Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00978458
First received: September 16, 2009
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 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 radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma.

PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it works when given together with or without temozolomide in treating patients with low-grade glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Neurotoxicity
Drug: temozolomide
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Designated as safety issue: No ]
  • Overall survival (OS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life as assessed by the FACT-BR questionnaire at baseline, annually until disease progression, and at the time of disease progression [ Designated as safety issue: No ]
  • Neurocognitive functioning as assessed at baseline, annually until disease progression, and at the time of disease progression [ Designated as safety issue: No ]
  • Correlation of pre-treatment 1p and 19q levels in tumor tissue samples with PFS and OS [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: September 2009
Estimated Primary Completion Date: May 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions).
Radiation: 3-dimensional conformal radiation therapy
Given once daily 5 days a week for 5½ weeks
Radiation: intensity-modulated radiation therapy
Given once daily 5 days a week for 5½ weeks
Experimental: Arm II
Patients undergo radiotherapy as in arm I and receive concurrent oral temozolomide once daily for 5½ weeks. Beginning 28 days after completion of chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: temozolomide
Given orally
Radiation: 3-dimensional conformal radiation therapy
Given once daily 5 days a week for 5½ weeks
Radiation: intensity-modulated radiation therapy
Given once daily 5 days a week for 5½ weeks

Detailed Description:

OBJECTIVES:

Primary

  • To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients with symptomatic or progressive low-grade gliomas.
  • To determine whether the addition of temozolomide to fractionated radiotherapy improves the median overall survival (OS) of these patients.

Secondary

  • To determine whether combination therapy with temozolomide and radiotherapy improves or maintains cognition and quality of life compared to radiotherapy alone.
  • To compare the toxicities (severe or worse [≥ grade 3]) of radiotherapy with vs without temozolomide in these patients.
  • To assess the impact of the presence or absence of 1p and 19q deletion on PFS and OS.
  • To determine the impact of 1p and 19q status on PFS and OS of patients treated with temozolomide.
  • To create a tumor and tissue bank, including plasma and germ line DNA, within the ECOG Pathology Coordinating Office.

OUTLINE: This is a multicenter study. Patients are stratified according to age (< 40 years vs ≥ 40 years), 1p and 19q status (both deleted vs either/both intact vs undeterminable), pre-operative maximum tumor diameter (< 6 cm vs ≥ 6 cm [based on T2 or FLAIR MRI]), Karnofsky performance status (60-70% vs 80-100%), and contrast enhancement on pre-treatment MRI scan (present vs absent). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions).
  • Arm II: Patients undergo radiotherapy as in arm I and receive concurrent oral temozolomide once daily for 5½ weeks. Beginning 28 days after completion of chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

Some patients undergo quality-of-life and neurocognitive (e.g., visual scanning speed, divided attention, language, memory, and fine motor skills) assessments at baseline, annually until disease progression, and at the time of disease progression.

Tumor tissue samples are collected at baseline for confirmation of diagnosis and determination of 1p and 19q deletion status. Peripheral blood, serum, and additional tumor tissue samples may be collected for further research studies.

After completion of study treatment, patients are followed up periodically for up to 15 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed* supratentorial low-grade glioma, including 1 of the following:

    • Grade 2 astrocytoma
    • Grade 2 oligodendroglioma
    • Grade 2 oligoastrocytoma (mixed glioma containing astrocytoma and oligodendroglioma)
  • NOTE: *If the pathology from multiple procedures supports the diagnosis of a brain tumor, the qualifying pathology of grade 2 astrocytoma, oligodendroglioma, or oligoastrocytoma must be the most recent pathological diagnosis; no pathological diagnosis of grade 3 or 4 glioma at any time
  • Paraffin-embedded tumor specimen available for submission for confirmation of pathological review and determination of 1p and 19q deletion status
  • Patients must currently meet ≥ 1 of the following criteria*:

    • Uncontrolled symptoms, defined as any of the following:

      • Headaches associated with mass effect
      • Uncontrolled seizures despite two different antiepileptic drug regimens (i.e., two antiepileptic drugs tested either sequentially or in combination)
      • Focal neurological symptoms
      • Cognitive symptoms or deficits
    • Tumor progression by serial MRIs, defined as any of the following:

      • New or progressive enhancement
      • New or progressive T2 or FLAIR signal abnormality
    • Age ≥ 40 years
  • NOTE: *Patients < 40 years of age whose only symptom of low-grade glioma is seizures that are well-controlled on antiepileptic drugs AND who have no evidence of radiographic progression are not eligible.
  • Patients who have undergone gross total resection and have no detectable residual disease are eligible
  • No pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, or dysembryoplastic neuroepithelial tumors

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • WBC ≥ 3,000/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hematocrit ≥ 30%
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN
  • Creatinine ≤ 2.0 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Able to undergo MRI with and without contrast
  • No other malignancy within the past 5 years, except for nonmelanoma skin cancer or cervical carcinoma in situ
  • No uncontrolled infection
  • No known HIV positivity
  • No medical disorder that would increase risks associated with radiotherapy and temozolomide
  • No other disorder that would limit life expectancy to < 5 years

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy, cytotoxic chemotherapy, radiosurgery, or investigational therapy directed at the brain tumor

    • Any number of prior surgical procedures for the brain tumor allowed
  • No prior radiotherapy to the head unless the radiotherapy ports entirely excluded the brain
  • At least 2 weeks since any prior brain surgery (e.g., stereotatic biopsy, open biopsy, or resection)
  • At least 6 weeks since prior MRI and chest x-ray

    • If resection is performed, an MRI after surgery is required
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978458

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center    205-934-0309      
United States, Arizona
Arizona Oncology Services Foundation Recruiting
Phoenix, Arizona, United States, 85013
Contact: David G. Brachman, MD, FACRO    602-274-4484      
United States, California
Rebecca and John Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer    858-822-5354    cancercto@ucsd.edu   
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent    877-UC-STUDY    ucstudy@uci.edu   
United States, Colorado
Aurora Presbyterian Hospital Recruiting
Aurora, Colorado, United States, 80012
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
St. Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Presbyterian - St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen    303-839-6000      
St. Anthony Central Hospital Recruiting
Denver, Colorado, United States, 80204
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
CCOP - Colorado Cancer Research Program Recruiting
Denver, Colorado, United States, 80222
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Sky Ridge Medical Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
United States, Connecticut
Eastern Connecticut Hematology and Oncology Associates Recruiting
Norwich, Connecticut, United States, 06360
Contact: Dennis E. Slater, MD    860-886-8362      
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute    407-303-5623      
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Clinical Trials Office - Winship Cancer Institute    404-778-1900      
United States, Illinois
St. Joseph Medical Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    309-662-3311      
Illinois CancerCare - Bloomington Recruiting
Bloomington%, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Graham Hospital Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    309-647-5240      
Illinois CancerCare - Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    309-647-5240      
Illinois CancerCare - Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    217-357-6877      
Memorial Hospital Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    217-357-3131      
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center    312-355-3046      
John H. Stroger, Jr. Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-3785
Contact: George R. Cybulsky    312-864-3200      
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301    cancer@northwestern.edu   
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care    217-876-4750      
Eureka Community Hospital Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Illinois CancerCare - Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201-1781
Contact: Clinical Trials Office - Evanston Hospital    847-570-1381      
Galesburg Clinic, PC Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    309-344-1000      
Illinois CancerCare - Havana Recruiting
Havana, Illinois, United States, 62644
Contact: Nguyet A. Le-Lindqwister    309-543-8557      
Illinois CancerCare - Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Nguyet A. Le-Lindqwister    309-852-0598      
La Grange Memorial Hospital Recruiting
La Grange, Illinois, United States, 60525
Contact: Clinical Trials Office - La Grange Memorial Hospital    630-856-7526      
Illinois CancerCare - Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    309-833-3503      
McDonough District Hospital Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    309-833-4101      
OSF Holy Family Medical Center Recruiting
Monmouth, Illinois, United States, 61462
Contact: Nguyet A. Le-Lindqwister    309-734-3141      
Illinois CancerCare - Monmouth Recruiting
Monmouth, Illinois, United States, 61462
Contact: Nguyet A. Le-Lindqwister    309-734-3141      
BroMenn Regional Medical Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-454-1400      
Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-451-8500      
Illinois CancerCare - Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Community Hospital of Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-433-3100      
Oncology Hematology Associates of Central Illinois, PC - Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-431-9270      
Illinois CancerCare - Pekin Recruiting
Pekin, Illinois, United States, 61603
Contact: Nguyet A. Le-Lindqwister    309-353-0214      
Cancer Treatment Center at Pekin Hospital Recruiting
Pekin, Illinois, United States, 61554
Contact: Nguyet A. Le-Lindqwister    309-353-0512      
Oncology Hematology Associates of Central Illinois, PC - Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3000      
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Clinical Trials Office - Methodist Medical Center of Illinois    309-243-3000      
OSF St. Francis Medical Center Recruiting
Peoria, Illinois, United States, 61615-7827
Contact: Nguyet A. Le-Lindqwister    309-655-2000      
Proctor Hospital Recruiting
Peoria, Illinois, United States, 61614
Contact: Nguyet A. Le-Lindqwister    309-691-1000      
CCOP - Illinois Oncology Research Association Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3605      
Illinois CancerCare - Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-780-3185      
Illinois Valley Community Hospital Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-223-3000      
Illinois CancerCare - Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Nguyet A. Le-Lindqwister    815-875-3010      
Illinois CancerCare - Spring Valley Recruiting
Spring Valley, Illinois, United States, 61362
Contact: Nguyet A. Le-Lindqwister    815-664-1487      
Valley Cancer Center Recruiting
Spring Valley, Illinois, United States, 61362
Contact: Nguyet A. Le-Lindqwister    815-664-4141      
United States, Indiana
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Bilal Ansari, MD    269-983-8260      
Parkview Regional Cancer Center at Parkview Health Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang    260-373-7850      
Radiation Oncology Associates Southwest Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Brian K. Chang    260-436-4116      
Community Regional Cancer Care at Community Hospital East Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Shih J. Wei    317-355-5347      
Community Regional Cancer Care at Community Hospital North Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Shih J. Wei    317-621-4300      
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
Contact: Bilal Ansari, MD    269-983-8260      
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: Bilal Ansari, MD    269-983-8260      
Michiana Hematology-Oncology, PC - South Bend Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Bilal Ansari, MD    269-983-8260      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend    800-284-7370      
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Bilal Ansari, MD    269-983-8260      
United States, Iowa
CCOP - Iowa Oncology Research Association Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    515-244-7586      
Mercy Cancer Center at Mercy Medical Center - North Iowa Recruiting
Mason City, Iowa, United States, 50401
Contact: Clinical Trials Office - Mercy Cancer Center at Mercy Medical    641-422-6304      
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Kansas
Cancer Center of Kansas, PA - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
CCOP - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Via Christi Cancer Center at Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
United States, Kentucky
Louisville Oncology at Norton Cancer Institute - Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Clinical Trials Office - Louisville Oncology    502-629-2500      
Norton Suburban Hospital Recruiting
Louisville, Kentucky, United States, 40207
Contact: Aaron C. Spalding    502-893-1000      
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Recruiting
Scarborough, Maine, United States, 04074
Contact: Ian J. Bristol    207-885-7600      
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce    410-955-8804    jhcccro@jhmi.edu   
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Robert A. Chapman, MD    313-916-1332      
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute    810-762-8057      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center    810-762-8057      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
Lakeside Cancer Specialists, PLLC Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Bilal Ansari, MD    269-983-8260      
Lakeland Regional Cancer Care Center - St. Joseph Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Bilal Ansari, MD    269-983-8260      
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Joseph W. Leach    952-892-2000      
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Joseph W. Leach    763-236-6000      
CCOP - Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital    612-625-3650      
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Joseph W. Leach    763-236-5000      
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Joseph W. Leach    320-234-5000      
Minnesota Oncology - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Joseph W. Leach    651-779-7978      
HealthEast Cancer Care at St. John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Joseph W. Leach    651-232-7970      
Hennepin County Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Clinical Trials Office - Hennepin County Medical Center - Minn    612-873-5911      
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute    612-863-5654      
Humphrey Cancer Center at North Memorial Outpatient Center Recruiting
Robbinsdale, Minnesota, United States, 55422-2900
Contact: Clinical Trials Office - Humphrey Cancer Center at North Memor    763-520-1893      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-3248      
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-1517      
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Joseph W. Leach    651-241-8000      
St. Francis Cancer Center at St. Francis Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Joseph W. Leach    952-403-2031      
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center    651-254-1517      
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Joseph W. Leach    651-439-5330      
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Joseph W. Leach    952-442-2191      
Willmar Cancer Center at Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Joseph W. Leach    320-231-4650      
Minnesota Oncology - Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Joseph W. Leach    651-735-7414      
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
United States, Nebraska
Cancer Resource Center - Lincoln Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Gamini S. Soori, MD, FACP, FRCP, MBA    402-393-3110      
CCOP - Missouri Valley Cancer Consortium Recruiting
Omaha, Nebraska, United States, 68106
Contact: Gamini S. Soori, MD, FACP, FRCP, MBA    402-393-3110      
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Tien-Shew W. Huang    402-354-5890      
Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Weining K. Zhen, MD    402-552-3844      
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center    603-650-7609    cancerhelp@dartmouth.edu   
United States, New York
New York Oncology Hematology, PC at Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Charles H. Weissman    518-262-6696      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Thomas J. Kaley    212-639-8895      
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi    315-464-5476      
United States, North Carolina
Mission Hospitals - Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus    828-213-4150      
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: Jennifer E. Payne    330-745-1611      
Charles M. Barrett Cancer Center at University Hospital Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Luke E. Pater    513-584-3200      
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
United States, Oregon
Legacy Mount Hood Medical Center Recruiting
Gresham, Oregon, United States, 97030
Contact: Clinical Trials Office - Legacy Mount Hood Medical Center    503-413-2150      
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Recruiting
Portland, Oregon, United States, 97210
Contact: Clinical Trials Office - Legacy Good Samaritan Hospital & Com    503-413-1742      
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Eliot L. Friedman, MD    610-402-0512      
St. Luke's Cancer Network at St. Luke's Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Sanjiv S. Agarwala, MD    610-954-2145      
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer    215-955-6084      
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni    843-792-9321      
Cancer Centers of the Carolinas - Faris Road Recruiting
Greenville, South Carolina, United States, 29605
Contact: David L. Grisell    864-679-3900      
Cancer Centers of the Carolinas - Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Clinical Trials Office - Cancer Centers of the Carolinas    864-241-6251      
Cancer Centers of the Carolinas - Grove Commons Recruiting
Greenville, South Carolina, United States, 29605
Contact: Clinical Trials Office - Cancer Centers of the Carolinas    864-241-6251      
CCOP - Greenville Recruiting
Greenville, South Carolina, United States, 29615
Contact: David L. Grisell    864-241-6251      
Cancer Centers of the Carolinas - Greer Radiation Oncology Recruiting
Greer, South Carolina, United States, 29650
Contact: David L. Grisell    864-334-4900      
Cancer Centers of the Carolinas - Greer Medical Oncology Recruiting
Greer, South Carolina, United States, 29650
Contact: David L. Grisell    864-662-4000      
Cancer Centers of the Carolinas - Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: David L. Grisell    864-888-3717      
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - Gibbs Regional Cancer Center    800-486-5941      
Cancer Centers of the Carolinas - Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: David L. Grisell    864-699-5700      
CCOP - Upstate Carolina Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - CCOP - Upstate Carolina    800-486-5941      
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Richard C. Tenglin    605-719-2360      
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center    605-328-1367      
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a    866-460-4673; 214-648-7097      
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0361
Contact: Clinical Trials Office - University of Texas Medical Branch    409-772-1950      
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U    713-792-3245      
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: R. Jeffrey Lee, MD    801-408-1146      
Utah Valley Regional Medical Center - Provo Recruiting
Provo, Utah, United States, 84604
Contact: Clinical Trials Office - Utah Valley Regional Medical Center -    801-357-7965      
Dixie Regional Medical Center - East Campus Recruiting
Saint George, Utah, United States, 84770
Contact: Clinical Trials Office - Dixie Regional Medical Center - East    435-688-4167      
United States, Virginia
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse    804-628-1939      
United States, Washington
University Cancer Center at University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: George E. Laramore, PhD, MD, FACR    206-598-4110      
CCOP - Virginia Mason Research Center Recruiting
Seattle, Washington, United States, 98101
Contact: Craig R. Nichols, MD    503-494-6346      
Legacy Salmon Creek Medical Center Recruiting
Vancouver, Washington, United States, 98686
Contact: Ian D. Schnadig    360-487-1000      
United States, Wisconsin
Theda Care Cancer Institute Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Clinical Trials Office - Theda Care Cancer Institute    920-380-1500      
Marshfield Clinic Cancer Care at Regional Cancer Center Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Benjamin E. Lawler    715-389-3133      
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo    608-262-5223      
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center    800-782-1581 ext. 94457      
Saint Joseph's Hospital Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Benjamin E. Lawler    715-389-3133      
Columbia Saint Mary's Hospital - Ozaukee Recruiting
Mequon, Wisconsin, United States, 53097
Contact: Carl E. Olson, MD    414-291-1556      
Columbia-Saint Mary's Cancer Care Center Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Clinical Trials Office - Columbia-St. Mary's Cancer Care Cente    414-326-1739      
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C    414-805-4380      
Marshfield Clinic - Lakeland Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Benjamin E. Lawler    715-389-3133      
Ministry Medical Group at Saint Mary's Hospital Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Benjamin E. Lawler    715-389-3133      
Marshfield Clinic - Indianhead Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Benjamin E. Lawler    715-389-3133      
Marshfield Clinic at Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Benjamin E. Lawler    715-389-3133      
Waukesha Memorial Hospital Regional Cancer Center Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C    262-928-7632      
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Benjamin E. Lawler    715-389-3133      
Diagnostic and Treatment Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Benjamin E. Lawler    715-389-3133      
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: David Schiff, MD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT00978458     History of Changes
Other Study ID Numbers: CDR0000654697, ECOG-E3F05
Study First Received: September 16, 2009
Last Updated: December 4, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
neurotoxicity
adult diffuse astrocytoma
adult oligodendroglioma
recurrent adult brain tumor
adult mixed glioma

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neurotoxicity Syndromes
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
Poisoning
Substance-Related Disorders
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014