S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients
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|ClinicalTrials.gov Identifier: NCT01824459|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: S-1 Drug: Oxaliplatin Drug: Cisplatin||Phase 3|
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 .
This is a prospective randomized control study.
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 (Clinical Trial)|
|Actual Enrollment :||576 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open, Multi-center, Phase III Study of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||December 1, 2018|
Active Comparator: S-1 + cisplatin(SP)
S-1：40~60mg bid，d1~14 q3W cisplatin：60mg/m2，iv drip ，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.
S-1：40~60mg bid，d1~14 q3W
cisplatin：60mg/m2，iv drip ，d1,q3W
S-1：40~60mg bid，d1~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.
S-1：40~60mg bid，d1~14 q3W
oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W
- Overall Survival [ Time Frame: 1-1.5 year ]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
- Objective response rate [ Time Frame: 1 year ]The primary endpoint is objective response rate,which equals CR+PR.
- time to treatment failure (TTF) [ Time Frame: 6 months ]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.
- progression-free survival (PFS) [ Time Frame: 6 months ]The duration is from the randomized time to disease progression or death due to any reason.
- Adverse events (AE) [ Time Frame: 1-1.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824459
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||ruihua xu, Professor||SunYat-sen University Cancer Center|