Proteomic profile analysis to classify advanced pancreatic adenocarcinoma patients for clinical outcome after treatment with PDXG (cisplatin, docetaxel, capecitabine, gemcitabine) or PEXG (cisplatin, epirubicin, capecitabine, gemcitabine) regimen. - ND

• Conditions: patients affected by adenocarcinoma at stage III or IV who are candidate to receive upfront chemotherapy according to PDXG or PEXG regimen.; MedDRA version: 9.1Level: LLTClassification code 10052747Term: Adenocarcinoma pancreas

• Registration Number: EUCTR2009-013029-41-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

to include patients with cytological or histological diagnosis of pancreatic adenocarcinoma at stage III or IV who are candidate to receive upfront chemotherapy according to PDXG or PEXG regimen.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patients withouth cytological or histological diagnosis of pancreatic adenocarcinoma at stage III or IV who are candidate to receive upfront chemotherapy according to PDXG or PEXG regimen.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the predictive value of proteomic profiling on serum samples taken from patients with primary diagnosis of stage III and IV [15] advanced pancreatic adenocarcinoma who receive first-line chemotherapy with either PDXG (Cisplatin, Docetaxel, Gemcitabine, Capecitabine) or PEXG (Cisplatin, Epirubicin, Gemcitabine, Capecitabine) regimen.;Secondary Objective: Correlation of proteomic profiling with :<br>Overall Survival (OS) <br>Progression-free Survival (PFS)<br>Response Rate (RR)<br>Biomarkers (CA19.9) nadir response;Primary end point(s): to include patients with cytological or histological diagnosis of pancreatic adenocarcinoma at stage III or IV who are candidate to receive upfront chemotherapy according to PDXG or PEXG regimen.