Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis
1. To obtain a greater PFS and CNS PFS in patients with NSCLC treated with PCI after
locoregional or systemic treatment.
2. Evaluate the benefit in OS in the specific group of patients who are at increased risk
of developing brain metastasis
3. Evaluate quality of life and mental function before and after treatment with PCI and
compare it with patients in the observation group.
Methods: One hundred and twenty eight patients with locally advanced or metastatic (except
CNS metastasis) NSCLC will be included and randomized to receive either observation or PCI
25 Gy in 10 fractions Whole Brain Radiotherapy (WBRT) once the initial treatment has been
completed and progression of the disease ruled out.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Central Nervous System Progression Free Survival
From the day of randomization to the date when brain metastasis develop if this is the case.
Oscar MD Arrieta, MD
Instituto Nacional de Cancerologia, Columbia
Mexico: Ethics Committee