Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR.
Lung cancer patients with newly diagnosed CNS metastasis with- at least one brain lesion measuring \> 1 cm in longest dimension - not eligible for surgery or stereotactic radio-surgeryOpen-label, multicentre, national, randomised (1:1) phase II trialArm A: WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance Arm B: Gefitinib
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
External beam RT using a total dose of 30 Gy with ten daily fractions of 3.0 Gy given 5 days per week over 2 weeks + Gefitinib 250 mg/day
250 mg/day
Service de Neurologie - Hôpital Avicenne
Bobigny, France
To assess the objective response rate of brain metastases in each arm
Time frame: at 6 weeks
Number of Participants with neurological Adverse Events
Time frame: at 6 weeks, 3 months, 4.5 months and 6 months
Progression-free survival (PFS)
Time frame: at 6 months
Overall survival
Time frame: at 6 months
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