The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Bellevue Hospital
New York, New York, United States
NYU Cancer Institute
New York, New York, United States
Resectability After Chemoradiation
This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).
Time frame: 7.5 weeks
Median Overall Survival
This is the time at which 50% of patients are alive from the trial entry .
Time frame: up to 10 years since the start of the study
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this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin