Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally advanced or metastatic disease. Important to mention the number of patients that progress or recur in central nervous system (CNS). It has been reported that patients with adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (CEA) are in the highest risk to develop brain metastasis. In small cell lung cancer, treatment with prophylactic cranial irradiation (PCI) is the standard of care in patients without progression after locoregional or systemic treatment because the proven benefit in overall survival (OS) and progression free survival (PFS). However, in NSCLC PCI has not been able to prove any survival benefit, only in CNS PFS, probably because there is no trial, to our knowledge, of PCI in NSCLC that include only the specific group of patients considered in high risk of developing brain metastasis.
Objectives: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Patients allocated to this arm will received treatment with whole brain radiotherapy 25 Gy in 10 fractions.
Instituto Nacional de Cancerología
Mexico City, Mexico
Cumulative incidence of brain metastases
From the day of randomization to the date when brain metastasis develop if this is the case.
Time frame: 24 months
Overall Survival
From the day of randomization to the date of death if this is the case
Time frame: 24 months
Quality of life as per QLQ-C30
a QLQ questionnaire from EORTC organization (spanish version) will be performed before, during and after PCI and will be compared with the observation group questionnaires.
Time frame: 12 months
Mental function
A mini mental status examination will be performed before, during and after PCI and will be compared with the observation group questionnaires
Time frame: 12 months
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