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Brief Title: Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma
Official Title: Perioperative Irinotecan Combined With Oxaliplatin and 5-Fluoracil/Folinic Acid (FOLFIRINOX) For Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC): A Phase II, Open-Label, Single Arm Trial
Study ID: NCT06122480
Brief Summary: This is a Phase II, Open-Label, Single Arm trial investigating the outcomes of neoadjuvant FOLFIRINOX chemotherapy in patients with hepatic or pulmonary oligometastatic pancreatic adenocarcinoma.
Detailed Description: This clinical trial aims to evaluate the effectiveness and safety of neoadjuvant FOLFIRINOX chemotherapy in patients with hepatic or pulmonary oligometastatic pancreatic adenocarcinoma. FOLFIRINOX is administered in 14-day cycles following a specific treatment protocol. The primary goal is to assess treatment effectiveness, with secondary objectives including evaluating safety, impact on patients' health-related quality of life (HR-QoL), and analyzing the tumor microenvironment in organ-specific metastases of pancreatic cancer. An exploratory objective involves analyzing overall survival while considering HR-QoL in patients enrolled in a separate Institutional Review Board protocol for quality of life assessment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Johns Hopkins Hospital, Baltimore, Maryland, United States
Name: Jin He, MD, PhD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR