SuspendedPhase 2

IORT on Borderline Resectable Pancreatic Cancer

Stopped: Logistic and financial reasons

Italy100 participantsStarted 2019-10-01

Plain-language 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 FOLOFIRINOX-base chemotherapy, and SBRT, increases the 3-year survival rate. A total of 101 patients will be enrolled, and these patients will receive IORT of 10 to 20 Gy, according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • 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 Criteria: * • 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.

What they're measuring

Disease-specific survival

Timeframe: 36 months

Trial details

NCT IDNCT04090463

SponsorUniversita di Verona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-30