Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
NCT ID: NCT00978458
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
540 participants
INTERVENTIONAL
2009-11-17
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Arm I
Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions).
3-dimensional conformal radiation therapy
Given once daily 5 days a week for 5½ weeks
intensity-modulated radiation therapy
Given once daily 5 days a week for 5½ weeks
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.
temozolomide
Given orally
3-dimensional conformal radiation therapy
Given once daily 5 days a week for 5½ weeks
intensity-modulated radiation therapy
Given once daily 5 days a week for 5½ weeks
Interventions
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temozolomide
Given orally
3-dimensional conformal radiation therapy
Given once daily 5 days a week for 5½ weeks
intensity-modulated radiation therapy
Given once daily 5 days a week for 5½ weeks
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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David Schiff, MD
Role: STUDY_CHAIR
University of Virginia
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
Aurora Presbyterian Hospital
Aurora, Colorado, United States
St. Anthony Central Hospital
Denver, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States
St. Joseph Hospital
Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Illinois CancerCare - Canton
Canton, Illinois, United States
Illinois CancerCare - Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Illinois CancerCare - Eureka
Eureka, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Galesburg Clinic, PC
Galesburg, Illinois, United States
Illinois CancerCare - Havana
Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States
La Grange Memorial Hospital
La Grange, Illinois, United States
Illinois CancerCare - Macomb
Macomb, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States
OSF Holy Family Medical Center
Monmouth, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Illinois CancerCare - Pekin
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare - Peru
Peru, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Illinois CancerCare - Princeton
Princeton, Illinois, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States
Valley Cancer Center
Spring Valley, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, United States
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Louisville Oncology at Norton Cancer Institute - Louisville
Louisville, Kentucky, United States
Norton Suburban Hospital
Louisville, Kentucky, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, United States
Billings Clinic - Downtown
Billings, Montana, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Oncology Hematology, PC at Albany Medical Center
Albany, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Greer Medical Oncology
Greer, South Carolina, United States
Cancer Centers of the Carolinas - Greer Radiation Oncology
Greer, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States
Theda Care Cancer Institute
Appleton, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Countries
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Other Identifiers
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ECOG-E3F05
Identifier Type: -
Identifier Source: secondary_id
E3F05
Identifier Type: -
Identifier Source: org_study_id
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