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Completed

NCT Number: NCT02322593

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taiho Pharmaceutical Co., Ltd selected site, Ibaraki, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TAS-118 plus Oxaliplatin

Drug

S-1 plus cisplatin

Drug

Primary outcomes

  1. Overall Survival

    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.

    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 outcomes

  1. Progression-free Survival

    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.

    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.

  2. Time to Treatment Failure

    Time frame: 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.

  3. Overall Response Rate

    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.

    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

  4. Disease Control Rate

    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.

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

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Yakult Honsha Co., LTD

Registry information

Official study 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

Acronym: SOLAR

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Dec 23, 2014
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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