NCT00498225

Phase III of Gemcitabine Vs TS-1 Vs Gemcitabine Plus TS-1 in Pancreatic Cancer

Randomized Phase III Study of Gemcitabine Versus TS-1 Versus Gemcitabine Plus TS-1 in Unresectable Advanced Pancreatic Cancer (With Local Progression or Metastasis)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 834 (actual)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using survival time.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine plus TS-1	Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.
DRUG	TS-1	TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.
DRUG	Gemcitabine	Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-07-01
• Completion: 2012-06-01
• First posted: 2007-07-09
• Last updated: 2012-11-02

Locations

12 sites across 2 countries: Japan, Taiwan