NCT02241551

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Nathan Bahary, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Borderline Resectable Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine/nab-paclitaxel	three cycles of treatment in the gemcitabine/nab-paclitaxel
DRUG	mFOLFIRINOX	6 cycles in the mFOLFIRINOX

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-03-03
• Completion: 2017-03-03
• First posted: 2014-09-16
• Last updated: 2018-07-26
• Results posted: 2018-06-15

Locations

1 site across 1 country: United States