The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.
The primary endpoint is Overall survival time (OS).Secondary endpoints are overall response rate (ORR), time to treatment failure (TTF),progression free survival (PFS)and the adverse reactions(AE) of the two groups . Study design: This is a prospective randomized control study. Sample size: Sample size considerations were based on the survival end point. The improvement in median survival from 10 months in the S-1+cisplatin arm to 13 months in the S-1+oxaliplatin arm was considered clinically relevant in this patient population. A total of 576 patients were required for a two-tailed log-rank test at the 5% significance and at least 80% power. The planned enrolled time was 48 months and 1 year of follow up, and a drop-out rate of 5%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
576
S-1:40\~60mg bid,d1\~14 q3W
oxaliplatin:130mg/m2,iv drip for 2h,d1,q3W
cisplatin:60mg/m2,iv drip ,d1,q3W
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Overall Survival
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost
Time frame: 1-1.5 year
Objective response rate
The primary endpoint is objective response rate,which equals CR+PR.
Time frame: 1 year
time to treatment failure (TTF)
The duration is from the randomized time to treatment termination due to any reason. The reasons may include disease progression, treatment toxicity, patient selection or death.
Time frame: 6 months
progression-free survival (PFS)
The duration is from the randomized time to disease progression or death due to any reason.
Time frame: 6 months
Adverse events (AE)
Time frame: 1-1.5 years
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