RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.
OBJECTIVES: * Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database. * Determine the short- and long-term toxicity of this regimen in these patients. * Determine progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter study. * Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7 days a week, for 6 weeks. * Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Overall survival
Time frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
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 outcome analysis.
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Foundation for Cancer Research and Education
Phoenix, Arizona, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Saint Agnes Medical Center
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Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Radiological Associates of Sacramento Medical Group, Inc.
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Yale Comprehensive Cancer Center at Yale University School of Medicine
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CCOP - Christiana Care Health Services
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University of Florida Shands Cancer Center
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