Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
NCT ID: NCT02322593
Last Updated: 2021-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
711 participants
INTERVENTIONAL
2014-12-31
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAS-118/Oxaliplatin
TAS-118 plus Oxaliplatin
TAS-118 plus Oxaliplatin
S-1/Cisplatin
S-1 plus Cisplatin
S-1 plus Cisplatin
Interventions
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TAS-118 plus Oxaliplatin
S-1 plus Cisplatin
Eligibility Criteria
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Inclusion Criteria
* No prior treatment for gastric cancer.
* Negative or unknown for HER2 testing.
* ECOG performance status of 0 or 1.
Exclusion Criteria
* Current peripheral sensory neuropathy or paresthesia.
* Pregnant or lactating female.
20 Years
ALL
No
Sponsors
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Yakult Honsha Co., LTD
INDUSTRY
Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Taiho Pharmaceutical Co., Ltd selected site
Ibaraki, , Japan
Taiho Pharmaceutical Co., Ltd selected site
Kumamoto, , Japan
Taiho Pharmaceutical Co., Ltd selected site
Tokyo, , Japan
Taiho Pharmaceutical Co., Ltd selected site
Seoul, , South Korea
Taiho Pharmaceutical Co., Ltd selected site
Seoul, , South Korea
Taiho Pharmaceutical Co., Ltd selected site
Seoul, , South Korea
Countries
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References
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Kang YK, Chin K, Chung HC, Kadowaki S, Oh SC, Nakayama N, Lee KW, Hara H, Chung IJ, Tsuda M, Park SH, Hosaka H, Hironaka S, Miyata Y, Ryu MH, Baba H, Hyodo I, Bang YJ, Boku N. S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 Aug;21(8):1045-1056. doi: 10.1016/S1470-2045(20)30315-6. Epub 2020 Jul 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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10056040
Identifier Type: -
Identifier Source: org_study_id