A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly) versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
338
S-1 : 40 mg/m2, twice daily, Day 1-14
60 mg/m2/day Day 1
130 mg/m2/day Day 1
Seoul National University Bundang Hospital
Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea
National Cancer Center
Ilsan, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun-eup, Hwasun-gun, Jeollanam-do, South Korea
Progression-free survival
The primary endpoint of this study is progression-free survival. This is defined as the time from randomization to disease progression or death due to any cause.
Time frame: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Overall survival
Overall survival is defined as the time from randomization to death due to any cause.
Time frame: From date of randomization to death from any cause, assessed up to 3 years
Response rate
Response assessment will be performed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 every 2 cycles (6 weeks) of treatment.
Time frame: Every 6 weeks
Quality of life
Quality of life of patient will be evaluated using EUROQOL(EQ-5D). Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.
Time frame: Every 6 weeks
Number of Adverse Events
Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.
Time frame: Every 3 weeks
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Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Dongnam Institute of Radiological and Medical Sciences
Busan, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Gangneung Asan Hospital
Gangneung-si, South Korea
Seoul St. Mary's hospital of the Catholic University of Korea
Seoul, South Korea
Asan Medical Center
Seoul, South Korea