Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis (PCI)

April 25, 2023 updated by: Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional De Cancerologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with histologically proven advanced NSCLC (Stage IIIB or IV) including wild-type, EGFR-mutated or ALK-rearrangements who received treatment and were without progression at the end.
  • Above 18 years
  • General status with a Karnofsky >80%
  • Eastern Cooperative Group (ECOG) ≤2
  • Negative CNS MRI at the beginning of any treatment
  • Carcinoembryonic antigen > 20 pg
  • 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
  • Abnormal laboratory test that interfere with chemotherapy or TKI administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of brain metastases
Time Frame: 24 months
From the day of randomization to the date when brain metastasis develop if this is the case.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 24 months
From the day of randomization to the date of death if this is the case
24 months
Quality of life as per QLQ-C30
Time Frame: 12 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.
12 months
Mental function
Time Frame: 12 months
A mini mental status examination will be performed before, during and after PCI and will be compared with the observation group questionnaires
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Principal Investigator: Oscar MD Arrieta, MD, Instituto Nacional de Cancerologia, Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

May 20, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pciHighRiskINCAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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