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:
  • United States (US) and Canadian sites: * This review is mandatory prior to registration to confirm eligibility; patients must be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible
  • Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review * Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility, the 1p/19q analysis results will be accepted from the local site, as determined by either a locally available or reference laboratory (for US, must be Clinical Laboratory Improvement Act [CLIA] certified); acceptable methods for determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by genomic sequencing or methylomic analyses; US and Canadian sites must send a copy of the official report to the pathology coordinator and quality assurance specialist (QAS) * Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic analyses; this should be performed at the local site (US: performed in a CLIA certified laboratory); the site must send a copy of the official report to the pathology coordinator and QAS
  • REGISTRATION INCLUSION CRITERIA:
  • Newly diagnosed and =< 3 months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure > 3 months earlier for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy
  • Histological evidence of World Health Organization (WHO) grade III anaplastic glioma or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced laboratory qualified for the study * 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 codeleted low grade gliomas must also be considered “high risk” by exhibiting one or more of the following characteristics: * Age >= 40 and any surgical therapy * Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection) * Documented growth following prior surgery (NOTE: patients with prior surgery cannot have received prior radiation, chemotherapy or targeted therapy) * Intractable seizures
  • Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery
  • Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to registration
  • Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration
  • Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registration
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN obtained =< 21 days prior to registration
  • Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration
  • Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
  • Written informed consent
  • Willingness to return to enrolling institution for follow-up during the active monitoring phase (that is, the active treatment and observation portion) of the study); patients who have been formally transferred to another active and approved site participating in this study would not need to return to the enrolling institution for this purpose
  • Willingness to allow the provision of tissue samples for correlative research, as long as adequate tissues are available; patients will not be excluded from participation in the study, if they are willing to allow provision of tissues for the correlative research, but there are insufficient quantities of tissue for the correlative analyses (e.g., a patient otherwise eligible and willing who had biopsy only) Willingness to allow the provision of blood samples for correlative research; patients are not excluded from participation in the study, if they are willing to provide the mandatory biospecimens for translational/correlative research, but for logistical reasons the specimens(s) were not obtainable or if the volume collected was insufficient

Exclusion Criteria

  • The following categories are ineligible: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception or contraceptive method during this study and 6 months following the completion of chemotherapy treatments
  • History of prior radiation therapy or chemotherapy for glioma; note: patients who have a history of prior low grade glioma (with or without a distant history of prior surgery for that glioma), but who have never received prior chemotherapy or radiation therapy for the glioma 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 are not eligible; 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 is not eligible if they are receiving other specific treatment (with the exclusion of hormonal therapy or Her-2 inhibitors) for their cancer or if they have received prior total body irradiation which included the brain
  • 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 if the treating physician determined that the patient would be at significant risk of reactivation of hepatitis

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: John B. Fiveash
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org
Mobile
Providence Hospital
Status: Temporarily closed to accrual
Contact: Robert Andrew Gilbert
Phone: 888-823-5923 Email: ctsucontact@westat.com

Alaska

Anchorage
Alaska Oncology and Hematology LLC
Status: Active
Contact: Alison Katherine Conlin
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
Status: Active
Contact: Alison Katherine Conlin
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org
Anchorage Associates in Radiation Medicine
Status: Active
Contact: Alison Katherine Conlin
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
Status: Active
Contact: Alison Katherine Conlin
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Active
Contact: Alison Katherine Conlin
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Active
Contact: Alison Katherine Conlin
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Phoenix
Arizona Oncology Associates-Deer Valley Center
Status: Temporarily closed to accrual
Contact: David G. Brachman
Phone: 800-360-6371
Saint Joseph's Hospital and Medical Center
Status: Active
Contact: David G. Brachman
Phone: 888-823-5923 Email: ctsucontact@westat.com
Scottsdale
Arizona Oncology Services Foundation
Status: Temporarily closed to accrual
Contact: David G. Brachman
Phone: 800-360-6371

California

Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: Active
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Burlingame
Mills-Peninsula Medical Center
Status: Active
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: Active
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Fresno
California Cancer Center - North Fresno
Status: Active
Contact: Uzair Bashir Chaudhary
Phone: 559-447-4050
University Oncology Associates
Status: Active
Contact: Uzair Bashir Chaudhary
Phone: 559-256-9680
La Jolla
UC San Diego Moores Cancer Center
Status: Temporarily closed to accrual
Contact: David E. Piccioni
Phone: 858-822-5354 Email: cancercto@ucsd.edu
Los Angeles
Cedars Sinai Medical Center
Status: Active
Contact: Jethro Lisien Hu
Phone: 310-423-8965
Kaiser Permanente Los Angeles Medical Center
Status: Active
Contact: Michael Raymond Girvigian
Phone: 626-564-3455
Modesto
Memorial Medical Center
Status: Active
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Oakland
Kaiser Permanente Oakland-Broadway
Status: Temporarily closed to accrual
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: Active
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Temporarily closed to accrual
Contact: Louis Fehrenbacher
Phone: 626-564-3455
South San Francisco
Kaiser Permanente-South San Francisco
Status: Temporarily closed to accrual
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: Active
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Vallejo
Sutter Solano Medical Center / Cancer Center
Status: Active
Contact: Stacy D. D'Andre
Phone: 415-209-2686 Email: bernicl@sutterhealth.org

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Brian Dennis Kavanagh
Phone: 720-848-0650
Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Denver
Porter Adventist Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Lakewood
Saint Anthony Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Littleton
Littleton Adventist Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Longmont
Longmont United Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Loveland
McKee Medical Center
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Pueblo
Saint Mary Corwin Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org

Connecticut

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

District of Columbia

Washington
Sibley Memorial Hospital
Status: Temporarily closed to accrual
Contact: Matthias Holdhoff
Phone: 202-243-2373

Florida

Boca Raton
Boca Raton Regional Hospital
Status: Active
Contact: Sajeel Akbar Chowdhary
Phone: 561-955-4800
Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: David D. Tran
Phone: 888-823-5923 Email: ctsucontact@westat.com
Jacksonville
Baptist MD Anderson Cancer Center
Status: Temporarily closed to accrual
Contact: Alton Venson Hallum
Phone: 904-202-7051
Mayo Clinic in Florida
Status: Temporarily closed to accrual
Contact: Paul D. Brown
Phone: 855-776-0015

Georgia

Atlanta
Piedmont Hospital
Status: Temporarily closed to accrual
Contact: Adam Wayne Nowlan
Phone: 404-425-7943 Email: ORS@piedmont.org

Idaho

Post Falls
Kootenai Cancer Center
Status: Temporarily closed to accrual
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org

Illinois

Chicago
Northwestern University
Status: Temporarily closed to accrual
Contact: Priya Uday Kumthekar
Phone: 312-695-1301 Email: cancer@northwestern.edu
University of Chicago Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Martin Kelly Nicholas
Phone: 312-355-3046
Decatur
Cancer Care Center of Decatur
Status: Active
Contact: James Lloyd Wade
Phone: 217-876-4740 Email: kcheek@dmhhs.org
Decatur Memorial Hospital
Status: Active
Contact: James Lloyd Wade
Phone: 217-876-6601
Effingham
Crossroads Cancer Center
Status: Active
Contact: James Lloyd Wade
Phone: 217-342-2066
Maywood
Loyola University Medical Center
Status: Temporarily closed to accrual
Contact: Edward Melian
Phone: 708-226-4357
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: Active
Contact: James Lloyd Wade
Phone: 309-353-0512
Peoria
OSF Saint Francis Medical Center
Status: Active
Contact: James Lloyd Wade
Phone: 309-655-3258
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: Active
Contact: James Lloyd Wade
Phone: 609-599-5179
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: James Lloyd Wade
Phone: 217-876-4755 Email: pwisher@dmhhs.org

Indiana

Fort Wayne
Parkview Hospital Randallia
Status: Temporarily closed to accrual
Contact: Brian K. Chang
Phone: 260-373-8888 Email: parkviewresearch@parkview.com
Mishawaka
Memorial Regional Cancer Center Day Road
Status: Active
Contact: Thomas Joseph Reid
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org
South Bend
Memorial Hospital of South Bend
Status: Active
Contact: Thomas Joseph Reid
Phone: 800-284-7370

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Contact: Mehmet Sitki Copur
Phone: 515-247-3970
Mercy Cancer Center-West Lakes
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Des Moines
Broadlawns Medical Center
Status: Active
Contact: Robert J. Behrens
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org
Iowa Lutheran Hospital
Status: Active
Contact: Robert J. Behrens
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: Active
Contact: Robert J. Behrens
Phone: 515-241-6727
Iowa-Wide Oncology Research Coalition NCORP
Status: Active
Contact: Robert J. Behrens
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Des Moines
Status: Active
Contact: Robert J. Behrens
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: Active
Contact: Mehmet Sitki Copur
Phone: 515-247-3970
Mercy Medical Center - Des Moines
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-221-4849
West Des Moines
Mercy Medical Center-West Lakes
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Methodist West Hospital
Status: Active
Contact: Robert J. Behrens
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: John Lee Villano
Phone: 859-257-3379
Louisville
Norton Hospital Pavilion and Medical Campus
Status: Active
Contact: Aaron C. Spalding
Phone: 502-629-2500

Maryland

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

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: Temporarily closed to accrual
Contact: Helen A. Shih
Phone: 877-726-5130

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Michelle Miran Kim
Phone: 800-865-1125
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Sunil Nagpal
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org

Minnesota

Burnsville
Fairview Ridges Hospital
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Duluth
Essentia Health Cancer Center
Status: Active
Contact: Bret E.B. Friday
Phone: 218-786-3308
Miller-Dwan Hospital
Status: Active
Contact: Bret E.B. Friday
Phone: 888-203-7267
Edina
Fairview-Southdale Hospital
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: Active
Contact: Daniel M. Anderson
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Contact: Paul D. Brown
Phone: 855-776-0015
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Stillwater
Lakeview Hospital
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Waconia
Ridgeview Medical Center
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: Daniel M. Anderson
Phone: 952-993-1517 Email: mmcorc@healthpartners.com

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: James Lloyd Wade
Phone: 573-334-2230 Email: sfmc@sfmc.net
Saint Louis
Washington University School of Medicine
Status: Active
Contact: Jian Li Campian
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Montana

Billings
Billings Clinic Cancer Center
Status: Temporarily closed to accrual
Contact: Benjamin T. Marchello
Phone: 800-996-2663 Email: research@billingsclinic.org
Saint Vincent Healthcare
Status: Temporarily closed to accrual
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org

Nebraska

Grand Island
CHI Health Saint Francis
Status: Active
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Kearney
CHI Health Good Samaritan
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Lincoln
Southeast Nebraska Cancer Center
Status: Active
Contact: Gamini S. Soori
Phone: 402-327-7363
Omaha
Alegent Health Bergan Mercy Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 402-398-6060
Alegent Health Immanuel Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 402-343-8511 Email: research@alegent.org
Alegent Health Lakeside Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Missouri Valley Cancer Consortium
Status: Active
Contact: Gamini S. Soori
Phone: 402-991-8070ext202 Email: mwilwerding@mvcc.cc
Nebraska Cancer Specialists - Omaha
Status: Active
Contact: Gamini S. Soori
Phone: 402-393-3110
University of Nebraska Medical Center
Status: Temporarily closed to accrual
Contact: Nicole Annette Shonka
Phone: 402-559-6941 Email: unmcrsa@unmc.edu
Papillion
Midlands Community Hospital
Status: Temporarily closed to accrual
Contact: Mehmet Sitki Copur
Phone: 501-622-2100
Scottsbluff
Regional West Medical Center Cancer Center
Status: Active
Contact: Gamini S. Soori
Phone: 308-630-2429

Nevada

Las Vegas
21st Century Oncology
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013
Reno
Renown Regional Medical Center
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: Active
Contact: John Allan Ellerton
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org

New Jersey

Summit
Overlook Hospital
Status: Temporarily closed to accrual
Contact: Kurt A. Jaeckle
Phone: 908-522-2043

New Mexico

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

New York

Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: Temporarily closed to accrual
Contact: Sameer Rafla-Demetrious
Phone: 718-780-3677 Email: Adg9003@nyp.org
New York
Columbia University / Herbert Irving Cancer Center
Status: Active
Contact: Andrew B. Lassman
Phone: 212-305-8615
Rochester
Highland Hospital
Status: Temporarily closed to accrual
Contact: Yuhchyau Chen
Phone: 585-341-8113
University of Rochester
Status: Temporarily closed to accrual
Contact: Yuhchyau Chen
Phone: 585-275-5830
Syracuse
State University of New York Upstate Medical University
Status: Temporarily closed to accrual
Contact: Anna Shapiro
Phone: 315-464-5476

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: Temporarily closed to accrual
Contact: Glenn J. Lesser
Phone: 336-713-6771

North Dakota

Grand Forks
Altru Cancer Center
Status: Temporarily closed to accrual
Contact: Grant Richard Seeger
Phone: 701-780-6520

Ohio

Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Samuel Tay Chao
Phone: 866-223-8100
Columbus
Mount Carmel Health Center West
Status: Active
Contact: Timothy David Moore
Phone: 614-234-5433
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Vinay K. Puduvalli
Phone: 800-293-5066 Email: Jamesline@osumc.edu
Riverside Methodist Hospital
Status: Active
Contact: Timothy David Moore
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: Active
Contact: Timothy David Moore
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: Active
Contact: Samuel Tay Chao
Phone: 440-312-4293 Email: hugneyc@cchseast.org
Sylvania
Flower Hospital
Status: Active
Contact: Abhijit B. Saste
Phone: 419-824-1842
Westerville
Saint Ann's Hospital
Status: Active
Contact: Timothy David Moore
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: Active
Contact: Samuel Tay Chao
Phone: 800-862-7798

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Terence S. Herman
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: Active
Contact: Terence S. Herman
Phone: 918-505-3200

Oregon

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

Pennsylvania

Abington
Abington Memorial Hospital
Status: Active
Contact: Willard G. Andrews
Phone: 215-481-2402
Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Temporarily closed to accrual
Contact: Suresh G. Nair
Phone: 610-402-2273
Bethlehem
Saint Luke's University Hospital-Bethlehem Campus
Status: Active
Contact: Hugh D. Moulding
Phone: 888-823-5923 Email: ctsucontact@westat.com
Danville
Geisinger Medical Center
Status: Active
Contact: Na Tosha N. Gatson
Phone: 570-271-5251
Philadelphia
Temple University Hospital
Status: Active
Contact: Aruna Padmanabhan
Phone: 215-728-2983
Thomas Jefferson University Hospital
Status: Active
Contact: Jon Glass
Phone: 215-955-6084
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: David Anthony Clump
Phone: 412-647-8073
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Na Tosha N. Gatson
Phone: 570-271-5251

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Scott Michael Lindhorst
Phone: 843-792-9321
Greenville
Greenville Health System Cancer Institute-Andrews
Status: Temporarily closed to accrual
Contact: David Lawrence Grisell
Phone: 864-679-3966
Greenville Health System Cancer Institute-Butternut
Status: Temporarily closed to accrual
Contact: David Lawrence Grisell
Phone: 864-679-3966
Greenville Health System Cancer Institute-Eastside
Status: Temporarily closed to accrual
Contact: David Lawrence Grisell
Phone: 864-679-3966
Greenville Health System Cancer Institute-Faris
Status: Temporarily closed to accrual
Contact: David Lawrence Grisell
Phone: 864-241-6251
Greer
Greenville Health System Cancer Institute-Greer
Status: Temporarily closed to accrual
Contact: David Lawrence Grisell
Phone: 864-241-6251
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Temporarily closed to accrual
Contact: David Lawrence Grisell
Phone: 864-241-6251
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Temporarily closed to accrual
Contact: David Lawrence Grisell
Phone: 864-241-6251

South Dakota

Rapid City
Rapid City Regional Hospital
Status: Active
Contact: Michael O. Robinson
Phone: 605-716-3982 Email: research@rcrh.org

Tennessee

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

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Temporarily closed to accrual
Contact: Edward Pan
Phone: 214-648-7097
Galveston
University of Texas Medical Branch
Status: Temporarily closed to accrual
Contact: Todd Allen Swanson
Phone: 409-772-1950 Email: clinical.research@utmb.edu
League City
UTMB Cancer Center at Victory Lakes
Status: Temporarily closed to accrual
Contact: Todd Allen Swanson
Phone: 800-917-8906

Utah

Cedar City
Sandra L Maxwell Cancer Center
Status: Active
Contact: Gordon A. Watson
Phone: 435-868-5680
Murray
Intermountain Medical Center
Status: Active
Contact: Gordon A. Watson
Phone: 801-507-3950
Provo
Utah Valley Regional Medical Center
Status: Active
Contact: Gordon A. Watson
Phone: 801-357-7965
Saint George
Dixie Medical Center Regional Cancer Center
Status: Active
Contact: Gordon A. Watson
Phone: 435-688-4167
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Adam Louis Cohen
Phone: 801-581-4477 Email: clinical.trials@hci.utah.edu
LDS Hospital
Status: Active
Contact: Gordon A. Watson
Phone: 801-408-1347
Utah Cancer Specialists-Salt Lake City
Status: Active
Contact: Gordon A. Watson
Phone: 801-933-6070 Email: research@utahcancer.com

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Mark G. Malkin
Phone: 773-702-9171 Email: protocols@AllianceNCTN.org

Washington

Bellingham
PeaceHealth Saint Joseph Medical Center
Status: Active
Contact: Alison Katherine Conlin
Phone: 360-715-4133 Email: cpatz@peacehealth.org
Kennewick
Kadlec Clinic Hematology and Oncology
Status: Active
Contact: Alison Katherine Conlin
Phone: 509-783-4637 Email: research@cbho.org
Tri-Cities Cancer Center
Status: Temporarily closed to accrual
Contact: George E. Laramore
Phone: 800-377-0856
Mount Vernon
Skagit Valley Hospital
Status: Temporarily closed to accrual
Contact: George E. Laramore
Phone: 360-814-2687 Email: rcccclinicalresearch@skagitvalleyhospital.org
Skagit Valley Hospital Regional Cancer Care Center
Status: Temporarily closed to accrual
Contact: George E. Laramore
Phone: 360-814-2146 Email: rcccclinicalresearch@skagitvalleyhospital.org
Seattle
Fred Hutchinson Cancer Research Center
Status: Temporarily closed to accrual
Contact: George E. Laramore
Phone: 800-422-6237
Seattle Cancer Care Alliance
Status: Temporarily closed to accrual
Contact: George E. Laramore
Phone: 800-804-8824
University of Washington Medical Center
Status: Temporarily closed to accrual
Contact: George E. Laramore
Phone: 206-616-8289
Virginia Mason Medical Center
Status: Active
Contact: Craig R. Nichols
Phone: 206-342-6954 Email: vmmc.cancer_clinical_research@VirginiaMason.org
Vancouver
PeaceHealth Southwest Medical Center
Status: Active
Contact: Alison Katherine Conlin
Phone: 360-514-3940 Email: kmakin-bond@peacehealth.org

West Virginia

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

Wisconsin

La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Collin D. Driscoll
Phone: 608-775-2385 Email: cancerctr@gundersenhealth.org
Milwaukee
Froedtert and the Medical College of Wisconsin
Status: Temporarily closed to accrual
Contact: Joseph A. Bovi
Phone: 414-805-4380
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: Temporarily closed to accrual
Contact: Timothy Robert Wassenaar
Phone: 262-928-7878
Waukesha
ProHealth Waukesha Memorial Hospital
Status: Temporarily closed to accrual
Contact: Timothy Robert Wassenaar
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: Temporarily closed to accrual
Contact: Timothy Robert Wassenaar
Phone: 262-928-5539 Email: Chanda.miller@phci.org

Alberta

Calgary
Tom Baker Cancer Centre
Status: Temporarily closed to accrual
Contact: Roger Tsang
Phone: 403-521-3433

Manitoba

Winnipeg
CancerCare Manitoba
Status: Temporarily closed to accrual
Contact: Marshall W. Pitz
Phone: 866-561-1026 Email: CIO_Web@cancercare.mb.ca

Ontario

Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: Temporarily closed to accrual
Contact: Garth Andrew Nicholas
Phone: 613-761-4395
Toronto
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Status: Temporarily closed to accrual
Contact: James J. Perry
Phone: 416-480-5000
University Health Network-Princess Margaret Hospital
Status: Temporarily closed to accrual
Contact: Warren P. Mason
Phone: 416-946-4501 Email: clinical.trials@uhn.on.ca

Quebec

Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: Temporarily closed to accrual
Contact: Giuseppina Laura Masucci
Phone: 514-890-8000ext12725 Email: info.cr.chum@ssss.gouv.qc.ca
CHUM - Hopital Notre-Dame
Status: Temporarily closed to accrual
Contact: Giuseppina Laura Masucci
Phone: 514-890-8000ext23611 Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: Temporarily closed to accrual
Contact: Mussawar Iqbal
Phone: 306-766-2213

Austria

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

Belgium

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

France

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

Netherlands

Amsterdam
Vrije Universiteit Medisch Centrum
Status: Active
Contact: Kurt A. Jaeckle
Groningen
University Medical Center Groningen
Status: Active
Contact: Kurt A. Jaeckle
Maastricht
Maastro Clinic-Maastricht Radiation Oncology
Status: Active
Contact: Kurt A. Jaeckle
Phone: 904-953-7102 Email: jaeckle.kurt@mayo.edu
Rotterdam
Erasmus University Medical Center
Status: Active
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 longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT → PCV).

II. To determine whether there is a difference in survival based on (1;19)(q10,p10) translocation status and 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 biospecimens (plasma or serum, deoxyribonucleic acid [DNA] from tumor and peripheral blood mononuclear cells DNA, tumor tissue, and magnetic resonance imaging [MRI]/ computed tomography [CT] images) for future correlative scientific investigations which explore the scientific relationships of any known and yet-to-be developed markers to clinical outcome and imaging data.

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 for 5-7 weeks. 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. Treatment repeats every 6-7 weeks for up to 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 5-7 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 4 weeks 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