A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas
- Compare the 3-year survival of patients with high-risk low-grade gliomas treated with
temozolomide and radiotherapy followed by temozolomide alone with that of patients
enrolled on European Organization for Research and Treatment of Cancer (EORTC)clinical
trials EORTC-22844 and EORTC-22845.
- Determine the toxicity of this regimen in these patients.
- Determine the association between progression-free survival and O6-methylguanine-DNA
methyltransferase (MGMT) methylation status in patients treated with this regimen.
- Determine the association between survival and MGMT methylation status in patients
treated with this regimen.
- Determine the quality of life (QOL) of patients treated with this regimen.
- Determine the neurocognitive function of patients treated with this regimen.
- Evaluate the feasibility of collecting patient-reported QOL and neurocognitive
assessments over 3 years.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive oral temozolomide once daily on days 1-42 and undergo radiotherapy once
daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning 28 days after completion
of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment
with temozolomide repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed periodically for up to 36 months.
After completion of study treatment, patients are followed at 4 months, every 6 months for 2
years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 44 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival at 3 years.
Death of last follow-up. Analysis occurs after all patients have been potentially followed for 3 years
Barbara J. Fisher, MD
London Regional Cancer Program at London Health Sciences Centre
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Sparrow Regional Cancer Center||Lansing, Michigan 48912-1811|
|Aultman Cancer Center at Aultman Hospital||Canton, Ohio 44710-1799|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|Mission Hospitals - Memorial Campus||Asheville, North Carolina 28801|
|St. Vincent Hospital Regional Cancer Center||Green Bay, Wisconsin 54307-3508|
|Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center||Green Bay, Wisconsin 54301-3526|
|Bay Area Cancer Care Center at Bay Area Medical Center||Marinette, Wisconsin 54143|
|Baptist Cancer Institute - Jacksonville||Jacksonville, Florida 32207|
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|Gundersen Lutheran Center for Cancer and Blood||La Crosse, Wisconsin 54601|
|Methodist Estabrook Cancer Center||Omaha, Nebraska 68114-4199|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Dixie Regional Medical Center - East Campus||Saint George, Utah 84770|
|DeCesaris Cancer Institute at Anne Arundel Medical Center||Annapolis, Maryland 21401|
|Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford||Salem, Ohio 44460|
|Cancer Treatment Center||Wooster, Ohio 44691|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|Jon and Karen Huntsman Cancer Center at Intermountain Medical Center||Murray, Utah 84157|
|Arizona Oncology Services Foundation||Phoenix, Arizona 85013|
|Integrated Community Oncology Network||Jacksonville Beach, Florida 32250|
|Baptist Medical Center South||Jascksonville, Florida 32258|
|Florida Cancer Center - Palatka||Palatka, Florida 32177|
|Flagler Cancer Center||Saint Augustine, Florida 32086|
|Integrated Community Oncology Network - Orange Park||Orange Park, Florida 32073|
|Integrated Community Oncology Network at Southside Cancer Center||Jacksonville, Florida 32207|