Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis (PCI)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
First received: April 17, 2012
Last updated: February 22, 2016
Last verified: February 2016
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.
Radiation: Prophylactic Cranial Irradiation
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2016 (Final data collection date for primary outcome measure)
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)
- 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.
|Ages Eligible for Study:
||18 Years to 60 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
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
|Instituto Nacional de Cancerología
|Mexico City, Mexico, 14080 |
Instituto Nacional de Cancerologia de Mexico
||Oscar MD Arrieta, MD
||Instituto Nacional de Cancerologia, Columbia
||Oscar Gerardo Arrieta Rodríguez MD, Head of Lung Cancer Clinic, Instituto Nacional de Cancerologia de Mexico
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 17, 2012
||February 22, 2016
||Mexico: Ethics Committee
Keywords provided by Instituto Nacional de Cancerologia de Mexico:
Prophylactic Cranial Irradiation
Non Small Cell Lung Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 27, 2016
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type