NCT00411229

Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer

A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin vs Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4NO), and IIIb (T3N2) Gastric Adenocarcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,035 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary: * To demonstrate that capecitabine/oxaliplatin as adjuvant chemotherapy is superior to observation alone in terms of 3 year disease-free survival (DFS) rate in chemotherapy-naïve patients who underwent potentially curative resection for gastric cancer. Secondary: * To compare the overall survival of surgery and capecitabine/ oxaliplatin as adjuvant therapy versus surgery alone. To evaluate the safety profile of capecitabine/oxaliplatin adjuvant therapy.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	Capecitabine	1,000 mg/m² twice daily. Film coated tablets of 500 mg, 150mg.
DRUG	Oxaliplatin	IV infusion, 130mg/m²

Timeline

• Start date: 2006-06-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2006-12-13
• Last updated: 2013-02-20

Locations

3 sites across 3 countries: China, South Korea, Taiwan