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Brief Title: A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma
Official Title: 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)
Study ID: NCT03483038
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Florida, Gainesville, Florida, United States
Orlando Health UF Health Cancer Center, Orlando, Florida, United States
Tallahassee Memorial Health Care, Tallahassee, Florida, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Name: Thomas George, MD
Affiliation: University of Florida
Role: PRINCIPAL_INVESTIGATOR