Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis (PCI)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis|
- Central Nervous System Progression Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]From the day of randomization to the date when brain metastasis develop if this is the case.
- Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]From the day of randomization to the date of death if this is the case
- Quality of life [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]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.
- Mental function [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]a mini mental status examination will be performed before, during and after PCI and will be compared with the observation group questionnaires
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: A Prophylactic Cranial Irradiation
Patients will received PCI 25 Gy in 10 fractions WBRT 4 weeks after initial treatment in the absence of disease progression.
Radiation: Prophylactic Cranial Irradiation
Patients allocated to this arm will received treatment with whole brain radiotherapy 25 Gy in 10 fractions.
No Intervention: B Observation Group
Patients in this arm will be observed (not receiving WBRT)
- To obtain a greater PFS and CNS PFS in patients with NSCLC treated with PCI after locoregional or systemic treatment.
- Evaluate the benefit in OS in the specific group of patients who are at increased risk of developing brain metastasis
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603849
|Instituto Nacional de Cancerología|
|Mexico City, Mexico, 14080|
|Principal Investigator:||Oscar MD Arrieta, MD||Instituto Nacional de Cancerologia, Columbia|