Clinical trial NCT02322593: Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
Official title: An Open-label Randomized Multi-center Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Gastrointestinal Diseases
Gastrointestinal Neoplasms
First Line Treatment
Antineoplastic Agents
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Yakult Honsha Co., LTD
First posted: 2014-12-23
Enrollment: 711
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.


Eligibility criteria: Key Inclusion Criteria:

* Patients who are diagnosed as gastric cancer.
* No prior treatment for gastric cancer.
* Negative or unknown for HER2 testing.
* ECOG performance status of 0 or 1.

Key Exclusion Criteria:

* Unmanageable diarrhea.
* Current peripheral sensory neuropathy or paresthesia.
* Pregnant or lactating female.

Primary outcomes:
measure: Overall Survival
timeFrame: A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months.
Secondary outcomes:
measure: Progression-free Survival
timeFrame: A radiographic imaging examination using CT or MRI was repeated every 6 weeks. Tumor assessments were performed from the date of randomization to the date of disease progression or death from any cause, whichever came first.
measure: Time to Treatment Failure
timeFrame: From the date of randomization to the date of the last administration of the study drug.
measure: Overall Response Rate
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.
measure: Disease Control Rate
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.
Other outcomes:
Locations:
city: Ibaraki
country: Japan
facility: Taiho Pharmaceutical Co., Ltd selected site
city: Kumamoto
country: Japan
facility: Taiho Pharmaceutical Co., Ltd selected site
city: Tokyo
country: Japan
facility: Taiho Pharmaceutical Co., Ltd selected site
city: Seoul
country: Korea, Republic of
facility: Taiho Pharmaceutical Co., Ltd selected site
city: Seoul
country: Korea, Republic of
facility: Taiho Pharmaceutical Co., Ltd selected site
city: Seoul
country: Korea, Republic of
facility: Taiho Pharmaceutical Co., Ltd selected site
Study officials:
References:
citation: 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.