Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples.
It is a prospective, randomized study in patients with metastatic colorectal carcinoma
progressing after two lines of prior therapy. Patients will be randomized (1:1) to receive
chemotherapy as determined by its oncologist or treatment according to chemosensitivity
profile obtained. For obtaining the profile a histological tumor sample and a sample of
venous blood in a tube with heparin standard are necessary . This latter sample will be
processed to isolate circulating tumor cells by cell adhesion with matrix coated glass
spheres. The RNA from these circulating tumor cells as well as from tumor cells of tumor
biopsies from the same patients will be extracted by a standard procedure for extracting RNA
for genetic expression analysis. Based on the analysis performed on tumor biopsy is
generated a ranked list of potentially more effective treatments in every case
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
To determine the tumor progression-free survival at 3 and 6 months (PFS3 and PFS6) in both groups of patients and identify whether there is a statistically significant difference
12 months
Yes
Carlos Gómez, M.D.,Ph.D
Study Director
Centro Nacional de Investigaciones Oncológicas (CNIO)
Spain: Spanish Agency of Medicines
CNIO-GI-01-2012
NCT01703910
November 2012
September 2013
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