NCT02782182

Perioperative FOLFIRINOX for Patients With Resectable Pancreatic Adenocarcinoma: A Pilot Study

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see whether it is possible to give 8 doses of a combination of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be removed with surgery.

Detailed description

Primary Objective: To evaluate the percentage of pancreatic cancer patients able to complete the full 4 months of preoperative chemotherapy and undergo a resection. Secondary Objectives * To assess the percentage of patients able to complete all therapy, including preoperative chemotherapy, surgery, and postoperative therapy. * To assess treatment-related toxicity during preoperative therapy * To assess intra-operative and post-operative complications * To assess the histopathologic (R0/R1) resection rate after preoperative therapy * To determine disease free survival (DFS) for patients who undergo resection. * To determine progression free survival (PFS) for all patients * To determine overall survival (OS) from the date of first treatment

Conditions

• Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

Type	Name	Description
DRUG	FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)	FOLFIRINOX administered preoperatively and postoperatively

Timeline

• Start date: 2016-06-28
• Primary completion: 2018-03-29
• Completion: 2018-03-29
• First posted: 2016-05-25
• Last updated: 2019-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study