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Trial Title:
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
NCT ID:
NCT06099119
Condition:
Unresectable Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Pancrelipase
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
creon 35.000 Ph.U (R)
Description:
Experimental arm: Pancreatic Exocrine Replacement Therapy (PERT) treatment during the six
months study period.
Arm group label:
experimental arm
Intervention type:
Other
Intervention name:
Best Standarard of Care
Description:
Control arm: no treatment over 3 months from randomization. PERT from third month untill
last visit in sixt month
Arm group label:
control arm
Other name:
creon 35.000 Ph.U (R)
Summary:
- This will a be an open label, multicentre, randomized, controlled study in patients
with unresectable pancreatic cancer, locally advanced or metastatic, with
significant weight loss, and the tumour located in the head of the pancreas
associated with dilated main pancreatic duct. Pancreatic Exocrine Replacement
Therapy (PERT) in these patients will be given on top of other required therapies
(best standard of care, BSC), including oncologic therapies, diabetes mellitus
therapies and acid suppressants and nutritional support as appropriate. The duration
of the study will be up to six months.
Consecutive patients meeting inclusion criteria and none of the exclusion criteria will
be evaluated for the study. Those patients signing the informed consent for study
participation will be randomized to one of the following two arms:
- The experimental arm will receive the best standard of care (BSC) and PERT (capsules
containing pancreatin 35,000 Ph.U.) at a fixed dose of 3 capsules with main meals
(breakfast, lunch and dinner) and 2 capsules with snacks over 6 months.
- The control arm will receive the BSC over 3 months, followed by a further 3-month
open uncontrolled phase of BSC + PERT at the dose mentioned above.
All patients will receive in addition a proton pump inhibitor (PPI) bid (any PPI at
standard dose is acceptable -omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg,
rabeprazole 20 mg, esomeprazole 40 mg) while on PERT, 20-30 minutes before breakfast and
dinner.
To make the two arms comparable, patients will be stratified in two groups (locally
advanced and metastatic pancreatic cancer) for randomization using computer generated
random numbers.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic
cancer.
2. Tumour located in the head of the pancreas.
3. Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS).
4. Significant weight loss (≥5% of the usual body weight) at screening.
5. Life expectancy of at least six months at screening.
6. Signed informed consent to the study.
Exclusion Criteria:
1. Hypersensitivity to pancreatin of porcine origin or to any of the excipients.
2. Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned.
3. Patients already on PERT.
4. Prior history of upper gastrointestinal or pancreatic surgery.
5. Short life expectancy (shorter than 6 months).
6. Patients on second line or beyond chemotherapy (those who failed with first line
chemotherapy therapy).
7. Patients in whom a pancreatic stent has been placed.
8. Unsolved gastric outlet obstruction.
9. Unwillingness to participate in the study.
10. Inability to comply with the study visits and study protocol, whatever the reason.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Hospital Clinico Universitario de Santiago
Agency class:
Other
Collaborator:
Agency:
Complejo Hospitalario de Navarra
Agency class:
Other
Collaborator:
Agency:
Karolinska Institutet
Agency class:
Other
Collaborator:
Agency:
San Raffaele University Hospital, Italy
Agency class:
Other
Collaborator:
Agency:
Beaujon Hospital
Agency class:
Other
Source:
Hospital Clinico Universitario de Santiago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06099119
