RecruitingPhase 2NCT06690528

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

Sponsor

Azienda Ospedaliera di Padova

Enrollment

56 participants

Start Date

Nov 6, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Metastatic

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for people with pancreatic cancer that has spread to a small number of spots in the liver (called oligometastatic disease): conversion surgery (trying to remove the cancer after it responds to chemotherapy) versus continuing with palliative care alone. It aims to find out if selected patients might benefit from surgery even when the cancer has spread. **You may be eligible if...** - You are 18–75 years old - You have confirmed pancreatic adenocarcinoma that is resectable or borderline resectable at diagnosis - You have up to 3 liver metastases (spots in the liver) confirmed on scans at diagnosis, with no other spread outside the liver - You are in good enough health to tolerate surgery and chemotherapy **You may NOT be eligible if...** - Your cancer has spread beyond the liver - You have more than 3 liver metastases - You are not well enough for surgery or intensive treatment - You have had prior treatment for pancreatic cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgical resection of both the primary tumor and liver metastases

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)

UOC Chirurgia Generale 2, Azienda Ospedale di Padova

Padova, Italy, Italy

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NCT06690528

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