Temozolomide and Radiation Therapy in Treating Patients With Gliomas
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.
Brain and Central Nervous System Tumors
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas|
- Overall survival at 3 years [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity rate [ Designated as safety issue: Yes ]
- Association of survival and progression-free survival with MGMT methylation status [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Neurocognitive function [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
- 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 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.
Show 47 Study Locations
|Study Chair:||Barbara J. Fisher, MD||London Regional Cancer Program at London Health Sciences Centre|
|Investigator:||David R. Macdonald, MD, FRCPC||London Regional Cancer Program at London Health Sciences Centre|
|Investigator:||Glenn J. Lesser, MD||Comprehensive Cancer Center of Wake Forest University|
|Investigator:||Stephen W. Coons, MD||St. Joseph's Hospital and Medical Center, Phoenix|