NCT01935778

Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer at Stage IIIb and IV(KCSG ST15-08): TRIUMPH

A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) Who Received Radical Resection(KCSG ST15-08)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

multicenter, open label, randomaized, phase III The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are currently accepted as a standard therapy among the AGC patients who were performed gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as one of the best treatments for IIB and IV(M0) stage AGC patients who were performed gastrectomy.

Conditions

• Gastric Cancer, Adjuvant Chemotherapy, XO

Interventions

Type	Name	Description
DRUG	Docetaxel and capecitabine and oxaliplatin	Docetaxel 60 mg/m² IV Day 1 Capecitabine 800 mg/m² bid (Day 1-Day 14) Oxaliplatin 100 mg/m² IV Day 1
DRUG	capecitabine and oxaliplatin	Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1

Timeline

• Start date: 2013-10-02
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2013-09-05
• Last updated: 2024-02-28

Locations

1 site across 1 country: South Korea