Efficacy of PERT for PEI in Unresectable Pancreatic Cancer. (PERTseverance)
Unresectable Pancreatic Cancer
About this trial
This is an interventional treatment trial for Unresectable Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer. Tumour located in the head of the pancreas. Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS). Significant weight loss (≥5% of the usual body weight) at screening. Life expectancy of at least six months at screening. Signed informed consent to the study. Exclusion Criteria: Hypersensitivity to pancreatin of porcine origin or to any of the excipients. Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned. Patients already on PERT. Prior history of upper gastrointestinal or pancreatic surgery. Short life expectancy (shorter than 6 months). Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy). Patients in whom a pancreatic stent has been placed. Unsolved gastric outlet obstruction. Unwillingness to participate in the study. Inability to comply with the study visits and study protocol, whatever the reason.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Other
experimental arm
control arm
Creon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months post randomization.
Creon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks during the last 3 months post randomization.