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

RecruitingPhase 2Ages 18 Years - 75 YearsAllAzienda Ospedaliera di Padova
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult patients aged โ‰ฅ18 years and โ‰ค75 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 โ‰ค20% 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 Criteria: * 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. Note: Additional specific exclusion criteria may be defined at each participating center based on their institutional guidelines and patient population.
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What it tests

  • Surgical resection of both the primary tumor and liver metastases
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Where

1 site
UOC Chirurgia Generale 2, Azienda Ospedale di Padova
Padova, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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