drugset / Trial / NCT02241551

Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer

NCT02241551 ↗

Phase 2 Terminated 2 enrolled Nathan Bahary, MD
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, randomized phase II trial. Patients diagnosed with borderline resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms, either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged with CT scans and if they remain borderline resectable or have improvement of their disease They will then proceed to SBRT followed by surgical resection.

Timeline

Start
2014-12
Primary completion
2017-03-03
Completion
2017-03-03

Outcome

Outcome not reported

Stopped: “Study was terminated with the IRB ended early as logistical concerns of the SBRT”

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule — —
Subject Irinotecan Small molecule — —
Subject Nab-paclitaxel Small molecule — —
Subject Oxaliplatin Small molecule — —
Subject fluorouracil Small molecule — —