Radiation Therapy or Radiation Therapy and Temozolomide in Treating Patients with Newly Diagnosed Anaplastic Glioma or Low Grade Glioma

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Status: Active

Description

This randomized phase III trial compares giving radiation therapy alone or temozolomide together with radiation therapy and to see which works best in treating patients with newly diagnosed anaplastic glioma or low grade 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. It is not yet known whether giving radiation therapy alone or temozolomide together with radiation therapy is better in treating anaplastic glioma or low grade glioma.

Eligibility Criteria

Inclusion Criteria

  • PRE-REGISTRATION INCLUSION CRITERIA:
  • Patients must be willing to submit tissue samples for mandatory central pathology review submission and deletion status determination; it should be initiated as soon after surgery as possible
  • REGISTRATION INCLUSION CRITERIA:
  • Newly diagnosed and =< 3 months from surgical diagnosis
  • Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [World Health Organization (WHO) grade 2 or 3]), or low grade glioma (WHO grade 2), as determined by pre-registration central pathology review; 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 co-deleted low grade gliomas must also be considered "high risk" by clinical criteria utilized in Radiation Therapy Oncology Group (RTOG) 9802 and must be either: * Age >= 40 and any surgical therapy * Age < 40 and subtotal resection or biopsy
  • Tumor tissue must show co-deletion for the relevant portions of chromosomes 1p and 19q by fluorescence in situ hybridization (FISH) analysis, as defined by the testing laboratory
  • Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration; patient must have recovered from the effects of surgery
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet (PLTs) count >= 100,000/mm^3
  • Hemoglobin (Hgb) > 9.0 g/dL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN
  • Creatinine =< 1.5 x ULN
  • Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Willing and able to complete neurocognitive testing without assistance and the QOL by themselves or with assistance
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up during the active monitoring phase (that is, the active treatment and observation portion of the study)
  • Patient willing to provide tissue samples for correlative research purposes

Exclusion Criteria

  • Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of temozolomide treatments
  • Received any prior surgery, radiation therapy or chemotherapy for any central nervous system (CNS) neoplasm; Note: patients who have had a prior low grade glioma with/without surgery and who now have anaplastic glioma with no prior radiation or chemotherapy are eligible for the study
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study
  • Patients known to be human immunodeficiency virus (HIV) positive and currently receiving retroviral therapy; Note: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm
  • Other active malignancy within 5 years of registration; exceptions: non-melanotic skin cancer or carcinoma in situ of the cervix; Note: if there is a history of prior malignancy, the patient must not be receiving other specific treatment (other than hormonal therapy) for their cancer
  • History of myocardial infarction =< 6 months or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Recent history of hepatitis infection or treating physician determined that the patient would be at significant risk of reactivation of hepatitis

Locations & Contacts

Alabama

Providence Hospital
Status: Temporarily closed to accrual
Mobile, Alabama
Contact: Robert Andrew Gilbert
Phone: 251-435-3942
University of Alabama at Birmingham Cancer Center
Status: Active
Birmingham, Alabama
Contact: John B. Fiveash
Phone: 205-934-0309

Alaska

Alaska Oncology and Hematology LLC
Status: Active
Anchorage, Alaska
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Alaska Women's Cancer Care
Status: Active
Anchorage, Alaska
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Anchorage Associates in Radiation Medicine
Status: Active
Anchorage, Alaska
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Anchorage Oncology Centre
Status: Active
Anchorage, Alaska
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Katmai Oncology Group
Status: Active
Anchorage, Alaska
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Providence Alaska Medical Center
Status: Active
Anchorage, Alaska
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org

Arizona

Arizona Oncology Associates-Deer Valley Center
Status: Temporarily closed to accrual
Phoenix, Arizona
Contact: David G. Brachman
Phone: 800-360-6371
Arizona Oncology Services Foundation
Status: Temporarily closed to accrual
Scottsdale, Arizona
Contact: David G. Brachman
Phone: 800-360-6371
Saint Joseph's Hospital and Medical Center
Status: Active
Phoenix, Arizona
Contact: David G. Brachman
Phone: 800-360-6371

California

California Cancer Center - North Fresno
Status: Active
Fresno, California
Contact: Uzair Bashir Chaudhary
Phone: 559-256-9680
Cedars Sinai Medical Center
Status: Active
Los Angeles, California
Contact: Jethro Lisien Hu
Phone: 310-423-8965
Kaiser Permanente Los Angeles Medical Center
Status: Active
Los Angeles, California
Contact: Michael Raymond Girvigian
Phone: 626-564-3455
Memorial Medical Center
Status: Active
Modesto, California
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Mills-Peninsula Medical Center
Status: Active
Burlingame, California
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: Active
Auburn, California
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: Active
Cameron Park, California
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: Active
Roseville, California
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: Active
Vacaville, California
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sutter Medical Center Sacramento
Status: Active
Sacramento, California
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sutter Solano Medical Center / Cancer Center
Status: Active
Vallejo, California
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
UC San Diego Moores Cancer Center
Status: Active
La Jolla, California
Contact: David E. Piccioni
Phone: 858-822-5354 Email: cancercto@ucsd.edu
University Oncology Associates
Status: Active
Fresno, California
Contact: Uzair Bashir Chaudhary
Phone: 559-256-9680

Colorado

Littleton Adventist Hospital
Status: Active
Littleton, Colorado
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Longmont United Hospital
Status: Active
Longmont, Colorado
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
McKee Medical Center
Status: Temporarily closed to accrual
Loveland, Colorado
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Memorial Hospital Central
Status: Active
Colorado Springs, Colorado
Contact: Brian Dennis Kavanagh
Phone: 720-848-0650
Penrose-Saint Francis Healthcare
Status: Active
Colorado Springs, Colorado
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Porter Adventist Hospital
Status: Active
Denver, Colorado
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Saint Anthony Hospital
Status: Active
Lakewood, Colorado
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Saint Mary Corwin Medical Center
Status: Active
Pueblo, Colorado
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
The Medical Center of Aurora
Status: Temporarily closed to accrual
Aurora, Colorado
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Status: Active
Aurora, Colorado
Contact: Brian Dennis Kavanagh
Phone: 720-848-0650

Connecticut

Yale University
Status: Active
New Haven, Connecticut
Contact: Kevin Patrick Becker
Phone: 203-785-5702

District of Columbia

Sibley Memorial Hospital
Status: Active
Washington, District of Columbia
Contact: Matthias Holdhoff
Phone: 410-955-8804 Email: jhcccro@jhmi.edu

Florida

Baptist MD Anderson Cancer Center
Status: Temporarily closed to accrual
Jacksonville, Florida
Contact: Robert Cavaliere
Phone: 904-202-7051
Boca Raton Regional Hospital
Status: Active
Boca Raton, Florida
Contact: Sajeel Akbar Chowdhary
Phone: 561-955-4800
Mayo Clinic in Florida
Status: Active
Jacksonville, Florida
Contact: Paul D. Brown
Phone: 855-776-0015
University of Florida
Status: Active
Gainesville, Florida
Contact: David D. Tran
Phone: 352-273-8675 Email: trials@cancer.ufl.edu

Georgia

Piedmont Hospital
Status: Active
Atlanta, Georgia
Contact: Adam Wayne Nowlan
Phone: 404-425-7943 Email: ORS@piedmont.org

Idaho

Kootenai Cancer Center
Status: Active
Post Falls, Idaho
Contact: Benjamin T. Marchello
Phone: 800-648-6274

Illinois

Advocate Lutheran General Hospital
Status: Temporarily closed to accrual
Park Ridge, Illinois
Contact: Heather E. Leeper
Phone: 847-570-2109
Cancer Care Center of Decatur
Status: Active
Decatur, Illinois
Contact: James Lloyd Wade
Phone: 217-876-4740 Email: kcheek@dmhhs.org
Cancer Care Specialists of Illinois-Swansea
Status: Active
Swansea, Illinois
Contact: James Lloyd Wade
Phone: 217-876-4740 Email: kcheek@dmhhs.org
Crossroads Cancer Center
Status: Active
Effingham, Illinois
Contact: James Lloyd Wade
Phone: 217-876-4740 Email: kcheek@dmhhs.org
Decatur Memorial Hospital
Status: Active
Decatur, Illinois
Contact: James Lloyd Wade
Phone: 217-876-4740 Email: kcheek@dmhhs.org
Loyola University Medical Center
Status: Temporarily closed to accrual
Maywood, Illinois
Contact: Edward Melian
Phone: 708-226-4357
Northwestern University
Status: Temporarily closed to accrual
Chicago, Illinois
Contact: Priya Uday Kumthekar
Phone: 312-695-1301 Email: cancer@northwestern.edu
OSF Saint Francis Medical Center
Status: Active
Peoria, Illinois
Contact: James Lloyd Wade
Phone: 217-876-4740 Email: kcheek@dmhhs.org
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: Active
Pekin, Illinois
Contact: James Lloyd Wade
Phone: 217-876-4740 Email: kcheek@dmhhs.org
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: Active
Peoria, Illinois
Contact: James Lloyd Wade
Phone: 217-876-4740 Email: kcheek@dmhhs.org

Indiana

Memorial Hospital of South Bend
Status: Active
South Bend, Indiana
Contact: Thomas Joseph Reid
Phone: 800-284-7370
Memorial Regional Cancer Center Day Road
Status: Active
Mishawaka, Indiana
Contact: Thomas Joseph Reid
Phone: 800-284-7370
Parkview Hospital Randallia
Status: Active
Fort Wayne, Indiana
Contact: Brian K. Chang
Phone: 260-373-8888 Email: parkviewresearch@parkview.com

Iowa

Iowa Lutheran Hospital
Status: Active
Des Moines, Iowa
Contact: Robert J. Behrens
Phone: 515-282-2921
Iowa Methodist Medical Center
Status: Active
Des Moines, Iowa
Contact: Robert J. Behrens
Phone: 515-282-2921
Iowa-Wide Oncology Research Coalition NCORP
Status: Active
Des Moines, Iowa
Contact: Robert J. Behrens
Phone: 515-282-2921
McFarland Clinic PC-William R Bliss Cancer Center
Status: Temporarily closed to accrual
Ames, Iowa
Contact: Joseph James Merchant
Phone: 515-239-2621
Medical Oncology and Hematology Associates-Des Moines
Status: Active
Des Moines, Iowa
Contact: Robert J. Behrens
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: Active
Des Moines, Iowa
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Clive, Iowa
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Mercy Cancer Center-West Lakes
Status: Active
Clive, Iowa
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Mercy Medical Center - Des Moines
Status: Active
Des Moines, Iowa
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Mercy Medical Center-West Lakes
Status: Active
West Des Moines, Iowa
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Methodist West Hospital
Status: Active
West Des Moines, Iowa
Contact: Robert J. Behrens
Phone: 515-282-2921

Kentucky

Norton Hospital Pavilion and Medical Campus
Status: Temporarily closed to accrual
Louisville, Kentucky
Contact: Aaron C. Spalding
Phone: 502-629-2500

Maine

Maine Medical Center- Scarborough Campus
Status: Temporarily closed to accrual
Scarborough, Maine
Contact: Ian Jared Bristol
Phone: 207-396-8090 Email: wrighd@mmc.org
Maine Medical Center-Bramhall Campus
Status: Temporarily closed to accrual
Portland, Maine
Contact: Ian Jared Bristol
Phone: 207-396-8090 Email: wrighd@mmc.org

Maryland

Cancer Trials Support Unit
Status: Active
Rockville, Maryland
Contact: Kurt A. Jaeckle
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Baltimore, Maryland
Contact: Matthias Holdhoff
Phone: 410-955-8804 Email: jhcccro@jhmi.edu

Michigan

Henry Ford Hospital
Status: Temporarily closed to accrual
Detroit, Michigan
Contact: Robert Anthony Chapman
Phone: 313-916-1784
Mercy Health Saint Mary's
Status: Temporarily closed to accrual
Grand Rapids, Michigan
Contact: Gilbert D.A. Padula
Phone: 330-375-6101
Munson Medical Center
Status: Temporarily closed to accrual
Traverse City, Michigan
Contact: Gilbert D.A. Padula
Phone: 330-375-6101
Spectrum Health at Butterworth Campus
Status: Temporarily closed to accrual
Grand Rapids, Michigan
Contact: Gilbert D.A. Padula
Phone: 330-375-6101
University of Michigan Comprehensive Cancer Center
Status: Active
Ann Arbor, Michigan
Contact: Daniel Eidelberg Spratt
Phone: 800-865-1125
West Michigan Cancer Center
Status: Active
Kalamazoo, Michigan
Contact: Sunil Nagpal
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
William Beaumont Hospital - Troy
Status: Temporarily closed to accrual
Troy, Michigan
Contact: Peter Y. Chen
Phone: 248-551-7695
William Beaumont Hospital-Royal Oak
Status: Temporarily closed to accrual
Royal Oak, Michigan
Contact: Peter Y. Chen
Phone: 248-551-7695

Minnesota

Abbott-Northwestern Hospital
Status: Active
Minneapolis, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Essentia Health Cancer Center
Status: Active
Duluth, Minnesota
Contact: Bret E.B. Friday
Phone: 888-203-7267
Fairview Ridges Hospital
Status: Active
Burnsville, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Fairview-Southdale Hospital
Status: Active
Edina, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Active
Minneapolis, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Lakeview Hospital
Status: Active
Stillwater, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Mayo Clinic
Status: Active
Rochester, Minnesota
Contact: Paul D. Brown
Phone: 855-776-0015
Mercy Hospital
Status: Active
Coon Rapids, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Miller-Dwan Hospital
Status: Active
Duluth, Minnesota
Contact: Bret E.B. Friday
Phone: 888-203-7267
Minnesota Oncology Hematology PA-Maplewood
Status: Active
Maplewood, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Woodbury, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
North Memorial Medical Health Center
Status: Active
Robbinsdale, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Park Nicollet Clinic - Saint Louis Park
Status: Active
Saint Louis Park, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Regions Hospital
Status: Active
Saint Paul, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Rice Memorial Hospital
Status: Active
Willmar, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Ridgeview Medical Center
Status: Active
Waconia, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Saint Francis Regional Medical Center
Status: Active
Shakopee, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: Active
Maplewood, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Saint Paul, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Unity Hospital
Status: Active
Fridley, Minnesota
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com

Missouri

Saint Francis Medical Center
Status: Active
Cape Girardeau, Missouri
Contact: James Lloyd Wade
Phone: 217-876-4740 Email: kcheek@dmhhs.org
Washington University School of Medicine
Status: Active
Saint Louis, Missouri
Contact: Jian Li Campian
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Montana

Billings Clinic Cancer Center
Status: Active
Billings, Montana
Contact: Benjamin T. Marchello
Phone: 800-648-6274
Saint Vincent Healthcare
Status: Active
Billings, Montana
Contact: Benjamin T. Marchello
Phone: 800-648-6274

Nebraska

Alegent Health Bergan Mercy Medical Center
Status: Active
Omaha, Nebraska
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Alegent Health Immanuel Medical Center
Status: Active
Omaha, Nebraska
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Alegent Health Lakeside Hospital
Status: Active
Omaha, Nebraska
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
CHI Health Good Samaritan
Status: Active
Kearney, Nebraska
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
CHI Health Saint Francis
Status: Active
Grand Island, Nebraska
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Midlands Community Hospital
Status: Temporarily closed to accrual
Papillion, Nebraska
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Missouri Valley Cancer Consortium
Status: Active
Omaha, Nebraska
Contact: Gamini S. Soori
Phone: 402-991-8070ext202 Email: mwilwerding@mvcc.cc
Oncology Hematology West
Status: Active
Omaha, Nebraska
Contact: Gamini S. Soori
Phone: 402-393-3110
University of Nebraska Medical Center
Status: Active
Omaha, Nebraska
Contact: Nicole Annette Shonka
Phone: 402-559-6941 Email: unmcrsa@unmc.edu

Nevada

21st Century Oncology
Status: Active
Las Vegas, Nevada
Contact: John Allan Ellerton
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: Active
Las Vegas, Nevada
Contact: John Allan Ellerton
Phone: 702-384-0013
Renown Regional Medical Center
Status: Active
Reno, Nevada
Contact: John Allan Ellerton
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: Active
Reno, Nevada
Contact: John Allan Ellerton
Phone: 702-384-0013

New Hampshire

Dartmouth Hitchcock Medical Center
Status: Temporarily closed to accrual
Lebanon, New Hampshire
Contact: Paula K. Rauschkolb
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New Jersey

Rutgers Cancer Institute of New Jersey
Status: Temporarily closed to accrual
New Brunswick, New Jersey
Contact: Sabin Bhagwan Motwani
Phone: 732-235-8675
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Temporarily closed to accrual
New Brunswick, New Jersey
Contact: Sabin Bhagwan Motwani
Phone: 732-235-8675

New Mexico

University of New Mexico Cancer Center
Status: Active
Albuquerque, New Mexico
Contact: Olivier Rixe
Phone: 505-925-0366 Email: LByatt@nmcca.org

New York

Highland Hospital
Status: Active
Rochester, New York
Contact: Yuhchyau Chen
Phone: 585-275-5830
New York-Presbyterian / Brooklyn Methodist Hospital
Status: Active
Brooklyn, New York
Contact: Sameer Rafla-Demetrious
Phone: 718-780-3677 Email: Adg9003@nyp.org
University of Rochester
Status: Active
Rochester, New York
Contact: Yuhchyau Chen
Phone: 585-275-5830

North Carolina

Wake Forest University Health Sciences
Status: Active
Winston-Salem, North Carolina
Contact: Glenn J. Lesser
Phone: 336-713-6771

North Dakota

Altru Cancer Center
Status: Active
Grand Forks, North Dakota
Contact: Grant Richard Seeger
Phone: 701-780-6520

Ohio

Case Western Reserve University
Status: Temporarily closed to accrual
Cleveland, Ohio
Contact: Joseph Gibbons
Phone: 800-641-2422
Cleveland Clinic Foundation
Status: Active
Cleveland, Ohio
Contact: Samuel Tay Chao
Phone: 866-223-8100
Cleveland Clinic Wooster Family Health and Surgery Center
Status: Active
Wooster, Ohio
Contact: Samuel Tay Chao
Phone: 866-223-8100
Hillcrest Hospital Cancer Center
Status: Active
Mayfield Heights, Ohio
Contact: Samuel Tay Chao
Phone: 866-223-8100
Mount Carmel Health Center West
Status: Active
Columbus, Ohio
Contact: Timothy David Moore
Phone: 614-488-2745 Email: sheree@columbusccop.org
Riverside Methodist Hospital
Status: Active
Columbus, Ohio
Contact: Timothy David Moore
Phone: 614-488-2745 Email: sheree@columbusccop.org
Saint Ann's Hospital
Status: Active
Westerville, Ohio
Contact: Timothy David Moore
Phone: 614-488-2745 Email: sheree@columbusccop.org
The Mark H Zangmeister Center
Status: Active
Columbus, Ohio
Contact: Timothy David Moore
Phone: 614-488-2745 Email: sheree@columbusccop.org

Oklahoma

University of Oklahoma Health Sciences Center
Status: Active
Oklahoma City, Oklahoma
Contact: Terence S. Herman
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

Clackamas Radiation Oncology Center
Status: Active
Clackamas, Oregon
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Providence Portland Medical Center
Status: Active
Portland, Oregon
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Portland, Oregon
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org

Pennsylvania

Abington Memorial Hospital
Status: Active
Abington, Pennsylvania
Contact: Willard G. Andrews
Phone: 215-481-2402
Geisinger Medical Center
Status: Active
Danville, Pennsylvania
Contact: Scott G. Turner
Phone: 570-271-5251
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Wilkes-Barre, Pennsylvania
Contact: Scott G. Turner
Phone: 570-271-5251
Lehigh Valley Hospital-Cedar Crest
Status: Temporarily closed to accrual
Allentown, Pennsylvania
Contact: Suresh G. Nair
Phone: 610-402-2273
Saint Luke's University Hospital-Bethlehem Campus
Status: Active
Bethlehem, Pennsylvania
Contact: Hugh D. Moulding
Phone: 610-954-3582 Email: infolink@slhn.org
Temple University Hospital
Status: Active
Philadelphia, Pennsylvania
Contact: Aruna Padmanabhan
Phone: 215-728-2983
Thomas Jefferson University Hospital
Status: Active
Philadelphia, Pennsylvania
Contact: Jon Glass
Phone: 215-955-6084
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Pittsburgh, Pennsylvania
Contact: David Anthony Clump
Phone: 412-621-2334

South Carolina

Greenville Health System Cancer Institute-Andrews
Status: Temporarily closed to accrual
Greenville, South Carolina
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greenville Health System Cancer Institute-Butternut
Status: Temporarily closed to accrual
Greenville, South Carolina
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greenville Health System Cancer Institute-Eastside
Status: Active
Greenville, South Carolina
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greenville Health System Cancer Institute-Faris
Status: Active
Greenville, South Carolina
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greenville Health System Cancer Institute-Greer
Status: Active
Greer, South Carolina
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greenville Health System Cancer Institute-Seneca
Status: Active
Seneca, South Carolina
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Spartanburg, South Carolina
Contact: David Lawrence Grisell
Phone: 864-241-6251

South Dakota

Rapid City Regional Hospital
Status: Active
Rapid City, South Dakota
Contact: Joshua Cole Lukenbill
Phone: 605-716-3982 Email: research@rcrh.org

Tennessee

Vanderbilt University / Ingram Cancer Center
Status: Active
Nashville, Tennessee
Contact: Paul L. Moots
Phone: 800-811-8480

Texas

University of Texas Medical Branch
Status: Active
Galveston, Texas
Contact: Martin Colman
Phone: 409-772-1950 Email: clinical.research@utmb.edu
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Dallas, Texas
Contact: Edward Pan
Phone: 214-648-7097
UTMB Cancer Center at Victory Lakes
Status: Active
League City, Texas
Contact: Martin Colman
Phone: 409-772-1950 Email: clinical.research@utmb.edu

Utah

Dixie Medical Center Regional Cancer Center
Status: Active
Saint George, Utah
Contact: Gordon A. Watson
Phone: 317-356-2422
Huntsman Cancer Institute / University of Utah
Status: Active
Salt Lake City, Utah
Contact: Adam Louis Cohen
Phone: 801-581-4477 Email: clinical.trials@hci.utah.edu
Intermountain Medical Center
Status: Active
Murray, Utah
Contact: Gordon A. Watson
Phone: 317-356-2422
LDS Hospital
Status: Active
Salt Lake City, Utah
Contact: Gordon A. Watson
Phone: 317-356-2422
Sandra L Maxwell Cancer Center
Status: Active
Cedar City, Utah
Contact: Gordon A. Watson
Phone: 317-356-2422
Utah Cancer Specialists-Salt Lake City
Status: Active
Salt Lake City, Utah
Contact: Gordon A. Watson
Phone: 317-356-2422
Utah Valley Regional Medical Center
Status: Active
Provo, Utah
Contact: Gordon A. Watson
Phone: 317-356-2422

Virginia

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

Washington

Fred Hutchinson Cancer Research Center
Status: Active
Seattle, Washington
Contact: George E. Laramore
Phone: 206-616-8289
Kadlec Clinic Hematology and Oncology
Status: Active
Kennewick, Washington
Contact: George E. Laramore
Phone: 206-616-8289
PeaceHealth Saint Joseph Medical Center
Status: Active
Bellingham, Washington
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
PeaceHealth Southwest Medical Center
Status: Active
Vancouver, Washington
Contact: Alison Katherine Conlin
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Seattle Cancer Care Alliance
Status: Active
Seattle, Washington
Contact: George E. Laramore
Phone: 206-616-8289
Skagit Valley Hospital
Status: Active
Mount Vernon, Washington
Contact: George E. Laramore
Phone: 206-616-8289
Skagit Valley Hospital Regional Cancer Care Center
Status: Active
Mount Vernon, Washington
Contact: George E. Laramore
Phone: 206-616-8289
Tri-Cities Cancer Center
Status: Active
Kennewick, Washington
Contact: George E. Laramore
Phone: 206-616-8289
University of Washington Medical Center
Status: Active
Seattle, Washington
Contact: George E. Laramore
Phone: 206-616-8289
Virginia Mason Medical Center
Status: Active
Seattle, Washington
Contact: Craig R. Nichols
Phone: 801-507-3950

West Virginia

West Virginia University Healthcare
Status: Active
Morgantown, West Virginia
Contact: Aaron P. Provenzano
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Aurora Saint Luke's Medical Center
Status: Temporarily closed to accrual
Milwaukee, Wisconsin
Contact: George Corneliu Bobustuc
Phone: 414-649-5717
Froedtert and the Medical College of Wisconsin
Status: Active
Milwaukee, Wisconsin
Contact: Joseph A. Bovi
Phone: 414-805-4380
Gundersen Lutheran Medical Center
Status: Active
La Crosse, Wisconsin
Contact: Collin D. Driscoll
Phone: 608-775-2385 Email: cancerctr@gundersenhealth.org
ProHealth Waukesha Memorial Hospital
Status: Temporarily closed to accrual
Waukesha, Wisconsin
Contact: Timothy Robert Wassenaar
Phone: 262-928-5539 Email: Chanda.miller@phci.org

Alberta

Tom Baker Cancer Centre
Status: Active
Calgary, Alberta
Contact: Roger Y Tsang
Phone: 403-521-3433

Ontario

Odette Cancer Centre- Sunnybrook Health Sciences Centre
Status: Active
Toronto, Ontario
Contact: James J. Perry
Phone: 215-612-5296
Ottawa Hospital and Cancer Center-General Campus
Status: Temporarily closed to accrual
Ottawa, Ontario
Contact: Garth Nicholas
Phone: 613-761-4395 Email: info@ohri.ca
University Health Network-Princess Margaret Hospital
Status: Active
Toronto, Ontario
Contact: Warren P. Mason
Phone: 416-946-4501 Email: clinical.trials@uhn.on.ca

Quebec

CHUM - Hopital Notre-Dame
Status: Active
Montreal, Quebec
Contact: Giuseppina Laura Masucci
Phone: 514-890-8000ext23611 Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

Saskatchewan

Allan Blair Cancer Centre
Status: Active
Regina, Saskatchewan
Contact: Mussawar Iqbal
Phone: 306-766-2213

Austria

Medical University Vienna
Status: Active
Vienna
Contact: Kurt A. Jaeckle

Belgium

Alegemeen Ziekenhuis Middelheim
Status: Active
Antwerpen
Contact: Kurt A. Jaeckle
Phone: 904-953-7102 Email: jaeckle.kurt@mayo.edu

France

Centre Antoine Lacassagne
Status: Active
Nice
Contact: Kurt A. Jaeckle
Phone: 904-953-7102 Email: jaeckle.kurt@mayo.edu
Centre Leon Berard
Status: Active
Lyon
Contact: Kurt A. Jaeckle
Gustave Roussy
Status: Active
Villejuif
Contact: Kurt A. Jaeckle

Netherlands

Erasmus University Medical Center
Status: Active
Rotterdam
Contact: Kurt A. Jaeckle
Maastro Clinic-Maastricht Radiation Oncology
Status: Active
Maastricht
Contact: Kurt A. Jaeckle
Phone: 904-953-7102 Email: jaeckle.kurt@mayo.edu
University Medical Center Groningen
Status: Active
Groningen
Contact: Kurt A. Jaeckle
Vrije Universiteit Medisch Centrum
Status: Active
Amsterdam
Contact: Kurt A. Jaeckle

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide (radiation therapy [RT] + temozolomide [TMZ] → TMZ) (ARM B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by adjuvant procarbazine hydrochloride, lomustine, vincristine sulfate (PCV) chemotherapy (RT → PCV) (ARM A).

SECONDARY OBJECTIVES:

I. To determine whether patients who receive temozolomide RT + TMZ → TMZ have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant chemotherapy (RT → PCV).

II. To determine whether there is a difference in survival based on t(1;19)(q10,p10) translocation status and O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter hypermethylation status.

III. To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life.

IV. To determine the toxicity of the treatment in each arm and perform descriptive comparisons.

V. To determine the neurocognitive and quality of life (QOL) effects in patients treated on this protocol and correlate these results with outcome endpoints.

VI. To store blood products (i.e., plasma, DNA, and buffy coat), tumor tissue and magnetic resonance imaging (MRI)/computed tomography (CT) images for future scientific investigations.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) on days 1-5. Patients also receive procarbazine hydrochloride orally (PO) on days 8-21, lomustine PO on day 1 and vincristine sulfate intravenously (IV) on days 8 and 29 of courses 3-8 for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo IMRT as in Arm A and receive temozolomide PO once daily (QD) on days 1-5 for 6 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide PO QD on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for 6-12 courses in the absence of disease progression and unacceptable toxicity.

After completion of study therapy, patients are followed up every 12 weeks for 1 year, every 4 months for 2 years, and then every 6 months thereafter.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Kurt A. Jaeckle

Trial IDs

Primary ID N0577
Secondary IDs NCI-2011-01915, NCCTG-N0577, EudraCT-2008-007295-14, EORTC-26081-22086, CDR0000640442
Clinicaltrials.gov ID NCT00887146

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