Comparing surgery and palliative care for liver metastases in pancreatic cancer
Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver (SONAR: Surgery in Oligometastatic PaNcreatic CAnceR) a Randomized Controlled Trial
This study is testing if surgery to remove both the main pancreatic tumor and liver metastases can help people with pancreatic cancer live longer and feel better compared to just receiving palliative care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera di Padova Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Padova, Italy) |
| Trial ID | NCT06690528 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with oligometastatic pancreatic adenocarcinoma limited to the liver and stable disease or response after first-line chemotherapy.
Not a fit: Patients with extrahepatic metastases or those not responding to initial chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for patients with oligometastatic pancreatic cancer.
How similar studies have performed: Other studies have explored surgical interventions for oligometastatic pancreatic cancer, but this specific approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Padova, Italy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.