Study ID: S1505
This study is comparing modified FOLFIRINOX combination drug therapy to gemcitabine/nab-paclitaxel alone before pancreatic cancer surgery.
Modified FOLFIRINOX potentially reduces side effects of four-drug combination FOLFIRINOX alone. The purpose of this study is to determine whether modified FOLFIRONOX—given to patients before they have had removal or partial removal of the pancreas due to pancreatic adenocarcinoma—is more effective (improves survival) than giving patients gemcitabine/nab-paclitaxel alone before surgery.
To be considered and eligible for this study, you will need to have had a contrast-enhanced CT scan or MRI within the past 28 days before registration for this trial. Patients must also be willing to undergo therapies at designated points in time and attend follow-up appointments and testing as required.
Randomized phase II study of perioperative mFOLFIRINOX vs. gemcitabine/nab-paclitaxel as therapy for resectable pancreatic adenocarcinoma
Patients must have histologically or cytologically proven pancreatic adenocarcinoma Histologies other than adenocarcinoma, or any mixed histologies, will not be eligible No celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery) involvement. No involvement, or < 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence.
Intervention/treatment: mFOLFIRINOX/Surgery vs. Gemcitabine, nab-Paclitaxel and surgery.
- Must be 18 to 75 years old
- Must have histologically or cytologically (diseased tissue examined under microscope) proven pancreatic adenocarcinoma
- Must have surgically operable primary tumor based on contrast-enhanced CT or MRI
Additional criteria may apply.