A Phase II Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients With Borderline Resectable Pancreatic Cancer
Gemcitabine has been the cornerstone of systemic therapy for pancreas cancer over this past
decade. Recently, a combination of 5-fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX)
was reported to have significant efficacy in advanced pancreatic cancer. Preclinical data
suggests synergy between irinotecan and 5FU as well as between oxaliplatin and 5FU. Results
of a phase II trial in advanced disease were reported in 2005 demonstrating a 26% confirmed
response rate and median overall survival of 10.2 months. A follow-up phase III trial
comparing FOLFIRINOX with gemcitabine for patients <75 years of age with advanced pancreatic
cancer was presented at ASCO 2010 revealing improvement in PFS (6.4 vs 3.3 months, p=<.0001)
and improved disease control rate (CR+PR+SD) (70.2% vs 50.9%, p=.0003). The most notable
result was an impressive improvement in median overall survival with FOLFIRINOX compared to
gemcitabine (11.1vs 6.8 months, p-value = <.0001, HR=.57). The main toxicity was grade 3/4
neutropenia (45.7% vs 18.7%, p=.0001) and increased risk of febrile neutropenia (5.4% vs
0.6%, p=.009)31.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Resection
To determine the frequency of achieving an R0 resection using a neoadjuvant regimen of FOLFIRINOX followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine in patients with borderline resectable pancreatic cancer.
6 months
No
Mark Zalupski, MD
Principal Investigator
University of Michigan Cancer Center
United States: Food and Drug Administration
UMCC 2011.007
NCT01661088
June 2011
June 2017
Name | Location |
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University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |