. Clapper
Ph: 262-928-7632

Wingate F. Clapper
Principal Investigator

Canada

Alberta
Calgary

Tom Baker Cancer Centre

Robert Allan Nordal
Ph: 403-521-3433

Robert Allan Nordal
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00626990

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.