Ensayo Fase II de selección Individualizada Del Tratamiento de Quimioterapia en Pacientes Con Carcinoma de páncreas Avanzado en función de la determinación de Dianas terapéuticas en el Tejido Tumoral
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 .
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is survival as measured from the start of treatment the patient to the death of the patient according to the Kaplan-Meier. For each treatment arm will determine the overall survival and the survival and actuarial survival at one year
Manuel Hidalgo, M.D.,PhD
Spain: Spanish Agency of Medicines