The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
Time frame: 2 years
Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.
Time frame: 2 years
Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)
Time frame: 2 years
Overall Survival
Time frame: 2 years
Number of Participants Who Experienced Toxicity
Time frame: 2 years
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