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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TAS-118 plus Oxaliplatin
S-1 plus Cisplatin
Sponsored by
Taiho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Gastrointestinal Diseases, Gastrointestinal Neoplasms, First Line Treatment, Antineoplastic Agents

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taiho Pharmaceutical Co., Ltd selected site
  • Taiho Pharmaceutical Co., Ltd selected site
  • Taiho Pharmaceutical Co., Ltd selected site
  • Taiho Pharmaceutical Co., Ltd selected site
  • Taiho Pharmaceutical Co., Ltd selected site
  • Taiho Pharmaceutical Co., Ltd selected site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAS-118/Oxaliplatin

S-1/Cisplatin

Arm Description

TAS-118 plus Oxaliplatin

S-1 plus Cisplatin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
Disease Control Rate
DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.

Full Information

First Posted
December 12, 2014
Last Updated
November 10, 2021
Sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborators
Yakult Honsha Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT02322593
Brief Title
Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborators
Yakult Honsha Co., LTD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, Gastrointestinal Diseases, Gastrointestinal Neoplasms, First Line Treatment, Antineoplastic Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
711 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAS-118/Oxaliplatin
Arm Type
Experimental
Arm Description
TAS-118 plus Oxaliplatin
Arm Title
S-1/Cisplatin
Arm Type
Active Comparator
Arm Description
S-1 plus Cisplatin
Intervention Type
Drug
Intervention Name(s)
TAS-118 plus Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
S-1 plus Cisplatin
Primary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
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 Measure Information:
Title
Progression-free Survival
Description
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.
Time Frame
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.
Title
Time to Treatment Failure
Description
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.
Time Frame
From the date of randomization to the date of the last administration of the study drug.
Title
Overall Response Rate
Description
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
Time Frame
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.
Title
Disease Control Rate
Description
DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Taiho Pharmaceutical Co., Ltd selected site
City
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Taiho Pharmaceutical Co., Ltd selected site
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Taiho Pharmaceutical Co., Ltd selected site
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Taiho Pharmaceutical Co., Ltd selected site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Taiho Pharmaceutical Co., Ltd selected site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Taiho Pharmaceutical Co., Ltd selected site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32682457
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.
Results Reference
derived

Learn more about this trial

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

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