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Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

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ClinicalTrials.gov Identifier: NCT00887146
Recruitment Status : Recruiting
First Posted : April 23, 2009
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
European Organisation for Research and Treatment Center (EORTC)
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: concomitant temozolomide (TMZ) Radiation: radiotherapy Drug: procarbazine Drug: adjuvant temozolomide (TMZ) Drug: CCNU Drug: vincristine Phase 3

Detailed Description:

This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with 1p/19q co-deletion. This study includes two arms as described in the "Arms" section. A dynamic allocation procedure will be used to allocate an equal number of patients to different arms (Arms A:B = 1:1). This procedure will balance the marginal distributions of the stratification factors among arms. The stratification factors that will be used are cooperative groups (EORTC vs. all North American groups), age (≤ 50 vs. > 50), performance score (ECOG 0-1 vs. 2), and tumor grade (anaplastic glioma vs. low grade glioma).

The primary goal is to determine whether patients who receive radiotherapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --> TMZ) (Arm B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by PCV chemotherapy (RT --> PCV)(Arm A).

Secondary Goals:

  1. Time to Progression - To determine whether patients who receive (RT + TMZ --> TMZ) have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT --> PCV).
  2. Correlation between exploratory biomarkers and survival - To determine whether there is a difference in survival based on t(1;19)(q10, p10) translocation status and MGMT promoter hypermethylation status.
  3. Descriptive Comparisons of Additional Secondary Endpoints - To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life.
  4. Toxicity - To determine the toxicity of the treatment in each arm and perform descriptive comparisons.
  5. Neurocognitive and Quality of Life (QOL) Effects - To determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints.
  6. Banking of Biospecimens and Neuroimaging Studies - To store blood products (i.e., plasma, DNA and buffy coat), tumor tissue and MRI/CT images for future scientific investigations.

After completion of study treatment, patients are followed every 12 weeks for 1 year, then every 4 months for 2 years and then every 6 months until progressive disease or until the end of study participation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
Study Start Date : September 2009
Estimated Primary Completion Date : December 2018


Arm Intervention/treatment
Experimental: Arm A (RT, procarbazine, lomustine, vincristine)
Patients undergo 3D-CRT or IMRT on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride PO on days 8-21, lomustine PO on day 1 and vincristine sulfate 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.
Radiation: radiotherapy
Drug: procarbazine
Days 8-21: 60 mg/m^2 orally

Drug: CCNU
Day 1: 110 mg/m^2 orally

Drug: vincristine
Days 8 and 29: 1.4 mg/m^2 IV

Experimental: Arm B (RT, temozolomide)
Patients undergo RT as in arm I and receive temozolomide PO QD on days 1-5 for 5-7 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide PO QD days 1-5. Treatment with adjuvant temozolomide repeats every 4 weeks for 6-12 courses in the absence of disease progression and unacceptable toxicity.
Drug: concomitant temozolomide (TMZ)
75 mg/m^2, orally daily

Radiation: radiotherapy
Drug: adjuvant temozolomide (TMZ)
150 or 200 mg/m^2 orally




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Time from study registration to time of tumor progression or death due to any cause, whichever comes first, assessed up to 16 years ]
    The distribution of progression free survival for Arms A and B will be estimated using the Kaplan-Meier method. The hazard ratios and median progression free survival (PFS) will be estimated with their confidence intervals. The Cox proportional hazards model will be used to assess whether the distributions of progression survival times differ with respect to treatment regimen having adjusted for all stratification factors (cooperative groups, age, and performance score). Both non-inferiority and superiority will be tested in this trial for the primary goal and no multiple-comparison adjustment will be considered.


Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Time from study registration to the earliest evidence of clinical progression, radiographic progression or neurocognitive progression, assessed up to 16 years ]
    Estimated by Kaplan-Meier method and analyzed by Cox regression model adjusting all stratification factors. Correlations among baseline neurocognitive test scores and progression free survival will be analyzed using Cox proportional hazards model.

  2. Time to neurocognitive progression, assessed using the Hopkins Verbal Learning Test-Revised for Free Recall, Delayed Recall, and Delayed Recognition; the Controlled Oral Word Association test; and the Trail Making Test Part A or B [ Time Frame: Time from study registration to the first cognitive failure, assessed up to 16 years ]
    Estimated by Kaplan-Meier method and analyzed by Cox regression model adjusting all stratification factors. For each test in the battery, a standard error of measurement will be used to derive the Reliable Change Index (RCI) which will be used to represent the 90% confidence interval for the difference in raw scores from baseline to follow-up assessment will be coded as 1 (deterioration), 2 (no change), and 3 (improved) according to the RCI.

  3. Overall survival [ Time Frame: Time from study registration to time of death due to any cause, assessed up to 16 years ]
    The Cox proportional hazards model will be used to assess whether the distributions of overall survival times differ with respect to treatment regimen having adjusted for all stratification factors (cooperative groups, age, and Performance Score). The distribution of overall survival for Arm A and B will be estimated using the Kaplan-Meier method. The hazard ratios and median survivals will be estimated with their 95% confidence intervals.

  4. Objective tumor response defined as a complete response or partial response [ Time Frame: Up to 16 years ]
    Summarized for each arm and compared between the arms using the Chi square test.

  5. Treatment-related adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 16 years ]
    The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. Adverse events and treatment-related adverse events will be evaluated using all patients. Treatment-related adverse events will be tabulated for each arm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Registration 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887146


Contacts
Contact: Kurt Jaeckle, MD 904-953-7102

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: John B. Fiveash    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: John B. Fiveash         
Providence Hospital Suspended
Mobile, Alabama, United States, 36608
United States, Alaska
Anchorage Associates in Radiation Medicine Recruiting
Anchorage, Alaska, United States, 98508
Contact: Alison K. Conlin    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Alaska Oncology and Hematology LLC Recruiting
Anchorage, Alaska, United States, 99508
Contact: Alison K. Conlin    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Alaska Women's Cancer Care Recruiting
Anchorage, Alaska, United States, 99508
Contact: Alison K. Conlin    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: Alison K. Conlin         
Anchorage Oncology Centre Recruiting
Anchorage, Alaska, United States, 99508
Contact: Alison K. Conlin    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Katmai Oncology Group Recruiting
Anchorage, Alaska, United States, 99508
Contact: Alison K. Conlin    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Alison K. Conlin    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Alison K. Conlin         
United States, Arizona
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: David G. Brachman    888-823-5923    ctsucontact@westat.com   
Principal Investigator: David G. Brachman         
Arizona Oncology-Deer Valley Center Suspended
Phoenix, Arizona, United States, 85027
Arizona Oncology Services Foundation Suspended
Scottsdale, Arizona, United States, 85260
United States, California
Kaiser Permanente-Anaheim Recruiting
Anaheim, California, United States, 92807
Contact: Michael R. Girvigian    626-564-3455      
Principal Investigator: Michael R. Girvigian         
Sutter Cancer Centers Radiation Oncology Services-Auburn Recruiting
Auburn, California, United States, 95603
Contact: Stacy D. D'Andre    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Stacy D. D'Andre         
Mills-Peninsula Medical Center Recruiting
Burlingame, California, United States, 94010
Contact: Stacy D. D'Andre    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Stacy D. D'Andre         
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Recruiting
Cameron Park, California, United States, 95682
Contact: Stacy D. D'Andre    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Stacy D. D'Andre         
University Oncology Associates Recruiting
Fresno, California, United States, 93701
Contact: Uzair B. Chaudhary    559-256-9680      
Principal Investigator: Uzair B. Chaudhary         
California Cancer Center - North Fresno Recruiting
Fresno, California, United States, 93720
Contact: Uzair B. Chaudhary    559-447-4050      
Principal Investigator: Uzair B. Chaudhary         
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: David E. Piccioni    858-822-5354    cancercto@ucsd.edu   
Principal Investigator: David E. Piccioni         
Kaiser Permanente Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact: Michael R. Girvigian    626-564-3455      
Principal Investigator: Michael R. Girvigian         
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Jethro L. Hu    310-423-8965      
Principal Investigator: Jethro L. Hu         
Memorial Medical Center Recruiting
Modesto, California, United States, 95355
Contact: Stacy D. D'Andre    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Stacy D. D'Andre         
Kaiser Permanente Oakland-Broadway Suspended
Oakland, California, United States, 94611
Sutter Cancer Centers Radiation Oncology Services-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Stacy D. D'Andre    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Stacy D. D'Andre         
Sutter Medical Center Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Stacy D. D'Andre    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Stacy D. D'Andre         
Kaiser Permanente Medical Center - Santa Clara Suspended
Santa Clara, California, United States, 95051
Kaiser Permanente-South San Francisco Suspended
South San Francisco, California, United States, 94080
Sutter Cancer Centers Radiation Oncology Services-Vacaville Recruiting
Vacaville, California, United States, 95687
Contact: Stacy D. D'Andre    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Stacy D. D'Andre         
Sutter Solano Medical Center/Cancer Center Recruiting
Vallejo, California, United States, 94589
Contact: Stacy D. D'Andre    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Stacy D. D'Andre         
United States, Colorado
The Medical Center of Aurora Active, not recruiting
Aurora, Colorado, United States, 80012
University of Colorado Hospital Active, not recruiting
Aurora, Colorado, United States, 80045
Penrose-Saint Francis Healthcare Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Mehmet S. Copur    303-777-2663    kgeisen@co-cancerresearch.org   
Principal Investigator: Mehmet S. Copur         
UCHealth Memorial Hospital Central Active, not recruiting
Colorado Springs, Colorado, United States, 80909
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Mehmet S. Copur    303-777-2663    kgeisen@co-cancerresearch.org   
Principal Investigator: Mehmet S. Copur         
Saint Anthony Hospital Recruiting
Lakewood, Colorado, United States, 80228
Contact: Mehmet S. Copur    303-777-2663    kgeisen@co-cancerresearch.org   
Principal Investigator: Mehmet S. Copur         
Littleton Adventist Hospital Recruiting
Littleton, Colorado, United States, 80122
Contact: Mehmet S. Copur    303-777-2663    kgeisen@co-cancerresearch.org   
Principal Investigator: Mehmet S. Copur         
Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Mehmet S. Copur    303-777-2663    kgeisen@co-cancerresearch.org   
Principal Investigator: Mehmet S. Copur         
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Keren Sturtz    303-777-2663    ccrp@co-cancerresearch.org   
Principal Investigator: Keren Sturtz         
Saint Mary Corwin Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Mehmet S. Copur    303-777-2663    kgeisen@co-cancerresearch.org   
Principal Investigator: Mehmet S. Copur         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Kevin P. Becker    203-785-5702      
Principal Investigator: Kevin P. Becker         
United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Matthias Holdhoff    202-243-2373    jquiver1@jhmi.edu   
Principal Investigator: Matthias Holdhoff         
United States, Florida
Boca Raton Regional Hospital Recruiting
Boca Raton, Florida, United States, 33486
Contact: Sajeel A. Chowdhary    561-955-4800      
Principal Investigator: Sajeel A. Chowdhary         
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: David D. Tran    888-823-5923    ctsucontact@westat.com   
Principal Investigator: David D. Tran         
Baptist MD Anderson Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
Contact: Robert Cavaliere    904-202-7051      
Principal Investigator: Robert Cavaliere         
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Paul D. Brown    855-776-0015      
Principal Investigator: Paul D. Brown         
Florida Hospital Orlando Active, not recruiting
Orlando, Florida, United States, 32803
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Alfredo D. Voloschin    888-946-7447      
Principal Investigator: Alfredo D. Voloschin         
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Adam W. Nowlan    404-425-7943    ORS@piedmont.org   
Principal Investigator: Adam W. Nowlan         
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Alfredo D. Voloschin    404-778-1868      
Principal Investigator: Alfredo D. Voloschin         
United States, Idaho
Kootenai Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
United States, Illinois
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: Bryan A. Faller    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Northwestern University Suspended
Chicago, Illinois, United States, 60611
University of Chicago Comprehensive Cancer Center Suspended
Chicago, Illinois, United States, 60637
Cancer Care Specialists of Central Illinois Recruiting
Decatur, Illinois, United States, 62526
Contact: Bryan A. Faller    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Bryan A. Faller    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Bryan A. Faller    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Western Illinois Cancer Treatment Center Recruiting
Galesburg, Illinois, United States, 61401
Contact: Bryan A. Faller    309-344-2831      
Principal Investigator: Bryan A. Faller         
AMITA Health Adventist Medical Center Active, not recruiting
La Grange, Illinois, United States, 60525
Loyola University Medical Center Suspended
Maywood, Illinois, United States, 60153
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Bryan A. Faller    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Advocate Lutheran General Hospital Active, not recruiting
Park Ridge, Illinois, United States, 60068
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Recruiting
Pekin, Illinois, United States, 61554
Contact: Bryan A. Faller    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Bryan A. Faller    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Recruiting
Peoria, Illinois, United States, 61615
Contact: Bryan A. Faller    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Bryan A. Faller    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Bryan A. Faller    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Bryan A. Faller    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Valley Radiation Oncology Recruiting
Peru, Illinois, United States, 61354
Contact: Bryan A. Faller    815-664-4141      
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Bryan A. Faller    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Cancer Care Specialists of Illinois-Swansea Recruiting
Swansea, Illinois, United States, 62226
Contact: Bryan A. Faller    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
United States, Indiana
Parkview Hospital Randallia Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang    260-373-8888    parkviewresearch@parkview.com   
Principal Investigator: Brian K. Chang         
Memorial Regional Cancer Center Day Road Recruiting
Mishawaka, Indiana, United States, 46545
Contact: Thomas J. Reid    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: Thomas J. Reid         
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Thomas J. Reid    800-284-7370      
Principal Investigator: Thomas J. Reid         
United States, Iowa
McFarland Clinic PC - Ames Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
Medical Oncology and Hematology Associates-West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Mehmet S. Copur    515-247-3970      
Principal Investigator: Mehmet S. Copur         
Mercy Cancer Center-West Lakes Recruiting
Clive, Iowa, United States, 50325
Contact: Mehmet S. Copur    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Mehmet S. Copur         
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    515-241-6727      
Principal Investigator: Robert J. Behrens         
Iowa-Wide Oncology Research Coalition NCORP Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    515-282-2921      
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Des Moines Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    515-282-2921      
Principal Investigator: Robert J. Behrens         
Broadlawns Medical Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Laurel Recruiting
Des Moines, Iowa, United States, 50314
Contact: Mehmet S. Copur    515-247-3970      
Principal Investigator: Mehmet S. Copur         
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Mehmet S. Copur    888-221-4849      
Principal Investigator: Mehmet S. Copur         
Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Robert J. Behrens    515-241-8704      
Principal Investigator: Robert J. Behrens         
Methodist West Hospital Recruiting
West Des Moines, Iowa, United States, 50266-7700
Contact: Robert J. Behrens    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: Robert J. Behrens         
Mercy Medical Center-West Lakes Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Mehmet S. Copur    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Mehmet S. Copur         
United States, Kansas
Kansas City NCI Community Oncology Research Program Terminated
Prairie Village, Kansas, United States, 66208
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: John L. Villano    859-257-3379      
Principal Investigator: John L. Villano         
Norton Hospital Pavilion and Medical Campus Recruiting
Louisville, Kentucky, United States, 40202
Contact: Aaron C. Spalding    502-629-2500      
Principal Investigator: Aaron C. Spalding         
United States, Maine
Maine Medical Center-Bramhall Campus Active, not recruiting
Portland, Maine, United States, 04102
Maine Medical Center- Scarborough Campus Active, not recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Matthias Holdhoff    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Matthias Holdhoff         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Brett J. Theeler    301-319-2100      
Principal Investigator: Brett J. Theeler         
Cancer Trials Support Unit Recruiting
Rockville, Maryland, United States, 20850-2062
Contact: Kurt A. Jaeckle         
Principal Investigator: Kurt A. Jaeckle         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Suspended
Boston, Massachusetts, United States, 02114
United States, Michigan
Bixby Medical Center Active, not recruiting
Adrian, Michigan, United States, 49221
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Michelle M. Kim    800-865-1125      
Principal Investigator: Michelle M. Kim         
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
Mercy Health Saint Mary's Active, not recruiting
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus Active, not recruiting
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Sunil Nagpal    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Sunil Nagpal         
William Beaumont Hospital-Royal Oak Active, not recruiting
Royal Oak, Michigan, United States, 48073
Munson Medical Center Active, not recruiting
Traverse City, Michigan, United States, 49684
William Beaumont Hospital - Troy Active, not recruiting
Troy, Michigan, United States, 48098
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Essentia Health Cancer Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret E. Friday    218-786-3308      
Principal Investigator: Bret E. Friday         
Miller-Dwan Hospital Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret E. Friday    888-203-7267      
Principal Investigator: Bret E. Friday         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Daniel M. Anderson    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: Daniel M. Anderson         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Paul D. Brown    855-776-0015      
Principal Investigator: Paul D. Brown         
Metro Minnesota Community Oncology Research Consortium Terminated
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
Minnesota Oncology Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Daniel M. Anderson    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Daniel M. Anderson         
United States, Missouri
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Bryan A. Faller    573-334-2230    sfmc@sfmc.net   
Principal Investigator: Bryan A. Faller         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jian L. Campian    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Jian L. Campian         
United States, Montana
Billings Clinic Cancer Center Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-996-2663    research@billingsclinic.org   
Principal Investigator: Benjamin T. Marchello         
Saint Vincent Healthcare Suspended
Billings, Montana, United States, 59101
United States, Nebraska
CHI Health Saint Francis Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Mehmet S. Copur    800-998-2119      
Principal Investigator: Mehmet S. Copur         
CHI Health Good Samaritan Recruiting
Kearney, Nebraska, United States, 68847
Contact: Mehmet S. Copur    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Mehmet S. Copur         
Nebraska Hematology and Oncology Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Gamini S. Soori    402-484-4911      
Principal Investigator: Gamini S. Soori         
Southeast Nebraska Cancer Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Gamini S. Soori    402-327-7363      
Principal Investigator: Gamini S. Soori         
Missouri Valley Cancer Consortium Recruiting
Omaha, Nebraska, United States, 68106
Contact: Gamini S. Soori    402-991-8070 ext 202    mwilwerding@mvcc.cc   
Principal Investigator: Gamini S. Soori         
Alegent Health Immanuel Medical Center Recruiting
Omaha, Nebraska, United States, 68122
Contact: Mehmet S. Copur    402-343-8511    research@alegent.org   
Principal Investigator: Mehmet S. Copur         
Alegent Health Bergan Mercy Medical Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Mehmet S. Copur    402-398-6060      
Principal Investigator: Mehmet S. Copur         
Nebraska Cancer Specialists - Omaha Recruiting
Omaha, Nebraska, United States, 68124
Contact: Gamini S. Soori    402-393-3110      
Principal Investigator: Gamini S. Soori         
Alegent Health Lakeside Hospital Recruiting
Omaha, Nebraska, United States, 68130
Contact: Mehmet S. Copur    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Mehmet S. Copur         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Nicole A. Shonka    402-559-6941    unmcrsa@unmc.edu   
Principal Investigator: Nicole A. Shonka         
Midlands Community Hospital Suspended
Papillion, Nebraska, United States, 68046
Regional West Medical Center Cancer Center Recruiting
Scottsbluff, Nebraska, United States, 69361
Contact: Gamini S. Soori    308-630-2429      
Principal Investigator: Gamini S. Soori         
United States, Nevada
Radiation Oncology Centers of Nevada Central Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
21st Century Oncology Recruiting
Las Vegas, Nevada, United States, 89109
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Saint Mary's Regional Medical Center Recruiting
Reno, Nevada, United States, 89503
Contact: John A. Ellerton    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: John A. Ellerton         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08903
Rutgers Cancer Institute of New Jersey Active, not recruiting
New Brunswick, New Jersey, United States, 08903
Overlook Hospital Suspended
Summit, New Jersey, United States, 07902
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Olivier Rixe    505-925-0366    LByatt@nmcca.org   
Principal Investigator: Olivier Rixe         
United States, New York
New York-Presbyterian/Brooklyn Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Sameer Rafla-Demetrious    718-780-3677    Adg9003@nyp.org   
Principal Investigator: Sameer Rafla-Demetrious         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Andrew B. Lassman    212-305-8615      
Principal Investigator: Andrew B. Lassman         
Highland Hospital Recruiting
Rochester, New York, United States, 14620
Contact: Yuhchyau Chen    585-341-8113      
Principal Investigator: Yuhchyau Chen         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen    585-275-5830      
Principal Investigator: Yuhchyau Chen         
State University of New York Upstate Medical University Suspended
Syracuse, New York, United States, 13210
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Glenn J. Lesser    336-713-6771      
Principal Investigator: Glenn J. Lesser         
United States, North Dakota
Altru Cancer Center Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Grant R. Seeger    701-780-6520      
Principal Investigator: Grant R. Seeger         
United States, Ohio
Case Western Reserve University Active, not recruiting
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44109
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Samuel T. Chao    866-223-8100      
Principal Investigator: Samuel T. Chao         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Vinay K. Puduvalli    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: Vinay K. Puduvalli         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Timothy D. Moore    614-566-4475      
Principal Investigator: Timothy D. Moore         
Columbus NCI Community Oncology Research Program Terminated
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: Timothy D. Moore    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: Timothy D. Moore         
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: Timothy D. Moore    614-234-5433      
Principal Investigator: Timothy D. Moore         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Samuel T. Chao    440-312-4293    hugneyc@cchseast.org   
Principal Investigator: Samuel T. Chao         
Flower Hospital Recruiting
Sylvania, Ohio, United States, 43560
Contact: Abhijit B. Saste    419-824-1842      
Principal Investigator: Abhijit B. Saste         
Saint Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: Timothy D. Moore    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: Timothy D. Moore         
Cleveland Clinic Wooster Family Health and Surgery Center Recruiting
Wooster, Ohio, United States, 44691
Contact: Samuel T. Chao    800-862-7798      
Principal Investigator: Samuel T. Chao         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Terence S. Herman         
Oklahoma Cancer Specialists and Research Institute-Tulsa Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Terence S. Herman    918-505-3200      
Principal Investigator: Terence S. Herman         
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Alison K. Conlin    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Alison K. Conlin         
Legacy Mount Hood Medical Center Active, not recruiting
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital and Medical Center Active, not recruiting
Portland, Oregon, United States, 97210
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Alison K. Conlin    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Alison K. Conlin         
Providence Saint Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Alison K. Conlin    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Alison K. Conlin         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Willard G. Andrews    215-481-2402      
Principal Investigator: Willard G. Andrews         
Lehigh Valley Hospital-Cedar Crest Suspended
Allentown, Pennsylvania, United States, 18103
Saint Luke's University Hospital-Bethlehem Campus Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Hugh D. Moulding    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Hugh D. Moulding         
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Na Tosha N. Gatson    570-271-5251      
Principal Investigator: Na Tosha N. Gatson         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jon Glass    215-955-6084      
Principal Investigator: Jon Glass         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Aruna Padmanabhan    215-728-2983      
Principal Investigator: Aruna Padmanabhan         
University of Pittsburgh Cancer Institute (UPCI) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: David A. Clump    412-647-8073      
Principal Investigator: David A. Clump         
Geisinger Wyoming Valley/Henry Cancer Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Na Tosha N. Gatson    570-271-5251      
Principal Investigator: Na Tosha N. Gatson         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Scott M. Lindhorst    843-792-9321      
Principal Investigator: Scott M. Lindhorst         
Greenville Health System Cancer Institute-Andrews Suspended
Greenville, South Carolina, United States, 29601
Greenville Health System Cancer Institute-Butternut Suspended
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: David L. Grisell    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: David L. Grisell    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: David L. Grisell    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: David L. Grisell    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: David L. Grisell         
Spartanburg Medical Center Active, not recruiting
Spartanburg, South Carolina, United States, 29303
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: David L. Grisell    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: David L. Grisell         
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Kathryn A. Arrambide    605-716-3982    research@rcrh.org   
Principal Investigator: Kathryn A. Arrambide         
United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Paul L. Moots    800-811-8480      
Principal Investigator: Paul L. Moots         
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Edward Pan    214-648-7097      
Principal Investigator: Edward Pan         
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0565
Contact: Todd A. Swanson    409-772-1950    clinical.research@utmb.edu   
Principal Investigator: Todd A. Swanson         
UTMB Cancer Center at Victory Lakes Recruiting
League City, Texas, United States, 77573
Contact: Todd A. Swanson    800-917-8906      
Principal Investigator: Todd A. Swanson         
United States, Utah
Sandra L Maxwell Cancer Center Recruiting
Cedar City, Utah, United States, 84720
Contact: Gordon A. Watson    435-868-5680      
Principal Investigator: Gordon A. Watson         
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Gordon A. Watson    801-507-3950      
Principal Investigator: Gordon A. Watson         
Utah Valley Regional Medical Center Recruiting
Provo, Utah, United States, 84604
Contact: Gordon A. Watson    801-357-7965      
Principal Investigator: Gordon A. Watson         
Dixie Medical Center Regional Cancer Center Recruiting
Saint George, Utah, United States, 84770
Contact: Gordon A. Watson    435-688-4167      
Principal Investigator: Gordon A. Watson         
Utah Cancer Specialists-Salt Lake City Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Gordon A. Watson    801-933-6070    research@utahcancer.com   
Principal Investigator: Gordon A. Watson         
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Adam L. Cohen    801-581-4477    clinical.trials@hci.utah.edu   
Principal Investigator: Adam L. Cohen         
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Gordon A. Watson    801-408-1347      
Principal Investigator: Gordon A. Watson         
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Mark G. Malkin    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: Mark G. Malkin         
United States, Washington
PeaceHealth Saint Joseph Medical Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Alison K. Conlin    360-715-4133    cpatz@peacehealth.org   
Principal Investigator: Alison K. Conlin         
Kadlec Clinic Hematology and Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact: Alison K. Conlin    509-783-4637    research@cbho.org   
Principal Investigator: Alison K. Conlin         
Tri-Cities Cancer Center Suspended
Kennewick, Washington, United States, 99336
Skagit Valley Hospital Regional Cancer Care Center Suspended
Mount Vernon, Washington, United States, 98273
Skagit Valley Hospital Suspended
Mount Vernon, Washington, United States, 98274
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Craig R. Nichols    206-342-6954    vmmc.cancer_clinical_research@VirginiaMason.org   
Principal Investigator: Craig R. Nichols         
Fred Hutchinson Cancer Research Center Suspended
Seattle, Washington, United States, 98109
Seattle Cancer Care Alliance Suspended
Seattle, Washington, United States, 98109
University of Washington Medical Center Suspended
Seattle, Washington, United States, 98195
PeaceHealth Southwest Medical Center Recruiting
Vancouver, Washington, United States, 98664
Contact: Alison K. Conlin    360-514-3940    kmakin-bond@peacehealth.org   
Principal Investigator: Alison K. Conlin         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Aaron P. Provenzano    304-293-7374    cancertrialsinfo@hsc.wvu.edu   
Principal Investigator: Aaron P. Provenzano         
United States, Wisconsin
Gundersen Lutheran Medical Center Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Collin D. Driscoll    608-775-2385    cancerctr@gundersenhealth.org   
Principal Investigator: Collin D. Driscoll         
Aurora Saint Luke's Medical Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Joseph A. Bovi    414-805-4380      
Principal Investigator: Joseph A. Bovi         
ProHealth Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Contact: Timothy R. Wassenaar    262-928-7878      
Principal Investigator: Timothy R. Wassenaar         
ProHealth Waukesha Memorial Hospital Suspended
Waukesha, Wisconsin, United States, 53188
UW Cancer Center at ProHealth Care Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Timothy R. Wassenaar    262-928-5539    Chanda.miller@phci.org   
Principal Investigator: Timothy R. Wassenaar         
Austria
Medical University Vienna Recruiting
Vienna, Austria, A-1090
Contact: Kurt A. Jaeckle         
Principal Investigator: Kurt A. Jaeckle         
Belgium
Alegemeen Ziekenhuis Middelheim Recruiting
Antwerpen, Belgium, 2020
Contact: Kurt A. Jaeckle    904-953-7102    jaeckle.kurt@mayo.edu   
Principal Investigator: Kurt A. Jaeckle         
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Roger Tsang    403-521-3433      
Principal Investigator: Roger Tsang         
Cross Cancer Institute Active, not recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
CancerCare Manitoba Suspended
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
London Regional Cancer Program Active, not recruiting
London, Ontario, Canada, N6A 4L6
Ottawa Hospital and Cancer Center-General Campus Suspended
Ottawa, Ontario, Canada, K1H 8L6
Odette Cancer Centre- Sunnybrook Health Sciences Centre Suspended
Toronto, Ontario, Canada, M4N 3M5
University Health Network-Princess Margaret Hospital Suspended
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM - Hopital Notre-Dame Suspended
Montreal, Quebec, Canada, H2L 4M1
CHUM - Centre Hospitalier de l'Universite de Montreal Suspended
Montreal, Quebec, Canada, H2X 3E4
Canada, Saskatchewan
Allan Blair Cancer Centre Suspended
Regina, Saskatchewan, Canada, S4T 7T1
France
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Kurt A. Jaeckle         
Principal Investigator: Kurt A. Jaeckle         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Kurt A. Jaeckle    904-953-7102    jaeckle.kurt@mayo.edu   
Principal Investigator: Kurt A. Jaeckle         
Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Kurt A. Jaeckle         
Principal Investigator: Kurt A. Jaeckle         
Netherlands
Academ Zienkenhuis Bij De University Recruiting
Amsterdam, Netherlands, 1007 MB
Contact: Kurt A. Jaeckle         
Principal Investigator: Kurt A. Jaeckle         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 GZ
Contact: Kurt A. Jaeckle         
Principal Investigator: Kurt A. Jaeckle         
Maastro Clinic-Maastricht Radiation Oncology Recruiting
Maastricht, Netherlands, 6229 NA
Contact: Kurt A. Jaeckle    904-953-7102    jaeckle.kurt@mayo.edu   
Principal Investigator: Kurt A. Jaeckle         
Erasmus University Medical Center Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Kurt A. Jaeckle         
Principal Investigator: Kurt A. Jaeckle         
Switzerland
University Hospital Zurich Not yet recruiting
Zürich, Switzerland, CH 8091
Contact: Michael Weller, MD         
Principal Investigator: Michael Michael, MD         
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
European Organisation for Research and Treatment Center (EORTC)
NCIC Clinical Trials Group
Investigators
Study Chair: Kurt Jaeckle, MD Mayo Clinic

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00887146     History of Changes
Other Study ID Numbers: N0577
NCI-2011-01915 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
EORTC-26081-22086
EudraCT-2008-007295-14
CDR0000640442 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Keywords provided by Alliance for Clinical Trials in Oncology:
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Temozolomide
Dacarbazine
Vincristine
Procarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators