Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer
This is a single arm trial. All Patients will receive up to 6 cycles of triple chemotherapy
with docetaxel, cisplatin and S-1. Given the severe toxicity of DCF regimen, here the total
dose of docetaxel and cisplatin is both reduced to 60mg/m2. For patients with CR/PR/SD
disease after 6 cycles of chemotherapy, maintenance therapy with S-1 are recommended.
Antitumor activity will be evaluated every two cycles according to RECIST1.1.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival time (OS)
To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.
14 months
No
Aiping Zhou, M.D
Principal Investigator
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
China: State Food and Drug Adminstration
CH-GI-31
NCT01747707
September 2012
May 2014
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