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Phase I Pilot Study Using Neoadjuvant FOLFIRINOX and Stereotactic Body Radiotherapy (SBRT) Followed by Definitive Surgery for Patients with Borderline Resectable Pancreatic Adenocarcinoma

Summary

The primary objective of this phase I trial is to determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy. The investigators secondary objectives are to: (1) to assess the disease-free-survival, overall survival, time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT, (2) to investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer, (3) to determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy, and (4) to assess quality of life through and after treatment using the FACT-Hep questionnaire

General Information

NCT#: NCT01992705
Study ID: HP-00055716
Trial Phase: Phase I

Trial Sponsor: University of Maryland
Therapies Used in This Trial: Fluorouracil, Oxaliplatin, Stereotactic body radiotherapy (SBRT), Irinotecan, Leucovorin, FOLFIRINOX

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