NCT00142350

A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 690 (planned)
• Sponsor: Japan Clinical Oncology Group · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer

Detailed description

From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	continuous infusion of 5-fluorouracil
DRUG	combination of irinotecan and cisplatin
DRUG	oral administration of S-1

Timeline

• Start date: 2000-11-01
• Completion: 2007-01-01
• First posted: 2005-09-02
• Last updated: 2016-09-12

Locations

34 sites across 1 country: Japan