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Clinical Trial Summary

The purpose of this study is to determine the proportion of patients alive after 12 months of the beginning of the trial in patients with advanced pancreatic carcinoma individually selected and grouped according to the expression in tumor tissue for therapeutic targets.


Clinical Trial Description

Phase II, open two branches, in which conventional treatment is administered to patients diagnosed with metastatic pancreatic carcinoma. Patients will be randomized (1:1) to a treatment arm or control arm of experimental treatment guided by the therapeutic targets. Patients in the control treatment arm will be treated with any of the schemes used in the study according to the discretion of the physician responsible. Patients will be analyzed as "intention to treat." In the experimental treatment arm (therapeutic targets) and within 15 days will determine the markers of therapeutic targets detailed in the protocol, either from pre-existing tumor sample or a fresh sample obtained by biopsy. Based on the results of this analysis, we prescribe a chemotherapy treatment determined for possible treatments currently used in pancreatic carcinoma, gemcitabine, gemcitabine and capecitabine, gemcitabine and erlotinib, FOLFIRINOX, FOLFOX, FOLFIRI.

Treatment duration is indefinite . ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01454180
Study type Interventional
Source Centro Nacional de Investigaciones Oncologicas CARLOS III
Contact
Status Completed
Phase Phase 2
Start date October 2011
Completion date December 2014

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