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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-013029-41-IT
Enrollment
Unknown
Registered
2009-06-11
Start date
2009-07-07
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 9.1 Level: LLT Classification code 10052747 Term: Adenocarcinoma pancreas

Interventions

Trade Name: CISPLATINO TEVA Pharmaceutical Form: Solution for injection INN or Proposed INN: Cisplatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Na

Sponsors

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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 : Overall Survival (OS) Progression-free Survival (PFS) Response Rate (RR) 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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026