Patients with pancreatic carcinoma treated by pancreatoduodenectomy. MedDRA version: 21.0 Level: LLT Classification code 10033659 Term: Pancreatoduodenectomy System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Dociton 10 mg film-coated tablet
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Tod
Sponsors
University Hospital Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Patients planned for elective pancreatoduodenectomy · Patients eligible for perioperative therapy with propranolol / etodolac 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 53 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria
Exclusion criteria: · Prior / concurrent therapy with beta-blockers, Cox-2 inhibitors or Etodolac · Known allergies to beta-blockers, Cox-2 inhibitors or Etodolac · Patients with a known long-term medication that may cause severe interactions with propranolol / etodolac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is assessment of safety for the perioperative use of propranolol and etodolac in patients with resectable cancer of the pancreatic head planned for elective pancreatoduodenectomy.;Secondary Objective: The secondary objectives of the trial are to assess feasibility and to generate first efficacy data for the perioperative use of propranolol and etodolac in patients with resectable cancer of the pancreatic head planned for elective pancreatoduodenectomy.;Primary end point(s): Safety endpoints: • Rates of severe adverse events and severe adverse drug reactions • Mortality at 30 and 90 days postoperatively • Pancreas-associated morbidity (pancreatic fistula, delayed gastric emptying, postoperative pancreatic hemorrhage, biliary leakage, fluid collection/abscess) ;Timepoint(s) of evaluation of this end point: Visit 2: one day before Operation Visit 3: day of surgery Visit 4: post-operative day (POD) 1 Visit 5: POD 3 Visit 6: POD 5 Visit 7 and 8: POD 7 or 14 (or day of discharge) Visit 9: POD 30 Follow-up will be 3 months for safety endpoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Feasibility endpoints: •Adherence to study medication •Completion of adjuvant chemotherapy Oncologic endpoints: •Overall survival •Disease-free survival •Rates of local / distant recurrence Biological endpoints/Biomarkers (will be measured at different timepoints of study conduct): •Blood samples: c-reactive protein (CRP), albumin, differential blood count, CA 19-9, carcinoembryonic antigen (CEA), cytokine multiplex, PGE-2 levels, circulating tumor cells, RNA sequencing in periphery blood cells (leukocytes) •Tissue samples: COX-2 expression, PGE-2 levels, immune cell infiltrate (immunehistochemistry), RNA sequencing of bulk tissue or of sorted tumor and stromal cells. ;Timepoint(s) of evaluation of this end point: Visit 1: screening Visit 2: one day before Operation Visit 3: day of surgery Visit 4: post-operative day (POD) 1 Visit 5: POD 3 Visit 6: POD 5 Visit 7 and 8: POD 7 or 14 (or day of discharge) Visit 9: POD 30 Visit 10: POD 3 months Visit 11: POD 6 months Visit 12: POD 12 months Visit 13: POD 24 months | — |
Countries
Germany
Contacts
Public ContactSDGC
Study Center of the German Surgical Society
Outcome results
None listed