Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver
Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver (SONAR: Surgery in Oligometastatic PaNcreatic CAnceR) a Randomized Controlled Trial
Azienda Ospedaliera di Padova
56 participants
Nov 6, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria8
- 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.)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (at enrollment)
- Partial response or stable disease after completion of first-line chemotherapy, as determined by RECIST 1.1 criteria21 (modified to exclude any % of increase in the sum of diameters of target lesions) (at enrollment).
- Decreasing or stable (defined as ≤20% increase) serum CA19-9 level after chemotherapy (at enrollment).
- Liver metastases considered resectable (see section 5) or alternatively treatable by needle ablation/microwave once no larger than 20 mm (at enrollment).
Exclusion Criteria11
- Locally advanced pancreatic cancer according to NCCN4.
- Unresectable liver disease (according to multidisciplinary discussion).
- Involvement of other organs.
- Presence of significant comorbidities precluding surgery.
- Pregnancy.
- Contraindications to surgical resection.
- Prior surgical resection of the primary tumor or liver metastases.
- Evidence of extrahepatic metastases.
- Inability to provide informed consent or participate in follow-up assessments.
- Disease progression as determined by RECIST 1.1 criteria21 (modified to include any % of increase in the sum of diameters of target lesions) after chemotherapy.
- Serum CA19-9 level increase \>20% after chemotherapy.
Interventions
Surgical 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06690528