Locally advanced pancreatic cancer MedDRA version: 21.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: fluorouracil
CAS Number: 51-21-8
Other descriptive name: FLUOROURACIL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration ty
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • LAPC (Karolinska Type B, C or D1). • Cytologically or histologically verified adenocarcinoma/carcinoma • The patient is operable (i.e. no co-morbidity which can preclude anaesthesia or sur-gery). • No sign of M1 disease. • WHO performance status 0-1. • Age = 18 years. • Adequate hematological, renal, and hepatic function: WBC > 3.0 x 109/l, platelets > 100 x 109/l, creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: • No prior radiotherapy to abdominal cavity. • No pregnancy or breast-feeding. Fertile patients must use adequate contraceptives. • No sign of other severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months). • No prior chemotherapy for PC. • No prior chemotherapy or other oncologic therapy within 12 months. • No contraindications towards FOLFIRINOX.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives: Quality of Life (EORTC QLQ-PAN26) PFS OS Response rate (RECIST v1.1) Histological tumor regression (TRG) Adverse events grade 2-5 (NCI-CTCAE 4.0) Surgical complications, including IRE (Clavien) Number of patients with progression during chemotherapy Number of patients with R0 resection Evaluation of biomarkers ;Primary end point(s): 2 year survival for all patients starting chemotherapy;Timepoint(s) of evaluation of this end point: Target recruitment period is estimated to be 12 months and follow-up period/end date is estimated to be one year from last infusion. ;Main Objective: Primary objective: 1.2 year survival for all patients starting chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of Life (EORTC QLQ-PAN26) PFS OS Response rate (RECIST v1.1) Histological tumor regression (TRG) Adverse events grade 2-5 (NCI-CTCAE 4.0) Surgical complications, including IRE (Clavien) Number of patients with progression during chemotherapy Number of patients with R0 resection ;Timepoint(s) of evaluation of this end point: Target recruitment period is estimated to be 12 months and follow-up period/end date is estimated to be one year from last infusion. | — |
Countries
Denmark
Contacts
Public ContactPer Pfeiffer
Odense University Hospital
Outcome results
None listed