Overview

This trial is active, not recruiting.

Condition lung cancer
Treatment prophylactic cranial irradiation
Phase phase 2
Sponsor Instituto Nacional de Cancerologia de Mexico
Start date May 2012
End date June 2016
Trial size 128 participants
Trial identifier NCT01603849, pciAdenoINCAN

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will received PCI 25 Gy in 10 fractions WBRT 4 weeks after initial treatment in the absence of disease progression.
prophylactic cranial irradiation
Patients allocated to this arm will received treatment with whole brain radiotherapy 25 Gy in 10 fractions.
(No Intervention)
Patients in this arm will be observed (not receiving WBRT)

Primary Outcomes

Measure
Central Nervous System Progression Free Survival
time frame: 12 months

Secondary Outcomes

Measure
Overall Survival
time frame: 24 months
Quality of life
time frame: 24 months
Mental function
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Patients with histologically proven advanced NSCLC (Stage IIIB or IV) who received treatment either locoregional or systemic without progression at the end of it. - Above 18 years and under 60 years of age - General status with a Karnofsky >80% - Eastern Cooperative Group (ECOG) ≤2 - Negative CNS MRI at the beginning of any treatment - Carcinoembryonic antigen > 20 ng/mL - Hepatic and hematic cytology test within normal range - Adequate renal function - Those who accepted to participate in the study and who sign the letter of informed consent. Exclusion Criteria: - Patients with another type of cancer - Patients who refuse participate in the protocol - General status with a Karnofsky <80% - Eastern Cooperative Group (ECOG) >2 - Previous treatment with WBRT - Previous treatment with chemotherapy - Disease progression after initial treatment, either chemotherapy or chemoradiotherapy depending the case. - CNS metastasis at diagnosis - Carcinoembryonic antigen < 20 ng/mL - Abnormal laboratory test that interfere with chemotherapy administration

Additional Information

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
Principal investigator Oscar MD Arrieta, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Instituto Nacional de Cancerologia de Mexico.