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Clinical Trial Summary

A Phase II Randomized Study.Primary objective:to investigate the 6-month progression-free survival (PFS) rate i patients receiving SLOG or mFLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer.


Clinical Trial Description

A total of 130 patients (65patients in each arm) will be calculated, based on the assumption of a 6-month PFS rate of 45% with mFOLFIRINOX vs 60% wuth SLOG, to achieve 75% power, with a drop-out rate of 10%. Two-sided test was performed with type I error=0.10. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03443492
Study type Interventional
Source National Health Research Institutes, Taiwan
Contact
Status Enrolling by invitation
Phase Phase 2
Start date March 26, 2018
Completion date December 31, 2020

See also
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Completed NCT03766295 - Masitinib Plus Gemcitabine in Pancreatic Cancer Phase 3
Completed NCT00651742 - Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer Phase 2
Completed NCT01181245 - A Phase 1 Study of Safety and Bioactivity With FG-3019 in Combination With Gemcitabine and Erlotinib for Subjects With Locally Advanced or Metastatic Pancreatic Cancer Phase 1