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||Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
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. [ Time Frame: Death of last follow-up. Analysis occurs after all patients have been potentially followed for 3 years ]
- Progression-free survival [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary analysis. ]
- Association of survival and progression-free survival with MGMT methylation status [ Time Frame: from randomization to date of progression, death or last follow-up. Analysis occurs after the primary outcome analysis. ]
- Quality of life [ Time Frame: From registration to one year. ]
- Neurocognitive function [ Time Frame: From registration to one year. ]
|Study Start Date:||January 2005|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Daily temozolomide, radiation therapy, temozolomide
Daily temozolomide plus concurrent radiotherapy (54 Gy/30 fractions/6 weeks) followed by temozolomide x 12 cycles
|Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114140
Show 47 Study Locations
|Principal Investigator:||Barbara J. Fisher, MD||London Health Sciences Centre|
|Study Chair:||David R. Macdonald, MD, FRCPC||London Health Sciences Centre|
|Study Chair:||Glenn J. Lesser, MD||Wake Forest University Health Sciences|
|Study Chair:||Stephen W. Coons, MD||St. Joseph's Hospital and Medical Center, Phoenix|