About this trial
This study investigates the impact of surgical resection compared to palliative care in patients with oligometastatic pancreatic cancer limited to the liver. Specifically, it examines whether surgery after stable disease or response to chemotherapy can improve survival and quality of life. The international, multicenter randomized trial will recruit 56 patients, assigning them to either surgical resection (including tumor and liver metastases) or ongoing palliative care with chemotherapy. Stratification by performance status, tumor markers, and tumor location will ensure balanced study groups. Outcome assessments, conducted over a minimum two-year follow-up, include clinical evaluations, imaging, and quality-of-life metric
Eligibility criteria
Qualifiers
Adult patients aged ≥18 years and ≤75 years (at diagnosis).
Cytologically or histologically confirmed pancreatic adenocarcinoma either resectable or borderline resectable (at diagnosis) according to National Comprehensive Cancer Network (NCCN)4 (see section 5).
Synchronous oligometastatic disease (at diagnosis), defined as a limited number of radiologically documented liver metastases (up to 3 lesions).
No evidence of extrahepatic metastases (at diagnosis.)
Disqualifiers
Locally advanced pancreatic cancer according to NCCN4.
Unresectable liver disease (according to multidisciplinary discussion).
Involvement of other organs.
Presence of significant comorbidities precluding surgery.
Trial design
Treatments tested in this trial
- Surgical resection of both the primary tumor and liver metastases
Treatment groups
Sponsors and collaborators
Azienda Ospedaliera di Padova
Lead sponsor
University of Padova
Collaborator