A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)

NCT03483038 Phase 2 ACTIVE_NOT_RECRUITING Results posted

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Details

Lead sponsor	University of Florida
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	45
Start date	2018-12-13
Completion	2026-12

Conditions

• Pancreatic Adenocarcinoma

Interventions

• Liposomal Irinotecan
• FOLFOX regimen

Primary outcomes

• Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery — 30 days
  To determine the percentage of subjects who had post-operative complications 30 days post-surgery. Post-operative complications considered for this outcome measure included hospital readmission, death, second surgery or interventional procedure, or major complications extending hospital stay.

Countries

United States