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Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma
Sponsor: Yale University
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2019-09-24
Completion Date
2027-02
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
mFOLFIRINOX
Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks
Stereotactic body radiotherapy (SBRT)
Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved lymph nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
Locations (1)
Yale University School of Medicine
New Haven, Connecticut, United States