drugset / Trial / NCT01583361

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

NCT01583361

Phase 3 Unknown 772 enrolled Lin Chen
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-03
Primary completion
2014-09
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject S-1 Small molecule 40 mg Oral
Subject S-1 Small molecule 50 mg Oral
Subject S-1 Small molecule 60 mg Oral