Metastatic Colon Cancer MedDRA version: 14.1 Level: PT Classification code 10009956 Term: Colon cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutic
Sponsors
Fundación Centro Nacional de Investigaciones Oncológicas Carlos III (CNIO)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the feasibility of establishing a susceptibility profile to treatment from histological tumor samples and tumor cells of colon isolated from peripheral blood through the tumor progression-free survival at 3 and 6 months (PFS 3 and PFS 6) in both treatment groups.;Primary end point(s): Determine progression-free survival at 3 months;Timepoint(s) of evaluation of this end point: - Until progression disease;Secondary Objective: - Evaluate the correlation between gene expression profiles obtained from the CTC and gene expression profiles - Characterize the different susceptibility profiles obtained from the analysis of gene expression and correlate with other known molecular-clinical parameters. - Determine the objective tumor responses obtained in both treatment groups. - Determine the overall survival obtained in both treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of patients with CTC detected - Number of patients with valid RNA isolation for assay (per quantity and per quality of RNA) - Number of patients with a final report with a recommended therapeutic treatment - Time spent since the sample taken to the RNA shipment for assay - Time spent since the sample taken to the final report with a recommended therapeutic treatment - Percentage of samples with correlation between the susceptibility profile obtained from tissue and the CTC result in blood sample. - Progression free survival - Objective Response Rate, following RECIST 1.1 criteria - Overall survival;Timepoint(s) of evaluation of this end point: 1. Until end of treatment 2. Until Death | — |
Countries
Spain
Contacts
Public ContactUnidad de Gestión Ensayos Clínicos
Fundación Centro Nacional de Investigaciones Oncológicas Carlos III (CNIO)
Outcome results
None listed