Temozolomide and Radiation Therapy in Treating Patients With Gliomas
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Drug: TemozolomideRadiation: Radiation therapy
- Registration Number
- NCT00114140
- Lead Sponsor
- Radiation Therapy Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Temozolomide + Radiation Therapy (RT) Radiation therapy Daily temozolomide plus concurrent radiotherapy followed by temozolomide Temozolomide + Radiation Therapy (RT) Temozolomide Daily temozolomide plus concurrent radiotherapy followed by temozolomide
- Primary Outcome Measures
Name Time Method Neurocognitive Function Baseline, 6 months, and 12 months. Hopkins Verbal Learning Test (HVLT) is a test measuring learning memory retrieval, and memory consolidation processes.; Controlled Oral Word Association Test (COWAT) is a test of phonemic verbal fluency. The patient produces as many words as possible in 1 min. (each) for a specific letter (C, F, L or P, R, W).; Trail Making Test (TMT) is a measure of visuospatial scanning, attention, sequencing, and speed in Part A (TMT A) and executive function in Part B (TMT B). Patients must "connect the dots" either in a numbered sequence or alternating letters and numbers. Difference between pre-treatment baseline and follow-up assessment scores determined by the reliable change (RC) index, using a 90% confidence interval to designate statistically significant change.
Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status Registration to 3 years Survival time is defined as time from registration to date of death from any cause. Progressive Disease (PD) is defined as 25% or \> increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Survival and progression-free survival are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Overall Survival Rate at 3 Years Registration to 3 years Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 3 years.
Progression-free Survival From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years. Progressive Disease (PD) is defined as 25% or \> increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Progression-free survival time is defined as time from registration to date of progressive disease or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Median survival time is reported.
Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) Baseline, 6 months, and 12 months. Functional Assessment of Cancer Therapy Scale with brain module (FACT-BR): a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions totalling 0-28), social/family well-being (7 questions totalling 0-28), emotional well-being (6 questions totalling 0-24), functional well-being (7 questions totalling 0-28) and brain cancer subscale which contains concerns relevant to patients with brain tumors (19 questions totalling 0-76). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 multiplied by the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total (0-184) is obtained by adding all domains together if the overall question response rate is greater than 80%.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Integrated Community Oncology Network
🇺🇸Jacksonville Beach, Florida, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, 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
Arizona Oncology Services Foundation
🇺🇸Phoenix, Arizona, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Aultman Cancer Center at Aultman Hospital
🇺🇸Canton, Ohio, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
🇺🇸Salem, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Gundersen Lutheran Center for Cancer and Blood
🇺🇸La Crosse, Wisconsin, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Cancer Treatment Center
🇺🇸Wooster, Ohio, 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
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Florida Cancer Center - Palatka
🇺🇸Palatka, Florida, United States
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Integrated Community Oncology Network at Southside Cancer Center
🇺🇸Jacksonville, Florida, United States
Integrated Community Oncology Network - Orange Park
🇺🇸Orange Park, Florida, United States
Flagler Cancer Center
🇺🇸Saint Augustine, Florida, United States
Baptist Medical Center South
🇺🇸Jacksonville, Florida, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States