Resectable pancreatic cancer MedDRA version: 18.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Oxaliplatin
Product Name: Oxaliplatin
Pharmaceutical Form: Infusion
Trade Name: Irinotecan
Product Name: Irinotecan
Pharmaceutical Form: Infusion
Trade Name: Fluorouracil
Product Name: F
Sponsors
Norwegian Gastointestinal Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Resectable pancreatic cancer Performance status 0-2 Histologically confirmed diagnosis 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Metastatic disease Non-resectable primary pancreatic cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall survival 1 year after surgery;Secondary Objective: Disease free survival (DFS) Number of positive lymph nodes in surgical specimen Resection margin (RO);Primary end point(s): Overall survival 1 year after surgery;Timepoint(s) of evaluation of this end point: 1 year after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease free survival (DFS) Number of positive lymph nodes in surgical specimen Resection margin (RO);Timepoint(s) of evaluation of this end point: CT scans 3, 6 and 12 months after surgery | — |
Countries
Norway
Contacts
Public ContactSvein Dueland
Oslo University Hospital
Outcome results
None listed