A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients

Phase 2 Completed 25 enrolled University of Michigan Rogel Cancer Center

NaSingle-groupOpen-labelTreatment

Summary

The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to address local disease, will achieve a significant improvement R0 resection (Radiation oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and enhance disease free and overall survival in this patient population.

Timeline

Start: 2011-06
Primary completion: 2017-08-10
Completion: 2019-08-30

Outcome

Missed primary endpoint

paper Although the alternate hypothesis was not met PMID 31494181 ↗

Publications

Tran NH, Sahai V, Griffith KA, Nathan H, Kaza R, Cuneo KC, Shi J, Kim E, Sonnenday CJ, Cho CS, Lawrence TS, Zalupski MM. Phase 2 Trial of Neoadjuvant FOLFIRINOX and Intensity Modulated Radiation Therapy Concurrent With Fixed-Dose Rate-Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2020 Jan 1;106(1):124-133. doi: 10.1016/j.ijrobp.2019.08.057. Epub 2019 Sep 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	140 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	180 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	400 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	400 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	2400 mg/m2	Intravenous