NCT03600623

Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer

Neoadjuvant Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy (SBRT) for Patients With Locally Advanced Pancreatic Cancer

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will implement a new treatment regimen for patients with advanced and inoperable pancreatic cancer using chemotherapy combinations of Folfirinox or gemcitabine-nab paclitaxel (abraxane) followed by a short course of high dose radiation called Stereotactic Body Radiation Therapy (SBRT). While the chemotherapy is standard of care, the strategy of adding SBRT has not been investigated. An increase in the percentage of patients who can proceed to have surgery to remove their disease is anticipated with this approach.

Detailed description

This pilot study will evaluate safety and tolerability of neoadjuvant chemotherapy followed by SBRT. Patients with locally advanced pancreatic cancer (LAPC) and borderline pancreatic inoperable cancer will be assigned to one of two treatment arms based upon performance status and physician's discretion. The two treatment arms are: Folfirinox or gemcitabine-nab paclitaxel (abraxane). There are no study drugs as all treatments are based on standard clinical pathways. After two cycles of treatment patients will be restaged with CT scans or imaging. If the tumor remains resectable, borderline, or unresectable without progression of disease, then the patient will proceed to SBRT. Follow-up visits will continue every three months for up to one year or until progression of disease.

Conditions

• Locally Advanced Pancreatic Cancer
• Borderline Pancreatic Inoperable Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Folfirinox	SBRT will follow Folfirinox at the completion of Cycle 2 (if eligible).
DRUG	Gemcitabine nab-Paclitaxel	SBRT will follow Gemcitabine nab-Paclitaxel at the completion of Cycle 2 (if eligible).

Timeline

• Start date: 2017-09-25
• Primary completion: 2020-07-30
• Completion: 2020-07-31
• First posted: 2018-07-26
• Last updated: 2020-08-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study