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

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: S-1 plus Cisplatin; Drug: TAS-118 plus Oxaliplatin

• Registration Number: NCT02322593
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-23
• Primary Completion: 2019-02
• Study Completion: 2020-05
• Results First Submitted: 2021-08-24
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-10
• Last Update Submitted: 2021-11-10
• Results First Posted: 2021-12-20
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 711

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-1/Cisplatin	S-1 plus Cisplatin	S-1 plus Cisplatin
TAS-118/Oxaliplatin	TAS-118 plus Oxaliplatin	TAS-118 plus Oxaliplatin

Primary Outcome Measures

Name	Time	Method
Overall Survival	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.	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.

Secondary Outcome Measures

Name	Time	Method
Time to Treatment Failure	From the date of randomization to the date of the last administration of the study drug.	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.
Progression-free Survival	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.	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.
Disease Control Rate	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.	DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.
Overall Response Rate	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.	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

Trial Locations

Locations (1)

Taiho Pharmaceutical Co., Ltd selected site; 🇰🇷 Seoul, Korea, Republic of