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

Gastric Cancer Clinical Trial

— SOLAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322593
• Other study ID #: 10056040
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: May 2020

Study information

• Verified date: November 2021
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: May 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• TAS-118 plus Oxaliplatin

• S-1 plus Cisplatin

Locations

Country	Name	City	State
Japan	Taiho Pharmaceutical Co., Ltd selected site	Ibaraki
Japan	Taiho Pharmaceutical Co., Ltd selected site	Kumamoto
Japan	Taiho Pharmaceutical Co., Ltd selected site	Tokyo
Korea, Republic of	Taiho Pharmaceutical Co., Ltd selected site	Seoul
Korea, Republic of	Taiho Pharmaceutical Co., Ltd selected site	Seoul
Korea, Republic of	Taiho Pharmaceutical Co., Ltd selected site	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.	Yakult Honsha Co., LTD

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.