Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis
18 Years
60 Years
Both
Lung Cancer
Trial Information
Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Central Nervous System Progression Free Survival
Outcome Description:
From the day of randomization to the date when brain metastasis develop if this is the case.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Oscar MD Arrieta, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Instituto Nacional de Cancerologia, Columbia
Authority:
Mexico: Ethics Committee
Study ID:
pciAdenoINCAN
NCT ID:
NCT01603849
Start Date:
May 2012
Completion Date:
May 2015
Related Keywords:
- Lung Cancer
- Prophylactic Cranial Irradiation
- Lung Cancer
- Non Small Cell Lung Cancer
- Carcinoembryonic Antigen
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Lung Neoplasms
- Neoplasm Metastasis
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