Pancreatic Cancer Clinical Trial
Official title:
Phase II Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer
The primary objective of this study was to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints included: determine objective response rate according to RECIST; determine overall survival; evaluate toxicity; determine rate of resection in locally advanced unresectable stratum; correlate time to progression, objective response, and overall survival with early changes in glucose metabolism using [18F]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning.
A phase II open label single arm multi-institutional study at Yale's Smilow Cancer Hospital
(New Haven, CT, USA), the Smilow Cancer Hospital Care Centers (regional community-based
clinics), the VA Connecticut Healthcare System West Haven Campus (West Haven, CT, USA) and
Bridgeport Hospital (Bridgeport, CT, USA). The primary objective of this study was to
determine the PFS in patients with MPC and LAPC treated with a dose attenuated modification
of FOLFIRINOX.
NOTE: Upon results reporting (2016), the registration record was reorganized to display MPC
and LAPC groups in individual arms. The most meaningful comparison is between MPC/LAPC and
historical controls. That is how results are reported in the published paper, see citations.
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