The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with the PFS being around 6 months and overall survival time being 13 months in Japanese and Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin and S-1 (DCS) as first line chemotherapy for patients with 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGoverall survival time (OS)
To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.
Time frame: 14 months
Progression free survival (PFS)
To determine the PFS of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer
Time frame: 6 months
safety profile
To determine the tolerability of DCS in patients with chemo-naive, gastric or gastroesophageal junction cancer.
Time frame: 4 months
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