Status:
NOT_YET_RECRUITING
Surgery for Liver Metastases From PDAC
Lead Sponsor:
Linkoeping University
Collaborating Sponsors:
Lund University
Sahlgrenska University Hospital
Conditions:
Disseminated Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Dissemination from pancreatic ductal adenocarcinoma (PDAC) occurs in clinical practice either in the form of recurrence after initial treatment with curative intent resection (metachronous) or more fr...
Detailed Description
Dissemination from pancreatic ductal adenocarcinoma (PDAC) occurs in clinical practice either in the form of recurrence after initial treatment with curative intent or more frequently is manifested al...
Eligibility Criteria
Inclusion
- Confirmed PDAC with synchronous or metachronous dissemination isolated in the liver (primary cohort) or other dissemination as described in chapter 7.1. where the local tumour board find indication for curative treatment attempt.
- The confirmation of PDAC before chemotherapy is not regulated by the protocol but EUS guided biopsies directed to the primary tumour or a site of recurrence/dissemination is recommended whereas a percutaneous approach towards liver lesion(s) can be an alternative diagnostic approach; radiology and elevated serum tumor markers may guide diagnosis in exceptional cases, for which, e.g., pathological sampling fails.
- Metastases are defined as synchronous when liver tumors are detected simultaneously with the primary tumor or within the first 6 months thereafter. All other tumors are regarded as metachronous metastases or locally recurrent disease (when applicable).
- The same definition applies to localized lesions detected intra- as well as extra-abdominally.
- Patients treated due to the radiological appearance and or elevated CA-19.9 levels despite negative biopsies are accepted for inclusion into the study
- To be included in "Limited liver desease":
- Up to 4 liver metastases treatable with liver resections (without volume expansion of the future liver remnant)/thermal ablations/RFA/IRE (largest diameter \< 5 cm and for ablative techniques \< 2 cm).
- Age 18 years or older ECOG 0-1 Any resectable (including borderline resectable, but without need for arterial reconstruction) (before or after neoadjuvant treatment) PDAC Patient can understand verbal and written information
Exclusion
- Age less than 18 years ECOG \>2 Patient is not able to understand the verbal and written information Progression of tumor (RECIST 1.1) during or after chemotherapy Distant metastases outside the liver (applies only to the primary cohort) Other malignancy within 2 years, the prognosis of which may affect the evaluation of the therapeutic outcome.
- Major non-pancreatic surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery Uncontrolled (bacterial or fungal) infections Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments Uncontrolled angina pectoris; cardiac failure or clinically significant arrhythmias Continuous use of immunosuppressive agents (Corticoids are allowed) Neuropathy \>grade 1 (CTCAE, v 5.0) Pregnancy or breast feeding Patients (M/F) with reproductive potential not implementing adequate contraceptive measures Pre-defined need for arterial reconstruction to resect primary tumor
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05271110
Start Date
March 1 2022
End Date
March 1 2027
Last Update
March 8 2022
Active Locations (1)
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1
Linkoping University Hospital
Linköping, Sweden, 582 72