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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

Radiation Therapy With Concomitant and Adjuvant Temozolomide or Radiation Therapy With Adjuvant PCV or Temozolomide Alone in Treating Patients With Anaplastic Glioma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Tissue collection/Repository, TreatmentActive18 and overNCI, OtherNCCTG-N0577
NCI-2011-01915, EORTC-26081-22086, EudraCT-2008-007295-14, CDR0000640442, N0577, NCT00887146

Trial Description

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 temozolomide alone, radiation followed by PCV, or temozolomide together with radiation therapy followed by temozolomide is more effective in treating anaplastic glioma.

Further Study Information

This research study is a Phase III clinical trial. The purpose of this study is to compare the effectiveness of radiotherapy with temozolomide followed by temozolomide chemotherapy versus radiotherapy followed by PCV chemotherapy versus temozolomide chemotherapy alone in the treatment of anaplastic glioma. Patients are stratified according to cooperative group (EORTC vs North American groups [NCCTG, RTOG, CTSU, and NCIC CTG]), age (≤ 50 years vs > 50 years), and ECOG performance score (0 or 1 vs 2). Patients are randomized to 1 of 3 treatment arms. Please see the "Arms" section below for more detailed information. The primary and secondary objectives are summarized below.

Objectives:

Primary Objective:

To determine whether patients who receive radiotherapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --> TMZ) have a marginally better progression free survival (PFS) than patients who receive radiotherapy followed by PCV chemotherapy (RT --> PCV).

Secondary Objectives:

1. Time to Progression - To determine whether patients who receive temozolomide (TMZ) alone have a significantly longer time to progression (neurocognitive, clinical or radiographic progression) than patients who receive radiotherapy with concomitant TMZ followed by adjuvant TMZ (RT + TMZ --> TMZ) or radiotherapy followed by PCV chemotherapy (RT --> PCV).

2. Survival Difference - Determine whether there is a difference in survival based on translocation status and MGMT promoter hypermethylation status.

3. Descriptive Comparisons of Additional Secondary Endpoints - Perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life.

4. Toxicity - Determine the toxicity of the treatment in each arm and perform descriptive comparisons.

5. Descriptive Determination of Timing of RT - Determine descriptively whether it is reasonable to delay RT in this patient cohort by documenting the time to progression and progression free survival of patients receiving temozolomide alone

6. Neurocognitive and Quality of Life (QOL) Effects - Determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints

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

Eligibility Criteria

Pre-Registration Inclusion Criteria:

Central Pathology Review Submission This review is mandatory prior to registration to confirm eligibility. Patients must be willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. It should be initiated as soon after surgery as possible.

Registration Inclusion Criteria:

1. Age ≥ 18 years

2. Newly diagnosed and ≤ 3 months from surgical diagnosis

3. Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade III], as determined by pre-registration central pathology review. Note: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q.

4. Tumor is co-deleted for 1p and 19q.

5. Surgery (partial or gross total resection or biopsy) must be performed ≥ 2 weeks prior to registration. Patient must have recovered from the effects of surgery.

6. The following laboratory values obtained ≤ 21 days prior to registration.

1. Absolute neutrophil count (ANC) ≥ 1500/mm3

2. Platelet (PLTs) count ≥ 100,000/mm3

3. Hemoglobin (Hgb) > 9.0g/dL

4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

5. Serum glutamic oxaloacetic transaminase (SGOT) aspartate transaminase (AST) ≤ 3 x ULN

6. Creatinine ≤ 1.5 x ULN

7. Negative serum or urine pregnancy test done ≤ 7 days prior to registration for women of childbearing potential only.

8. Willing and able to complete neurocognitive testing without assistance and the Quality of Life (QOL) questionnaires with or without assistance

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

10. Provide informed written consent.

11. Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (ie, active treatment and observation portion of the study)

12. Mandatory Tissue Samples for Correlative Research - Patient is willing to provide tissue samples for correlative research purposes

Registration Exclusion Criteria:

1. Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of temozolomide treatments.

2. Received any prior surgery, radiation therapy or chemotherapy for any central nervous system (CNS) neoplasm. Note: Patients who have had a prior low grade glioma with or without surgery and who now have anaplastic glioma with no prior radiation or chemotherapy are eligible for the study.

3. 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.

4. Concomitant serious immunocompromised status (other than that related to concomitant steroids).

5. Patients known to be Human Immunodeficiency Virus (HIV) positive and currently receiving retroviral therapy. Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study.

6. 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.

7. Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.

8. Other active malignancy within 5 years of registration. Exceptions:

Non-melanotic skin cancer or carcinoma in situ of the cervix. Note: if there is a history of prior malignancy, the patient must not be receiving other specific treatment (other than hormonal therapy) for their cancer.

9. History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.

10. Recent history of hepatitis infection or treating physician determined that the patient would be at significant risk of reactivation of hepatitis.

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

European Organization for Research and Treatment of Cancer

Radiation Therapy Oncology Group

Kurt A. JaeckleStudy Chair

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 John Fiveash Ph: 205-934-0309
Alaska
  Anchorage
 Alaska Women's Cancer Care
 Alison K Conlin Ph: 503-215-6412
 Anchorage Oncology Centre
 Alison K Conlin Ph: 503-215-6412
 Providence Cancer Center
 Jeanne E. Anderson Ph: 907-261-3109
Arizona
  Phoenix
 Arizona Oncology - Deer Valley Center
 David G. Brachman Ph: 800-360-6371
  Scottsdale
 Arizona Oncology Services Foundation
 David G. Brachman Ph: 800-360-6371
California
  Fresno
 California Cancer Center - Woodward Park Office
 Uzair B. Chaudhary Ph: 559-447-4050
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Jethro L Hu Ph: 310-423-8965
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
Florida
  Jacksonville
 Mayo Clinic - Jacksonville
 Kurt A. Jaeckle Ph: 507-538-7623
Georgia
  Atlanta
 Piedmont Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: ORS@piedmont.org
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Priya U Kumthekar Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Edward Melian Ph: 708-226-4357
Indiana
  South Bend
 Memorial Hospital of South Bend
 Thomas Joseph Reid Ph: 800-284-7370
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Kentucky
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Aaron C Spalding Ph: 502-629-2500
Maryland
  Rockville
 Cancer Trials Support Unit
 Kurt A. Jaeckle
Massachusetts
  Boston
 Massachusetts General Hospital
 Helen A Shih Ph: 877-726-5130
Michigan
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Robert Anthony Chapman Ph: 313-916-1784
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Kalamazoo
 West Michigan Cancer Center
 Sunil Nagpal Ph: 269-373-7458
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Peter Y. Chen Ph: 248-551-7695
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Troy
 William Beaumont Hospital - Troy Campus
 Peter Y. Chen Ph: 248-551-7695
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Louis Park
 Park Nicollet Cancer Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David D Tran Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 402-991-8070ext202
  Email: mwilwerding@mvcc.cc
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 402-991-8070ext202
  Email: mwilwerding@mvcc.cc
 Fred and Pamela Buffett Cancer Center
 Nicole A Shonka Ph: 800-999-5465
 Immanuel Medical Center
 Gamini S. Soori Ph: 402-991-8070ext202
  Email: mwilwerding@mvcc.cc
 Lakeside Hospital
 Gamini S. Soori Ph: 402-991-8070ext202
  Email: mwilwerding@mvcc.cc
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Camilo E. Fadul Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Fa-Chyi Lee Ph: 505-272-6972
New York
  Rochester
 Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
 Yuhchyau Chen Ph: 585-275-5830
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
North Dakota
  Grand Forks
 Altru Cancer Center at Altru Hospital
 Grant R Seeger Ph: 701-780-6520
Ohio
  Cleveland
 Case Comprehensive Cancer Center
 Joseph Gibbons Ph: 800-641-2422
 Cleveland Clinic Taussig Cancer Center
 Samuel T Chao Ph: 866-223-8100
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Kurt A. Jaeckle
  Email: jaeckle.kurt@mayo.edu
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 800-446-5532
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 800-446-5532
  Wooster
 Cleveland Clinic - Wooster
 Samuel T Chao Ph: 866-223-8100
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence S. Herman Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison K Conlin Ph: 503-215-6412
  Gresham
 Legacy Mount Hood Medical Center
 Andrew Y Kee Ph: 507-538-7623
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Andrew Y Kee Ph: 507-538-7623
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Alison K Conlin Ph: 503-215-6412
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Wayne H Pinover Ph: 215-481-2402
  Bethlehem
 St. Luke's Cancer Network at St. Luke's Hospital
 Hugh D Moulding Ph: 610-954-3582
  Email: infolink@slhn.org
  Pittsburgh
 UPMC Cancer Centers
 David A Clump Ph: 412-621-2334
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Scott M Lindhorst Ph: 843-792-9321
  Greenville
 Cancer Centers of the Carolinas - Andrews
 David L Grisell Ph: 864-241-6251
 Cancer Centers of the Carolinas - Faris Road
 David L Grisell Ph: 864-241-6251
 Cancer Centers of the Carolinas - Grove Commons
 David L Grisell Ph: 864-241-6251
 CCOP - Greenville
 David L Grisell Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 David L Grisell Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 David L Grisell Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 David L Grisell Ph: 864-241-6251
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 James Dewitt Bearden Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Richard C Tenglin Ph: 605-716-3982
  Email: research@rcrh.org
Tennessee
  Nashville
 Vanderbilt-Ingram Cancer Center
 Paul L. Moots Ph: 800-811-8480
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Edward Pan Ph: 214-648-7097
Utah
  Cedar City
 Sandra L. Maxwell Cancer Center
 R. Jeffrey Lee Ph: 801-507-3950
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 R. Jeffrey Lee Ph: 801-507-3950
  Provo
 Utah Valley Regional Medical Center - Provo
 R. Jeffrey Lee Ph: 801-507-3950
  Saint George
 Dixie Regional Medical Center - East Campus
 R. Jeffrey Lee Ph: 801-507-3950
  Salt Lake City
 LDS Hospital
 R. Jeffrey Lee Ph: 801-507-3950
 Utah Cancer Specialists at UCS Cancer Center
 R. Jeffrey Lee Ph: 801-507-3950
Virginia
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Mark G Malkin Ph: 804-628-1939
Washington
  Mount Vernon
 Skagit Valley Hospital Cancer Care Center
 George E. Laramore Ph: 206-616-8289
  Seattle
 CCOP - Virginia Mason Research Center
 Craig R. Nichols Ph: 503-215-6412
  Email: vmmc.cancer_clinical_research@VirginiaMason.org
 University Cancer Center at University of Washington Medical Center
 George E. Laramore Ph: 206-616-8289
  Vancouver
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
Wisconsin
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Joseph A Bovi Ph: 414-805-4380
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Timothy R Wassenaar Ph: 262-928-7878
Austria
  Vienna
 Medical University of Vienna
 Kurt A. Jaeckle
Belgium
  Antwerpen
 Alegemeen Ziekenhuis Middelheim
 Kurt A. Jaeckle Ph: 904-953-7102
  Email: jaeckle.kurt@mayo.edu
France
  Lyon
 Centre Leon Berard
 Kurt A. Jaeckle
  Nice
 Centre Antoine Lacassagne
 Kurt A. Jaeckle Ph: 904-953-7102
  Email: jaeckle.kurt@mayo.edu
  Villejuif
 Institut Gustave Roussy
 Kurt A. Jaeckle
Netherlands
  Amsterdam
 Academ Zienkenhuis Bij De University
 Kurt A. Jaeckle
  Groningen
 University Medical Center Groningen
 Kurt A. Jaeckle
  Maastricht
 University Hospital Maastricht
 Kurt A. Jaeckle Ph: 904-953-7102
  Email: jaeckle.kurt@mayo.edu
  Rotterdam
 Erasmus University Medical Center
 Kurt A. Jaeckle

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00887146
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.