Modulation of the immune response in patients with pancreatic tubular carcinoma - MIS-MIT

• Conditions: Pancreatic adenocarcinoma; after R0 or R1 resection and adjuvant gemcitabine treatment.; MedDRA version: 9.1Level: LLTClassification code 10052747Term: Adenocarcinoma pancreas; MedDRA version: 9.1Level: LLTClassification code 10065908Term: Cystadenocarcinoma pancreas

• Registration Number: EUCTR2008-006710-23-SI
• Lead Sponsor: Blood Transfusion Centre of Slovenia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. ECOG performace status 0, 1 or 2 at the time of randomization,
2. following R0 or R1 pancreatic tubular adenocarcinoma (larger than 2 centimeters) resection,
3. completed adjuvant gemcitabine chemotherapy.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. expected survival of less than three months,
2. R2 resection,
3. metastatic disease (M1 or N1).

Study & Design

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