Selection of Individualize Therapy in Metastatic Colon Cancer Patients According to the Genome Expression Profile in Tumor Samples.

Fundación Centro Nacional de Investigaciones Oncológicas Carlos III (CNIO)0 sitesMay 10, 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Fundación Centro Nacional de Investigaciones Oncológicas Carlos III (CNIO)
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

May 10, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundación Centro Nacional de Investigaciones Oncológicas Carlos III (CNIO)

•1\. Pathologic diagnosis of metastatic colon cancer.
•2\. Aged over 18 years
•3\. Measurable disease (RECIST 1\.1\)
•4\. Life expectation over 3 months, investigator criteria
•5\. Performace status ECOG (0\-1\)
•6\. Candidate for systemic therapy based on drug susceptibility profile determined by the genetic analysis of the tumor sample. Patients must have received at least 2 lines of standard treatment, including therapies antiEGFR in cases of tumors with Kras oncogene and b\-Raf native (non\-mutated)
•7\. Possibility for tumor biopsy to allow the correlation between RNA expression profile with that obtained from peripheral blood CTCs
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\. Patient received systemic treatment for cancer within two weeks prior to extraction of the blood sample.
•2\. Patient received therapeutic radioisotopes such as strontium 89 in a period of ? 4 weeks before blood collection.
•3\. Patient has undergone major surgery or percutaneous procedures such as placement of central venous catheter within ? 2 weeks before blood collection
•4\. Patient has been preceded by bone marrow transplantation and / or stem cell transplant
•5\. Patients with inability to oral drug delivery, either by preventing gastrointestinal administration situation or severe impairment of intestinal absorption
•6\. Any medical or psychiatric condition that might limit patient's ability to understand and comply with all study requirements, according to the investigator.
•7\. Pregnant or lactating women