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ACTIVE NOT RECRUITING
NCT03991962
PHASE2

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

Sponsor: Yale University

View on ClinicalTrials.gov

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

Interventions

DRUG

mFOLFIRINOX

Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks

RADIATION

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