A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer
Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved
survival with a portion of patients proceeding to resection. This trial will incorporate a
similar trial structure using newer agents in patients who present with locally advanced
unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater
activity in comparison to cisplatin and favorable therapeutic index in combination with
radiation compared to gemcitabine.
In summary, the primary outcome measure of the phase I portion of the trial is to determine
the maximum tolerated dose of this combination. Following the determination of this dose,
the phase II portion of the trial will characterize the toxicity of this regimen as well as
evaluate for long-term efficacy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Resectability After Chemoradiation
This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).
Theresa Ryan, MD
New York University School of Medicine
United States: Food and Drug Administration
|NYU Cancer Institute||New York, New York 10016|
|Bellevue Hospital||New York, New York 10016|