Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 E… (NCT00883480) | Clinical Trial Compass
CompletedNot Applicable
Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma
Spain153 participantsStarted 2005-06
Plain-language summary
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor ag…
What they're measuring
1
Tumoral Response (RECIST criteria)
Timeframe: From date of end of experimental treatment until the date of last follow up, assessed up to 24 months]