Actively Recruiting
Led by Azienda Ospedaliera di Padova · Updated on 2024-11-15
56
Participants Needed
1
Research Sites
N/A
Total Duration
A
Azienda Ospedaliera di Padova
Lead Sponsor
U
University of Padova
Collaborating Sponsor
This research investigates the role of surgical removal compared to palliative care in patients with pancreatic cancer that has spread to the liver but remains limited in number (oligometastatic). The study focuses on whether surgery after stable disease or a positive response to chemotherapy can improve survival and quality of life in these patients. This international, multicenter randomized controlled trial aims to provide clearer evidence on the best approach for managing this aggressive cancer stage. Participants will be randomly assigned to one of two groups. One group will have surgery to remove both the primary pancreatic tumor and liver metastases, with the surgical approach tailored by each center's protocols. Some liver lesions under 20 mm may be treated with needle ablation or microwave techniques. Postoperative chemotherapy or radiotherapy may be given based on individual cases. The other group will continue with palliative care, including observation or ongoing chemotherapy according to the physician's choice and prior treatment, following approved protocols. Throughout the study, participants will have regular clinical evaluations, lab tests, and imaging scans such as abdominal and chest CTs every 8-12 weeks. Quality of life and nutritional status will also be assessed. The primary outcome measured is survival two years after randomization, with secondary outcomes including progression-free survival, surgical complications, cancer-related quality of life, and treatment-related side effects. The minimum follow-up period is two years from enrollment.
CONDITIONS
Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing from randomization until disease progression or discontinuation, with a minimum follow-up of 2 years
Participants receive either surgical resection of the primary tumor and liver metastases with possible postoperative chemotherapy or radiotherapy, or continue with palliative care consisting of observation or continuation of chemotherapy based on the investigator's choice.
Visits every 8 to 12 weeks for clinical assessments, laboratory tests, imaging, quality-of-life, and nutritional evaluations
Duration - Up to 2 years from randomization
Participants are monitored for survival, disease progression, surgical outcomes, quality of life, and treatment-related adverse events for up to 2 years after randomization.
Visits every 8 to 12 weeks for assessments
Total: 1 location
1
UOC Chirurgia Generale 2, Azienda Ospedale di Padova
Padova, Italy, Italy, 35128
Actively Recruiting
G
Giovanni Marchegiani, Medical Doctor, PhD, Professor
G
Giampaolo Perri, Medical Doctor
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Riccardo Guastella, Giampaolo Perri, Domenico Bassi...
https://pubmed.ncbi.nlm.nih.gov/41526867