Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
Brain and Central Nervous System Tumors, Neurotoxicity
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring neurotoxicity, adult diffuse astrocytoma, adult oligodendroglioma, recurrent adult brain tumor, adult mixed glioma
Eligibility 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
Sites / Locations
- UAB Comprehensive Cancer Center
- Arizona Oncology Services Foundation
- Rebecca and John Moores UCSD Cancer Center
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Aurora Presbyterian Hospital
- St. Anthony Central Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- Sky Ridge Medical Center
- Eastern Connecticut Hematology and Oncology Associates
- CCOP - Christiana Care Health Services
- Mayo Clinic - Jacksonville
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Winship Cancer Institute of Emory University
- Illinois CancerCare - Bloomington
- St. Joseph Medical Center
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- John H. Stroger, Jr. Hospital of Cook County
- University of Illinois Cancer Center
- University of Chicago Cancer Research Center
- Decatur Memorial Hospital Cancer Care Institute
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Evanston Hospital
- Galesburg Clinic, PC
- Illinois CancerCare - Havana
- Illinois CancerCare - Kewanee Clinic
- La Grange Memorial Hospital
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Illinois CancerCare - Monmouth
- OSF Holy Family Medical Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- Proctor Hospital
- OSF St. Francis Medical Center
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Illinois CancerCare - Spring Valley
- Valley Cancer Center
- Elkhart General Hospital
- Radiation Oncology Associates Southwest
- Parkview Regional Cancer Center at Parkview Health
- Community Regional Cancer Care at Community Hospital East
- Community Regional Cancer Care at Community Hospital North
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Michiana Hematology-Oncology, PC - South Bend
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- CCOP - Iowa Oncology Research Association
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Siouxland Hematology-Oncology Associates, LLP
- Cancer Center of Kansas, PA - Wellington
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Louisville Oncology at Norton Cancer Institute - Louisville
- Norton Suburban Hospital
- Maine Center for Cancer Medicine and Blood Disorders - Scarborough
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Josephine Ford Cancer Center at Henry Ford Hospital
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- West Michigan Cancer Center
- Lakeland Regional Cancer Care Center - St. Joseph
- Lakeside Cancer Specialists, PLLC
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology - Woodbury
- Billings Clinic - Downtown
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Methodist Estabrook Cancer Center
- Nebraska Medical Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- New York Oncology Hematology, PC at Albany Medical Center
- Memorial Sloan-Kettering Cancer Center
- SUNY Upstate Medical University Hospital
- Mission Hospitals - Memorial Campus
- Wake Forest University Comprehensive Cancer Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Charles M. Barrett Cancer Center at University Hospital
- Case Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- Legacy Mount Hood Medical Center
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- St. Luke's Cancer Network at St. Luke's Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Hollings Cancer Center at Medical University of South Carolina
- Cancer Centers of the Carolinas - Faris Road
- Cancer Centers of the Carolinas - Grove Commons
- Cancer Centers of the Carolinas - Eastside
- CCOP - Greenville
- Cancer Centers of the Carolinas - Greer Medical Oncology
- Cancer Centers of the Carolinas - Greer Radiation Oncology
- Cancer Centers of the Carolinas - Seneca
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Cancer Centers of the Carolinas - Spartanburg
- Rapid City Regional Hospital
- Sanford Cancer Center at Sanford USD Medical Center
- Vanderbilt-Ingram Cancer Center
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- University of Texas Medical Branch
- M. D. Anderson Cancer Center at University of Texas
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Virginia Commonwealth University Massey Cancer Center
- CCOP - Virginia Mason Research Center
- University Cancer Center at University of Washington Medical Center
- Legacy Salmon Creek Medical Center
- Theda Care Cancer Institute
- Marshfield Clinic Cancer Care at Regional Cancer Center
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Columbia Saint Mary's Hospital - Ozaukee
- Columbia-Saint Mary's Cancer Care Center
- Medical College of Wisconsin Cancer Center
- Marshfield Clinic - Lakeland Center
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Marshfield Clinic at Saint Michael's Hospital
- Waukesha Memorial Hospital Regional Cancer Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I
Arm II
Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions).
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.