9
Participants
Start Date
July 15, 2019
Primary Completion Date
May 24, 2022
Study Completion Date
November 8, 2023
mFOLFIRINOX
"Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:~* Irinotecan 150 mg/m2 IV day 1~* Oxaliplatin 85 mg/m2 IV day 1~* Leucovorin 400 mg/m2 IV day 1~* 5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)~* Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)~* Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3."
Proton beam radiation
Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center, Washington D.C.
Georgetown University
OTHER