Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAzienda Ospedaliera di Padova

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

56 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Azienda Ospedaliera di Padova

Lead sponsor

University of Padova

Collaborator