NCT01583361

SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer

Phase III, Randomized, Multicenter, Controlled Evaluation of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 772 (estimated)
• Sponsor: Lin Chen · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, controlled trial to prove efficacy of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy. The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Oxaliplatin+S-1	S-1: 40\~60mg bid，po, d1\~14 （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1
DRUG	Adjuvant Oxaliplatin/S-1（SOX）	S-1：40\~60mg bid，d1\~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months)

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-09-01
• Completion: 2017-01-01
• First posted: 2012-04-24
• Last updated: 2012-04-24

Locations

1 site across 1 country: China