Status:
COMPLETED
Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma
Lead Sponsor:
Spanish Lung Cancer Group
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Detailed Description
Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma
Eligibility Criteria
Inclusion
- Patients age 18 years or more.
- Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).
- Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
- Tumor sample available.
- A measurable lesion, as defined by RECIST criteria.
- Karnofsky score 60% or more (ECOG \< 2).
- Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment.
- Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
- Patients with hepatical, renal and hematology normality values.
- Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
- Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
- Patients must be available for clinical follow-up..
Exclusion
- Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
- Severe comorbidity.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00883480
Start Date
June 1 2005
End Date
November 1 2008
Last Update
June 13 2022
Active Locations (2)
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1
Ico-Hospital Universitarios Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Carlos Haya
Málaga, Spain