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RECRUITING
NCT04452461
PHASE2

Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery

Sponsor: Hamilton Health Sciences Corporation

View on ClinicalTrials.gov

Summary

This is a single-arm, single-center feasibility trial of patients with borderline resectable pancreatic adenocarcinoma receiving chemotherapy with mFOLFIRINOX or gemcitabine / nab-paclitaxel followed by pancreatectomy.

Official title: MFOLFIRINOX or Gemcitabine / Nab-paclitaxel Followed by Pancreatectomy for Patients with Borderline Resectable Pancreatic Adenocarcinoma. a Pilot Feasibility Study.

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-03-01

Completion Date

2026-05-01

Last Updated

2024-10-10

Healthy Volunteers

No

Interventions

DRUG

mFOLFIRINOX

mFOLFIRINOX, including: Oxaliplatin 85 mg/m2 IV over 2 hours, Leucovorin 400mg/m2 IV over 2 hours, Irinotecan at 150 mg/m2 IV over 90 min, 5-Fluoruracil continuous infusion of 2400 mg/m2 IV over 46h.

DRUG

Gemcitabine / Nab-paclitaxel

Both drugs are administered once weekly for three weeks (days 1, 8, 15) followed by a week of rest (28-day cycle) for 3 cycles prior to imaging. Gemcitabine: 1000 mg/m2 intravenous infusion over 30 to 40 minutes. Nab-paclitaxel: 125 mg/m2 intravenous infusion over 30 to 40 minutes.

Locations (1)

Juravinski Hospital

Hamilton, Ontario, Canada