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

NCT00978458 | Active Not Recruiting Phase 3

• 2 other identifiers: E3F05ECOG-E3F05
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 168

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.

Conditions

Brain and Central Nervous System Tumors; Neurotoxicity

Keywords

neurotoxicity; adult diffuse astrocytoma; adult oligodendroglioma; recurrent adult brain tumor; adult mixed glioma

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

• Overall survival (OS)

Secondary Outcomes (3)

• Quality of life as assessed by the FACT-BR questionnaire at baseline, annually until disease progression, and at the time of disease progression

• Neurocognitive functioning as assessed 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

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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; Radiation: intensity-modulated radiation therapy

Arm II

EXPERIMENTAL

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; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy

Interventions

temozolomide DRUG

Given orally

Arm II

3-dimensional conformal radiation therapy RADIATION

Given once daily 5 days a week for 5½ weeks

Arm I; Arm II

intensity-modulated radiation therapy RADIATION

Given once daily 5 days a week for 5½ weeks

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (168)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Aurora Presbyterian Hospital

Aurora, Colorado, 80012, United States

Location

St. Anthony Central Hospital

Denver, Colorado, 80204, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218, United States

Location

CCOP - Colorado Cancer Research Program

Denver, Colorado, 80222, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Illinois CancerCare - Bloomington

Bloomington, Illinois, 61701, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Illinois CancerCare - Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare - Carthage

Carthage, Illinois, 62321, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612-3785, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare - Eureka

Eureka, Illinois, 61530, United States

Location

Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Galesburg Clinic, PC

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare - Havana

Havana, Illinois, 62644, United States

Location

Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

La Grange Memorial Hospital

La Grange, Illinois, 60525, United States

Location

Illinois CancerCare - Macomb

Macomb, Illinois, 61455, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

Illinois CancerCare - Monmouth

Monmouth, Illinois, 61462, United States

Location

OSF Holy Family Medical Center

Monmouth, Illinois, 61462, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Illinois CancerCare - Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare - Pekin

Pekin, Illinois, 61603, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61615-7827, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

Illinois CancerCare - Peru

Peru, Illinois, 61354, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Illinois CancerCare - Princeton

Princeton, Illinois, 61356, United States

Location

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, 61362, United States

Location

Valley Cancer Center

Spring Valley, Illinois, 61362, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Radiation Oncology Associates Southwest

Fort Wayne, Indiana, 46804, United States

Location

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, 46805, United States

Location

Community Regional Cancer Care at Community Hospital East

Indianapolis, Indiana, 46219, United States

Location

Community Regional Cancer Care at Community Hospital North

Indianapolis, Indiana, 46256, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, 46545-1470, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

Mercy Cancer Center at Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Louisville Oncology at Norton Cancer Institute - Louisville

Louisville, Kentucky, 40202, United States

Location

Norton Suburban Hospital

Louisville, Kentucky, 40207, United States

Location

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, 04074, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, 49085, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Minnesota Oncology - Maplewood

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, 55379, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Willmar Cancer Center at Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Minnesota Oncology - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Cancer Resource Center - Lincoln

Lincoln, Nebraska, 68510, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

New York Oncology Hematology, PC at Albany Medical Center

Albany, New York, 12208, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Barberton Citizens Hospital

Barberton, Ohio, 44203, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Legacy Good Samaritan Hospital & Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18105, United States

Location

St. Luke's Cancer Network at St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, 29605, United States

Location

Cancer Centers of the Carolinas - Grove Commons

Greenville, South Carolina, 29605, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Cancer Centers of the Carolinas - Greer Medical Oncology

Greer, South Carolina, 29650, United States

Location

Cancer Centers of the Carolinas - Greer Radiation Oncology

Greer, South Carolina, 29650, United States

Location

Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, 29672, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Legacy Salmon Creek Medical Center

Vancouver, Washington, 98686, United States

Location

Theda Care Cancer Institute

Appleton, Wisconsin, 54911, United States

Location

Marshfield Clinic Cancer Care at Regional Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Saint Joseph's Hospital

Marshfield, Wisconsin, 54449, United States

Location

Columbia Saint Mary's Hospital - Ozaukee

Mequon, Wisconsin, 53097, United States

Location

Columbia-Saint Mary's Cancer Care Center

Milwaukee, Wisconsin, 53211, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, 54548, United States

Location

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, 54501, United States

Location

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Clinic at Saint Michael's Hospital

Stevens Point, Wisconsin, 54481, United States

Location

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, 53188, United States

Location

Diagnostic and Treatment Center

Weston, Wisconsin, 54476, United States

Location

Marshfield Clinic - Weston Center

Weston, Wisconsin, 54476, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neurotoxicity Syndromes; Astrocytoma; Oligodendroglioma; Brain Neoplasms; Glioma

Interventions

Temozolomide; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• David Schiff, MD

  University of Virginia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: November 17, 2009
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

US (168)