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Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma

Pancreatic Cancer Clinical Trial

Official title:
Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of modified FOLFIRINOX followed by stereotactic body radiotherapy (SBRT) in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). The primary hypothesis will be to determine if modified FOLFIRINOX followed by SBRT improves progression free survival (PFS) compared to historical controls treated with gemcitabine-based chemotherapy with or without standard fractionated radiation.

Clinical Trial Description

The Primary and Secondary are listed below. Primary Objective: - To evaluate progression free survival after modified FOLFIRINOX and SBRT in borderline resectable and locally advanced pancreatic cancer. Secondary Objective: - To evaluate the radiographic response to FOLFIRINOX and SBRT by comparing IV contrast CT scans before and after therapy. - To determine rates of recurrence (local only, systemic only, and both local and systemic), and overall survival. - To determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03991962
Study type Interventional
Source Yale University
Contact Kimberly Johung, MD, PhD
Phone 203-737-6876
Email kimberly.johung@yale.edu
Status Recruiting
Phase Phase 2
Start date September 19, 2019
Completion date February 2025
View Details
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