Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-01 @ 11:14 PM
Study NCT ID:
NCT03443492
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2018-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SLOG Vs MFOLFIRINOX As the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
Sponsor:
National Health Research Institutes, Taiwan
Organization:
Study Overview
Official Title:
A Phase II Randomized Study of SLOG Vs MFOLFIRINOX As the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pancreas
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: