Radiation Therapy or Radiation Therapy and Temozolomide in Treating Patients with Newly Diagnosed Anaplastic Glioma or Low Grade Glioma
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
Status: Active
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu
Mobile
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 251-633-1890
Alaska
Anchorage
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Arizona
Phoenix
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 623-587-4868
Status: Active
Contact: Site Public Contact
Phone: 877-602-4111
Scottsdale
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-360-6371
California
Anaheim
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Auburn
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Burlingame
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Cameron Park
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Clovis
Status: Active
Contact: Site Public Contact
Phone: 559-387-1827
Status: Active
Contact: Site Public Contact
Phone: 559-256-9680
La Jolla
Status: Active
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu
Los Angeles
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Modesto
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Oakland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Status: Active
Contact: Site Public Contact
Phone: 877-827-8839
Email: ucstudy@uci.edu
Roseville
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Sacramento
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Santa Clara
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vacaville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Vallejo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Colorado
Colorado Springs
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Denver
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Lakewood
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Littleton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Longmont
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Loveland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Pueblo
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Connecticut
New Haven
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
District of Columbia
Washington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 202-243-2373
Email: jquiver1@jhmi.edu
Florida
Boca Raton
Status: Active
Contact: Site Public Contact
Phone: 561-955-4800
Jacksonville
Status: Active
Contact: Site Public Contact
Phone: 904-202-7468
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Orlando
Status: Active
Contact: Site Public Contact
Phone: 407-303-2090
Email: FH.Cancer.Research@flhosp.org
Georgia
Atlanta
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868
Status: Active
Contact: Site Public Contact
Phone: 888-946-7447
Status: Active
Contact: Site Public Contact
Phone: 404-425-7943
Email: ORS@piedmont.org
Idaho
Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Post Falls
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Illinois
Bloomington
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carthage
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Centralia
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Chicago
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Decatur
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Eureka
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Galesburg
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Macomb
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Maywood
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Ottawa
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Swansea
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Indiana
Mishawaka
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
South Bend
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-284-7370
Iowa
Ames
Status: Active
Contact: Site Public Contact
Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com
Clive
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Creston
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 515-282-2200
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 515-241-8704
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 515-282-2921
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
West Des Moines
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 515-343-1000
Kentucky
Lexington
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Status: Active
Contact: Site Public Contact
Phone: 502-629-2500
Louisiana
Marrero
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu
Maryland
Baltimore
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
Bethesda
Status: Active
Contact: Site Public Contact
Phone: 301-319-2100
Rockville
Status: Active
Contact: Kurt A. Jaeckle
Massachusetts
Boston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-726-5130
Michigan
Ann Arbor
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Grand Rapids
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Traverse City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Minnesota
Burnsville
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Coon Rapids
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Duluth
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Edina
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fridley
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Robbinsdale
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Stillwater
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Waconia
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Willmar
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Missouri
Cape Girardeau
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Columbia
Status: Active
Contact: Site Public Contact
Phone: 573-882-7440
Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Montana
Billings
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Nebraska
Grand Island
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Kearney
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Lincoln
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 402-484-4911
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 402-327-7363
Email: bronsonr@leadingcancercare.com
Omaha
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Status: Active
Contact: Gamini S. Soori
Phone: 402-991-8070ext202
Email: mwilwerding@mvcc.cc
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 402-991-0070
Email: mwilwerding@canceralliance-ne.org
Papillion
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Scottsbluff
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 402-991-0070
Email: mwilwerding@canceralliance-ne.org
Nevada
Las Vegas
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Reno
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
New Mexico
Albuquerque
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org
New York
Rochester
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 585-341-8113
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
North Carolina
Winston-Salem
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771
North Dakota
Grand Forks
Status: Active
Contact: Site Public Contact
Phone: 701-780-6520
Ohio
Cleveland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Columbus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mayfield Heights
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Sylvania
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
Westerville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Oklahoma
Oklahoma City
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu
Tulsa
Status: Active
Contact: Site Public Contact
Phone: 918-505-3200
Oregon
Clackamas
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Pennsylvania
Allentown
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bethlehem
Status: Active
Contact: Site Public Contact
Phone: 484-503-4151
Danville
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Philadelphia
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 215-955-6084
West Reading
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
South Carolina
Charleston
Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Greenville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Greer
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Spartanburg
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
South Dakota
Rapid City
Status: Active
Contact: Site Public Contact
Phone: 605-716-3982
Email: research@rcrh.org
Tennessee
Nashville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-811-8480
Texas
Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-590-5582
Email: canceranswerline@UTSouthwestern.edu
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Galveston
Status: Active
Contact: Site Public Contact
Phone: 409-772-1950
Email: clinical.research@utmb.edu
League City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-917-8906
Utah
Cedar City
Status: Active
Contact: Site Public Contact
Phone: 435-868-5680
Email: officeofresearch@imail.org
Murray
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Provo
Status: Active
Contact: Site Public Contact
Phone: 801-357-7965
Email: officeofresearch@imail.org
Saint George
Status: Active
Contact: Site Public Contact
Phone: 435-688-4167
Email: officeofresearch@imail.org
Salt Lake City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 801-408-1347
Email: officeofresearch@imail.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 801-933-6070
Email: officeofresearch@imail.org
Virginia
Richmond
Status: Active
Contact: Site Public Contact
Phone: 804-628-1914
Email: klcampbell@vcu.edu
Washington
Bellingham
Status: Active
Contact: Site Public Contact
Phone: 360-715-4133
Email: mjohnson9@peacehealth.org
Kennewick
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-783-4637
Email: research@kadlecmed.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-377-0856
Mount Vernon
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-814-2687
Email: rcccclinicalresearch@skagitvalleyhospital.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-814-2146
Email: rcccclinicalresearch@skagitvalleyhospital.org
Seattle
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-804-8824
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-804-8824
Status: Active
Contact: Site Public Contact
Phone: 800-804-8824
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org
Vancouver
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-514-3940
Email: kmakin-bond@peacehealth.org
West Virginia
Morgantown
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu
Wisconsin
Ashland
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
La Crosse
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Milwaukee
Status: Active
Contact: Site Public Contact
Phone: 414-805-3666
Oconomowoc
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 262-928-7878
Waukesha
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 262-928-7632
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 262-928-5539
Email: Chanda.miller@phci.org
Alberta
Calgary
Status: Active
Contact: Site Public Contact
Phone: 403-521-3433
British Columbia
Vancouver
Status: Active
Contact: Site Public Contact
Phone: 888-939-3333
Manitoba
Winnipeg
Status: Active
Contact: Site Public Contact
Phone: 866-561-1026
Email: ctu_web@cancercare.mb.ca
Ontario
Ottawa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 613-761-4395
Toronto
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 416-480-5000
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 416-946-4501
Email: clinical.trials@uhn.on.ca
Quebec
Montreal
Status: Active
Contact: Site Public Contact
Phone: 514-890-8000ext12725
Email: info.cr.chum@ssss.gouv.qc.ca
Status: Temporarily closed to accrual
Contact: Giuseppina Laura Masucci
Phone: 514-890-8000ext23611
Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca
Saskatchewan
Regina
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 306-766-2213
Austria
Vienna
Status: Active
Contact: Kurt A. Jaeckle
Belgium
Antwerpen
Status: Active
Contact: Kurt A. Jaeckle
Phone: 904-953-7102
Email: jaeckle.kurt@mayo.edu
France
Lyon
Status: Active
Contact: Kurt A. Jaeckle
Nice
Status: Active
Contact: Kurt A. Jaeckle
Phone: 904-953-7102
Email: jaeckle.kurt@mayo.edu
Villejuif
Status: Active
Contact: Kurt A. Jaeckle
Netherlands
Amsterdam
Status: Active
Contact: Kurt A. Jaeckle
Groningen
Status: Active
Contact: Kurt A. Jaeckle
Maastricht
Status: Active
Contact: Kurt A. Jaeckle
Phone: 904-953-7102
Email: jaeckle.kurt@mayo.edu
Rotterdam
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, including comparisons between photon and proton radiotherapy.
IV. To determine the toxicity of the treatment in each arm and perform descriptive comparisons as well as comparisons between photon and proton radiotherapy.
V. To determine the neurocognitive and quality of life (QOL) effects in patients treated on this protocol and correlate these results with outcome endpoints as well as comparisons between photon and proton radiotherapy.
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
Treatment
Lead Organization
Lead Organization
Alliance for Clinical Trials in Oncology
Principal Investigator
Kurt A. Jaeckle
Trial IDs
Secondary IDs NCI-2011-01915, CDR0000640442, EORTC-26081-22086, EudraCT-2008-007295-14, NCCTG-N0577
Clinicaltrials.gov ID NCT00887146