NCT02322593

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
711

participants targeted

Target at P75+ for phase_3 gastric-cancer

Timeline
Completed

Started Dec 2014

Typical duration for phase_3 gastric-cancer

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 20, 2021

Completed
Last Updated

December 20, 2021

Status Verified

November 1, 2021

Enrollment Period

4.2 years

First QC Date

December 12, 2014

Results QC Date

August 24, 2021

Last Update Submit

November 10, 2021

Conditions

Gastric Cancer

Keywords

Gastric CancerGastrointestinal DiseasesGastrointestinal NeoplasmsFirst Line TreatmentAntineoplastic Agents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

  • Time to Treatment Failure

    From the date of randomization to the date of the last administration of the study drug.

  • 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.

  • 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.

Study Arms (2)

TAS-118/Oxaliplatin

EXPERIMENTAL

TAS-118 plus Oxaliplatin

Drug: TAS-118 plus Oxaliplatin

S-1/Cisplatin

ACTIVE COMPARATOR

S-1 plus Cisplatin

Drug: S-1 plus Cisplatin

Interventions

TAS-118 plus OxaliplatinDRUG
TAS-118/Oxaliplatin
S-1 plus CisplatinDRUG
S-1/Cisplatin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unmanageable diarrhea.
  • Current peripheral sensory neuropathy or paresthesia.
  • Pregnant or lactating female.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Taiho Pharmaceutical Co., Ltd selected site

Ibaraki, 305-8576, Japan

Location

Taiho Pharmaceutical Co., Ltd selected site

Kumamoto, 860-8556, Japan

Location

Taiho Pharmaceutical Co., Ltd selected site

Tokyo, 104-0045, Japan

Location

Taiho Pharmaceutical Co., Ltd selected site

Seoul, 110-744, South Korea

Location

Taiho Pharmaceutical Co., Ltd selected site

Seoul, 120-752, South Korea

Location

Taiho Pharmaceutical Co., Ltd selected site

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32682457DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsGastrointestinal DiseasesGastrointestinal Neoplasms

Interventions

OxaliplatinS-1 plus cisplatin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Results Point of Contact

Title
Taiho Pharmaceutical Co., Ltd.
Organization
Clinical Trial Registration Contact
toiawase@taiho.co.jp

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 23, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2019

Study Completion

May 1, 2020

Last Updated

December 20, 2021

Results First Posted

December 20, 2021

Record last verified: 2021-11

Locations

KR(3)JP(3)