25
Participants
Start Date
June 30, 2011
Primary Completion Date
August 10, 2017
Study Completion Date
August 30, 2019
FOLFIRINOX
"Starting dose levels as following:~Oxaliplatin 85mg/m2 intravenously over 120 minutes on day 1. Irinotecan 180mg/m2 intravenously over 90 minutes on day 1. NOTE: patients homozygous for the UGT1A1 (TA)7 promoter allele will be treated at an initial lower dose 140mg/m2 (please see Section 6.3.a) Leucovorin 400mg/m2 intravenously over 90 minutes on day 1. 5FU 400mg/m2 as bolus intravenous injection following leucovorin on day 1. 5FU 2,400mg/m2 infused intravenously as a continuous infusion over 46 hours following the bolus 5FU, beginning on day 1."
Intensity-modulated radiotherapy (IMRT)
50.0Gy in 2.0Gy per fraction
Surgical Exploration
Patients without metastatic disease will be offered surgical exploration.
University of Michigan Comprehensive Cancer Center, Ann Arbor
University of Michigan Rogel Cancer Center
OTHER