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A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer.
OBJECTIVES: Primary * Determine the intracranial response rate in patients with brain metastasis secondary to non-small cell lung cancer treated with whole brain radiotherapy and temozolomide. Secondary * Determine the time to radiological progression in patients treated with this regimen. * Determine the time to neurological progression (confirmed by magnetic resonance imaging (MRI)) in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients undergo whole brain radiotherapy once daily, 5 days a week, for 2 weeks (10 fractions). Patients also receive concurrent oral temozolomide once daily on days 1-14. Beginning 3 weeks after the completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of neurologic (Central Nervous System, CNS) progression or unacceptable toxicity. Patients were followed every 3 months for 2 years. ACCRUAL: A total of 26 patients were accrued for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
December 20, 2005
Primary Completion Date
August 1, 2008
Completion Date
February 1, 2009
Last Updated
June 29, 2023
26
ACTUAL participants
Temozolomide
DRUG
Radiation therapy
RADIATION
Lead Sponsor
Eastern Cooperative Oncology Group
Collaborators
NCT05692635
NCT06066138
Data Source & Attribution
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