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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Instituto Nacional de Cancerologia de Mexico
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT01603849
First received: April 17, 2012
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: Prophylactic Cranial Irradiation
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cancerologia de Mexico:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 128
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603849

Contacts
Contact: Oscar Arrieta, MD ogarrieta@gmail.com

Locations
Mexico
Instituto Nacional de Cancerología Recruiting
Mexico City, Mexico, 14080
Contact: Oscar Arrieta, MD       ogarrieta@gmail.com   
Principal Investigator: Oscar MD Arrieta, MD         
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Oscar MD Arrieta, MD Instituto Nacional de Cancerologia, Columbia
  More Information

No publications provided

Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, Head of Lung Cancer Clinic, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01603849     History of Changes
Other Study ID Numbers: pciAdenoINCAN
Study First Received: April 17, 2012
Last Updated: May 31, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Cancerologia de Mexico:
Prophylactic Cranial Irradiation
Lung Cancer
Non Small Cell Lung Cancer
Carcinoembryonic Antigen

Additional relevant MeSH terms:
Lung Neoplasms
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 16, 2014