NCT01603849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

7.6 years

First QC Date

April 17, 2012

Last Update Submit

April 25, 2023

Conditions

Lung Cancer

Keywords

Prophylactic Cranial IrradiationLung CancerNon Small Cell Lung CancerCarcinoembryonic Antigen

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of brain metastases

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

    24 months

Secondary Outcomes (3)

  • Overall Survival

    24 months

  • Quality of life as per QLQ-C30

    12 months

  • Mental function

    12 months

Study Arms (2)

A Prophylactic Cranial Irradiation

EXPERIMENTAL

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

B Observation Group

NO INTERVENTION

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

Interventions

Prophylactic Cranial IrradiationRADIATION

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

A Prophylactic Cranial Irradiation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cancerología

Mexico City, 14080, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 33640422DERIVED

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Oscar MD Arrieta, MD

    Instituto Nacional de Cancerologia, Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Lung Cancer Clinic

Study Record Dates

First Submitted

April 17, 2012

First Posted

May 23, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)