Actively Recruiting
Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver
Led by Azienda Ospedaliera di Padova · Updated on 2024-11-15
56
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera di Padova
Lead Sponsor
U
University of Padova
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Confirmed pancreatic adenocarcinoma that is resectable or borderline resectable
- Synchronous oligometastatic disease with up to 3 liver metastases
- No evidence of metastases outside the liver
- ECOG performance status of 0 or 1 at enrollment
- Partial response or stable disease after first-line chemotherapy
- Stable or decreasing serum CA19-9 levels after chemotherapy
- Liver metastases that can be surgically removed or treated by needle ablation if under 20 mm
You will not qualify if you...
- Locally advanced pancreatic cancer
- Unresectable liver disease
- Involvement of other organs beyond the liver
- Significant health problems preventing surgery
- Pregnancy
- Contraindications to surgery
- Previous surgery to remove the primary tumor or liver metastases
- Metastases outside the liver
- Unable to give informed consent or participate in follow-up
- Disease progression after chemotherapy
- Serum CA19-9 levels increased by more than 20% after chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UOC Chirurgia Generale 2, Azienda Ospedale di Padova
Padova, Italy, Italy, 35128
Actively Recruiting
Research Team
G
Giovanni Marchegiani, Medical Doctor, PhD, Professor
CONTACT
G
Giampaolo Perri, Medical Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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