Comparing surgery and palliative care for liver metastases in pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether surgical resection of the primary tumor and liver metastases can improve survival and quality of life compared to palliative care in patients with oligometastatic pancreatic cancer. It focuses on patients who have stable disease or a response to chemotherapy and are eligible for surgery. The trial is an international, multicenter randomized study that will recruit 56 patients, assigning them to either the surgical group or the palliative care group. Outcome assessments will include clinical evaluations, imaging, and quality-of-life metrics over a minimum two-year follow-up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 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.

Where it's running

• UOC Chirurgia Generale 2, Azienda Ospedale di Padova
  Padova, Italy, Italy Recruiting

Study contacts

• Principal investigator: Umberto Cillo, Director, MD, Professor — University of Padova
• Study coordinator: Giovanni Marchegiani, Medical Doctor, PhD, Professor
• Email: giovanni.marchegiani@unipd.it
• Phone: +390498212259

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.