Status:
SUSPENDED
IORT on Borderline Resectable Pancreatic Cancer
Lead Sponsor:
Universita di Verona
Conditions:
Borderline Resectable Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This phase II study investigates the efficacy of IORT for patients with borderline resectable pancreatic cancer. The purpose of the study is to investigate whether the addition of IORT, after FOLOFIRI...
Detailed Description
Treatment outcomes of borderline resectable pancreatic cancer are still poor even after completion of FOLFIRINOX-based chemotherapy and radical resection. A growing body of literature is demonstrating...
Eligibility Criteria
Inclusion
- • Biopsy-proven, previously untreated borderline resectable PC, defined according to the NCCN guidelines v1.2019;
- Age 18-80 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Adequate bone marrow function (absolute neutrophil count ≥1500 per cubic millimeter; platelet count ≥100.000 per cubic millimeter; hemoglobin level ≥10 g per deciliter), liver function (serum total bilirubin level ≤1.5 times the upper limit of the normal range), and renal function (creatinine clearance ≥50 ml per minute);
- Ability to understand the characteristics of the clinical trial;
- Written informed consent.
Exclusion
- • Ampullary, biliary, or duodenal adenocarcinoma; pancreatic adenocarcinoma in the background of an intraductal papillary mucinous neoplasia (IPMN), other uncommon pancreatic adenocarcinomas (acinar-cell, squamous, giant-cell osteoclastic-like);
- Invasive cancer in the last 5 years requiring radiation therapy to the upper abdomen or chemotherapy;
- Symptomatic heart failure or coronary artery disease;
- Pregnant or lactating women;
- Impaired mental state or language problems.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04090463
Start Date
October 1 2019
End Date
December 30 2027
Last Update
May 7 2024
Active Locations (1)
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1
General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital
Verona, Italy, 37134