Who is sponsoring NCT03991962?

NCT03991962 is sponsored by Yale University.

What condition does NCT03991962 study?

NCT03991962 studies Pancreatic Cancer.

What drugs are being tested in NCT03991962?

Interventions: mFOLFIRINOX, Stereotactic body radiotherapy (SBRT).

What is the status of NCT03991962?

NCT03991962 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-12-22 · How we verify

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

NCT03991962 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Yale University
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	28
Start date	2019-09-24
Completion	2027-02

Conditions

Pancreatic Cancer

Interventions

mFOLFIRINOX
Stereotactic body radiotherapy (SBRT)

Primary outcomes

Progression Free Survival — 9 months
Progression-free survival (PFS) at will be judged by CT scan and Response evaluation criteria in solid tumors (RECIST).

Countries

United States