Randomized to Assess the Efficacy of Whole Brain Radiation Therapy (WBRT) With Concomitant Gefitinib Followed by Maintenance Gefitinib, and Gefitinib Alone, in Lung Cancer Patients With Brain Metastasis
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the objective response rate of brain metastases in each arm
at 6 weeks
Yes
Antoine CARPENTIER, MD,PhD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health
P100601
NCT01363557
March 2012
March 2014
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