Know Cancer

or
forgot password

Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado


N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado


Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR
mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma


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 agent.

- Severe comorbidity.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Tumoral Response (RECIST criteria)

Principal Investigator

Rafael Rosell, Phd

Investigator Role:

Study Chair

Investigator Affiliation:

ICO-HOSPITAL GERMANS TRIAS I PUJOL

Authority:

Spain: Comité Ético de Investigación Clínica

Study ID:

SLAT

NCT ID:

NCT00883480

Start Date:

June 2005

Completion Date:

November 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location