Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis (PCI)
|ClinicalTrials.gov Identifier: NCT01603849|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2012
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: Prophylactic Cranial Irradiation||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
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)
- Central Nervous System Progression Free Survival [ Time Frame: 12 months ]From the day of randomization to the date when brain metastasis develop if this is the case.
- Overall Survival [ Time Frame: 24 months ]From the day of randomization to the date of death if this is the case
- Quality of life [ Time Frame: 24 months ]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 ]a mini mental status examination will be performed before, during and after PCI and will be compared with the observation group questionnaires
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603849
|Instituto Nacional de Cancerología|
|Mexico City, Mexico, 14080|
|Principal Investigator:||Oscar MD Arrieta, MD||Instituto Nacional de Cancerologia, Columbia|