Neoadjuvant Modified FOLFIRINOX in Borderline Resectable Pancreatic Cancer
NCT02749136 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2019-11-25
Summary
The purpose of this study is to assess the feasibility and efficacy outcomes of neoadjuvant modified FOLFIRINOX and postoperative gemcitabine in patients with borderline resectable pancreatic cancer.
Conditions
- Pancreatic Adenocarcinoma
Interventions
- DRUG
-
Preoperative modified FOLFIRINOX and postoperative gemcitabine
* Preoperative mFOLFIRINOX, every 2 weeks, 8 cycles * Oxaliplatin IV 85 mg/m2 Day (D) 1 * Irinotecan IV 180 mg/m2 D1 * 5-FU continuous IV infusion 2,400 mg/m2 over 46 hours D1-2 * Leucovorin IV 400 mg/m2 D1 * Postoperative gemcitabine, every 4 weeks, 3-6 cycles - Gemcitabine 1,000 mg/ m2 D1, 8, and 15
Sponsors & Collaborators
-
Asan Medical Center
lead OTHER
Principal Investigators
-
Baek-Yeol Ryoo, MD, PhD · Asan Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2019-09-30
- Completion
- 2019-11-30
Countries
- South Korea
Study Locations
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