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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Prophylactic Cranial Irradiation
Sponsored by
Instituto Nacional de Cancerologia de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Prophylactic Cranial Irradiation, Lung Cancer, Non Small Cell Lung Cancer, Carcinoembryonic Antigen

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Cancerología

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A Prophylactic Cranial Irradiation

B Observation Group

Arm Description

Patients will received PCI 25 Gy in 10 fractions WBRT 4 weeks after initial treatment in the absence of disease progression.

Patients in this arm will be observed (not receiving WBRT)

Outcomes

Primary Outcome Measures

Cumulative incidence of brain metastases
From the day of randomization to the date when brain metastasis develop if this is the case.

Secondary Outcome Measures

Overall Survival
From the day of randomization to the date of death if this is the case
Quality of life as per QLQ-C30
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
A mini mental status examination will be performed before, during and after PCI and will be compared with the observation group questionnaires

Full Information

First Posted
April 17, 2012
Last Updated
April 25, 2023
Sponsor
Instituto Nacional de Cancerologia de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01603849
Brief Title
Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis
Acronym
PCI
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancerologia de Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Prophylactic Cranial Irradiation, Lung Cancer, Non Small Cell Lung Cancer, Carcinoembryonic Antigen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A Prophylactic Cranial Irradiation
Arm Type
Experimental
Arm Description
Patients will received PCI 25 Gy in 10 fractions WBRT 4 weeks after initial treatment in the absence of disease progression.
Arm Title
B Observation Group
Arm Type
No Intervention
Arm Description
Patients in this arm will be observed (not receiving WBRT)
Intervention Type
Radiation
Intervention Name(s)
Prophylactic Cranial Irradiation
Intervention Description
Patients allocated to this arm will received treatment with whole brain radiotherapy 25 Gy in 10 fractions.
Primary Outcome Measure Information:
Title
Cumulative incidence of brain metastases
Description
From the day of randomization to the date when brain metastasis develop if this is the case.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
From the day of randomization to the date of death if this is the case
Time Frame
24 months
Title
Quality of life as per QLQ-C30
Description
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.
Time Frame
12 months
Title
Mental function
Description
A mini mental status examination will be performed before, during and after PCI and will be compared with the observation group questionnaires
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar MD Arrieta, MD
Organizational Affiliation
Instituto Nacional de Cancerologia, Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cancerología
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33640422
Citation
Arrieta O, Maldonado F, Turcott JG, Zatarain-Barron ZL, Barron F, Blake-Cerda M, Cabrera-Miranda LA, Cardona AF, de la Garza JG, Rosell R. Prophylactic Cranial Irradiation Reduces Brain Metastases and Improves Overall Survival in High-Risk Metastatic Non-Small Cell Lung Cancer Patients: A Randomized phase 2 Study (PRoT-BM trial). Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1442-1450. doi: 10.1016/j.ijrobp.2021.02.044. Epub 2021 Feb 25.
Results Reference
derived

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

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