Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.
3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w)
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing, China
RECRUITINGPFS
Progression-free survival
Time frame: 6 months
ORR
Objective response rate
Time frame: 6 months
OS
Overall survival
Time frame: 1 year
The number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety
Time frame: 1 year
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