NCT03443492

SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer

A Phase II Randomized Study of SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A randomized phase II study to compare the efficacy and safety of SLOG or mFOLFIRINOX as a first-line treatment for patients with locally advanced and metastatic pancreatic cancer.

Detailed description

A total 130 patients (65 patients per arm) with locally advanced or metastatic pancreatic cancer will be enrolled in multiple hospitals of Taiwan. The primary endpoint is progression-free survival. The secondary endpoints are objective response rate, overall survival and safety profiles.

Conditions

• Locally Advanced or Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	S-1	Intervention is administered to patients in this Arm.
DRUG	Leucovorin(oral )	Intervention is administered to patients in this Arm.
DRUG	Gemcitabine	Intervention is administered to patients in this Arm.
DRUG	Oxaliplatin	Intervention is administered to patients in this Arm.
DRUG	Irinotecan	Intervention is administered to patients in this Arm.
DRUG	5-FU	Intervention is administered to patients in this Arm.
DRUG	Leucovorin(IV)	Intervention is administered to patients in this Arm.

Timeline

• Start date: 2018-03-26
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2018-02-23
• Last updated: 2025-12-30

Locations

1 site across 1 country: Taiwan