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
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.)
Locally advanced pancreatic cancer according to NCCN4.
Unresectable liver disease (according to multidisciplinary discussion).
Involvement of other organs.
Presence of significant comorbidities precluding surgery.
Parallel
Surgical resection of both the primary tumor and liver metastases
Procedure/SurgerySurgical resection of both the primary tumor and liver metastases. The surgical approach, extent of resection, and perioperative management will follow the standard protocols at each participating center. Venous vascular resections might be performed to reach radicality. Either standard or parenchyma sparing liver resections might be performed for resection of the liver metastases. Alternatively, needle ablation/microwave on the liver lesions is possible for lesions \<20 mm if technically feasible. Post-operative chemotherapy and/or radiotherapy could be administered as per multi-disciplinary decision based on case-by-case evaluation.
Two-year OS (2y-OS) rate
The percentage of patients alive after 2 years from randomization.
Progression Free Survival (PFS)
The time between randomization and diagnosis of progressive disease.
Surgical mortality and morbidity
Surgical mortality and morbidity, graded according to Clavien-Dindo classification, at 90-days after surgery.
Cancer Quality of Life (CQoL)
The EORTC QLQ-C30 is a quality-of-life assessment tool for cancer patients, comprising 30 items that cover physical, emotional, and social aspects of well-being. It includes 15 scales: 5 functional (physical, role, cognitive, emotional, social), 3 symptom (fatigue, nausea/vomiting, pain), 6 single-item symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial impact), and 1 global health scale. Responses use a scale from 1 to 4, except the global health scale, which ranges from 1 to 7. Scores are transformed to a 0-100 scale; for functional scales, higher scores mean better function, while in symptom scales, higher scores indicate more severe symptoms. This scoring enables monitoring of patient well-being and the impact of treatments.
Pancreatic Cancer Quality of Life (PQoL)
The EORTC QLQ-PAN26 is a quality-of-life assessment tool specifically developed for patients with pancreatic cancer, used alongside the core QLQ-C30 questionnaire. It includes 26 items focused on pancreatic cancer-related symptoms and treatment effects, covering domains such as pain, gastrointestinal symptoms, dietary changes, and emotional issues unique to this patient group. Scales include specific areas like pancreatic pain, digestive issues, altered bowel habits, and jaundice, as well as treatment side effects. Responses follow a 1 to 4 scale, with scores transformed to a 0-100 range; higher scores on symptom scales reflect more severe symptoms, while higher functional scale scores indicate better functioning. This questionnaire allows for targeted monitoring of pancreatic cancer patients' unique challenges and treatment impacts
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Azienda Ospedaliera di Padova
Lead sponsor
University of Padova
Collaborator
