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Completed

NCT Number: NCT01603849

Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma 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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Cancerología

Mexico City, 14080, Mexico

About this study

Objectives:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic Cranial Irradiation

Radiation

Patients allocated to this arm will received treatment with whole brain radiotherapy 25 Gy in 10 fractions.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall Survival

    Time frame: 24 months

    From the day of randomization to the date of death if this is the case

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia de Mexico

Other

Registry information

Official study 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

Acronym: PCI

Important dates

Study start
2012
Primary completion
2019
Study completion
2020
First posted
May 23, 2012
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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