NCT01542294

SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer

Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.

Detailed description

This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	s1	60-90mg/m2/d P.O. day 1-14, repeated every 21 days
DRUG	Oxaliplatin	130mg/m2 d1 repeated every 21 days

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-09-01
• Completion: 2017-04-01
• First posted: 2012-03-02
• Last updated: 2016-06-14

Locations

1 site across 1 country: China