Spots Global Cancer Trial Database for Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer
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Trial Identification
Brief Title: Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer
Official Title: A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer
Study ID: NCT00463840
Conditions
Study Description
Brief Summary: The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Bellevue Hospital, New York, New York, United States
NYU Cancer Institute, New York, New York, United States
Contact Details
Name: Theresa Ryan, MD
Affiliation: NYU Langone Health
Role: PRINCIPAL_INVESTIGATOR
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