drugset / Trial / NCT01516944

Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

NCT01516944

Phase 2/3 Completed 749 enrolled Hebei Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

Stage I:Neoadjuvant therapy * Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin Stage II: Perioperative therapy * Perioperative Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin * A regimen of Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer.

Timeline

Start
2012-02
Primary completion
2018-04
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 2000 mg/m2
Subject S-1 Small molecule 80 mg/m2
Background Oxaliplatin Small molecule 130 mg/m2

Indications