Individual Therapy by Gene Expression for Colon Cancer Patients

Conditions: Metastatic Colon Cancer
MedDRA version: 14.1Level: PTClassification code 10009956Term: Colon cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-001307-20-ES

Lead Sponsor: Fundación Centro Nacional de Investigaciones Oncológicas Carlos III (CNIO)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

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