Phase 3
N=711
Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02322593 ↗Enrolled (actual)
711
Serious AEs
44.9%
Results posted
Dec 2021
Primary outcome: Primary: Overall Survival — 16.0; 15.1 Months — p=0.039
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TAS-118 plus Oxaliplatin (Drug); S-1 plus Cisplatin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
16.0; 15.1 | 0.039 sig |
| SECONDARY Progression-free Survival |
7.1; 6.4 | 0.0045 sig |
| SECONDARY Time to Treatment Failure |
6.1; 5.3 | 0.011 sig |
| SECONDARY Overall Response Rate |
155; 106 | <0.001 sig |
| SECONDARY Disease Control Rate |
197; 187 | 0.092 |
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.
Data sourced from ClinicalTrials.gov (NCT02322593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.