Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: TAS-118 plus Oxaliplatin
* Drug: S-1 plus Cisplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAS-118/Oxaliplatin<br>TAS-118 plus Oxaliplatin | Drug: TAS-118 plus Oxaliplatin<br> <br> |
| Active Comparator: S-1/Cisplatin<br>S-1 plus Cisplatin | Drug: S-1 plus Cisplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | PFS was defined as the time from the date of randomization to the date of disease progression (assessed by each investigator) or death from any cause, whichever came first. | 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. | 
| Time to Treatment Failure | TTF was defined as the time from the date of randomization to the date of the last administration of the study drug. Patients on study treatment were censored at the date of the last administration or the cutoff date, whichever came earlier. | From the date of randomization to the date of the last administration of the study drug. | 
| Overall Response Rate | ORR was defined as the proportion of patients with the best unconfirmed overall response of complete response (CR) or partial response (PR) in patients with measurable lesions | 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. | 
| Disease Control Rate | DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, Gastrointestinal Diseases, Gastrointestinal Neoplasms, First Line Treatment, Antineoplastic Agents