Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
- Conditions
- NeurotoxicityBrain and Central Nervous System Tumors
- Interventions
- Radiation: 3-dimensional conformal radiation therapyRadiation: intensity-modulated radiation therapy
- Registration Number
- NCT00978458
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 540
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I 3-dimensional conformal radiation therapy Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions). Arm I intensity-modulated radiation therapy Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions). Arm II intensity-modulated radiation therapy 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. Arm II 3-dimensional conformal radiation therapy 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. Arm II temozolomide 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.
- Primary Outcome Measures
Name Time Method Overall survival (OS) Progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method Neurocognitive functioning as assessed at baseline, annually until disease progression, and at the time of disease progression Quality of life as assessed by the FACT-BR questionnaire at baseline, annually until disease progression, and at the time of disease progression Correlation of pre-treatment 1p and 19q levels in tumor tissue samples with PFS and OS
Trial Locations
- Locations (168)
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Illinois CancerCare - Eureka
🇺🇸Eureka, Illinois, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
Illinois CancerCare - Havana
🇺🇸Havana, Illinois, United States
Illinois CancerCare - Princeton
🇺🇸Princeton, Illinois, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Theda Care Cancer Institute
🇺🇸Appleton, Wisconsin, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Arizona Oncology Services Foundation
🇺🇸Phoenix, Arizona, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
John H. Stroger, Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Illinois CancerCare - Kewanee Clinic
🇺🇸Kewanee, Illinois, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Illinois CancerCare - Bloomington
🇺🇸Bloomington, Illinois, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Illinois CancerCare - Canton
🇺🇸Canton, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Illinois CancerCare - Monmouth
🇺🇸Monmouth, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, 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
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Radiation Oncology Associates Southwest
🇺🇸Fort Wayne, Indiana, United States
Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Michiana Hematology-Oncology, PC - South Bend
🇺🇸Mishawaka, Indiana, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
🇺🇸Scarborough, Maine, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Lakeside Cancer Specialists, PLLC
🇺🇸Saint Joseph, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Minnesota Oncology - Woodbury
🇺🇸Woodbury, Minnesota, United States
St. Luke's Cancer Network at St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Regions Hospital Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
Park Nicollet Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Willmar Cancer Center at Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Barberton Citizens Hospital
🇺🇸Barberton, Ohio, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Cancer Centers of the Carolinas - Grove Commons
🇺🇸Greenville, South Carolina, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, 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
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Marshfield Clinic - Lakeland Center
🇺🇸Minocqua, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
🇺🇸La Crosse, Wisconsin, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital
🇺🇸Stevens Point, Wisconsin, United States
Diagnostic and Treatment Center
🇺🇸Weston, Wisconsin, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
Minnesota Oncology - Maplewood
🇺🇸Maplewood, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Illinois CancerCare - Carthage
🇺🇸Carthage, Illinois, United States
La Grange Memorial Hospital
🇺🇸La Grange, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Illinois CancerCare - Peru
🇺🇸Peru, Illinois, United States
Community Regional Cancer Care at Community Hospital East
🇺🇸Indianapolis, Indiana, United States
Illinois CancerCare - Spring Valley
🇺🇸Spring Valley, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Community Regional Cancer Care at Community Hospital North
🇺🇸Indianapolis, Indiana, 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
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Columbia Saint Mary's Hospital - Ozaukee
🇺🇸Mequon, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
🇺🇸Rhinelander, Wisconsin, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Columbia-Saint Mary's Cancer Care Center
🇺🇸Milwaukee, Wisconsin, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Illinois CancerCare - Macomb
🇺🇸Macomb, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Illinois CancerCare - Community Cancer Center
🇺🇸Normal, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Illinois CancerCare - Pekin
🇺🇸Pekin, Illinois, United States
Parkview Regional Cancer Center at Parkview Health
🇺🇸Fort Wayne, Indiana, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Legacy Salmon Creek Medical Center
🇺🇸Vancouver, Washington, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
🇺🇸Eau Claire, Wisconsin, United States
Saint Joseph's Hospital
🇺🇸Marshfield, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
🇺🇸Waukesha, Wisconsin, United States
Marshfield Clinic - Indianhead Center
🇺🇸Rice Lake, Wisconsin, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Louisville Oncology at Norton Cancer Institute - Louisville
🇺🇸Louisville, Kentucky, United States
Norton Suburban Hospital
🇺🇸Louisville, Kentucky, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Cancer Centers of the Carolinas - Faris Road
🇺🇸Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Eastside
🇺🇸Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Greer Medical Oncology
🇺🇸Greer, South Carolina, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Cancer Centers of the Carolinas - Seneca
🇺🇸Seneca, South Carolina, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Cancer Centers of the Carolinas - Greer Radiation Oncology
🇺🇸Greer, South Carolina, United States
OSF Holy Family Medical Center
🇺🇸Monmouth, Illinois, United States