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

NCT06690528 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-11-15

No results posted yet for this study

Summary

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

  • Pancreatic Cancer Metastatic

Interventions

PROCEDURE

Surgical resection of both the primary tumor and liver metastases

Surgical resection of both the primary tumor and liver metastases. The surgical approach, extent of resection, and perioperative management will follow the standard protocols at each participating center. Venous vascular resections might be performed to reach radicality. Either standard or parenchyma sparing liver resections might be performed for resection of the liver metastases. Alternatively, needle ablation/microwave on the liver lesions is possible for lesions \<20 mm if technically feasible. Post-operative chemotherapy and/or radiotherapy could be administered as per multi-disciplinary decision based on case-by-case evaluation.

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER

  • Azienda Ospedaliera di Padova

    lead OTHER

Principal Investigators

  • Giovanni Marchegiani, MD, PhD, Professor · University of Padova

  • Umberto Cillo, Director, MD, Professor · University of Padova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06690528 on ClinicalTrials.gov