Spots Global Cancer Trial Database for Temozolomide and Radiation Therapy in Treating Patients With Gliomas
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Temozolomide and Radiation Therapy in Treating Patients With Gliomas
Official Title: A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas
Study ID: NCT00114140
Conditions
Study Description
Brief Summary: RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with low-grade gliomas.
Detailed Description: OBJECTIVES: * 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, one hour before RT weekdays, in the evening weekends. 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 at baseline, 6 months, 12 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Services Foundation, Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Integrated Community Oncology Network, Jacksonville Beach, Florida, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States
Integrated Community Oncology Network at Southside Cancer Center, Jacksonville, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Baptist Medical Center South, Jacksonville, Florida, United States
Integrated Community Oncology Network - Orange Park, Orange Park, Florida, United States
Florida Cancer Center - Palatka, Palatka, Florida, United States
Flagler Cancer Center, Saint Augustine, Florida, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center, Annapolis, Maryland, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Aultman Cancer Center at Aultman Hospital, Canton, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem, Ohio, United States
Cancer Treatment Center, Wooster, Ohio, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States
Dixie Regional Medical Center - East Campus, Saint George, Utah, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, 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
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Hopital Notre-Dame du CHUM, Montreal, Quebec, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Contact Details
Name: Barbara J. Fisher, MD
Affiliation: London Health Sciences Centre
Role: PRINCIPAL_INVESTIGATOR
Name: David R. Macdonald, MD, FRCPC
Affiliation: London Health Sciences Centre
Role: STUDY_CHAIR
Name: Glenn J. Lesser, MD
Affiliation: Wake Forest University Health Sciences
Role: STUDY_CHAIR
Name: Stephen W. Coons, MD
Affiliation: St. Joseph's Hospital and Medical Center, Phoenix
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
