Study Phase: Phase 2 Trial
Study Objetives:
* Primary end-point. Proportion of patients alive after 12 months in patients with advanced pancreatic carcinoma individually selected and grouped according to the expression in tumor tissue for therapeutic targets.
* Secondary end-points. 1. Assessing the feasibility of the method of patient-treatment-selection based on tumor tissue expression of therapeutic targets. 2. Overal survival comparison between Gemcitabine single agent treatment and the rest of chemotherapy schedules. 3. Determination of progression-free survival for each treatment group. 4. Determination of toxicity in all the patients.
Study population and Number of subject: A total of 60 pancreatic cancer patients with advanced pancreas cancer with no previous systemic treatment are expected to be enrolled.
Study design and schedule. Patients will be randomized (1:1) to a control arm or an experimental treatment arm guided by therapeutic targets. In the control arm, patients are treated with conventional chemotherapy regimens at the discretion of the investigator. In the experimental arm, patients are treated as determined in tumor tissue available for biomarker TS, TP, ERCC-1, Topo-1, K-Ras mutation and EGFR FISH, choosing FOLFIRINOX schemas, FOLFOX, FOLFIRI, Gemcitabine-Capecitabine Gemcitabine-Erlotinib, Gemcitabine single agent. All patients will be analyzed by intention to treat
