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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02322593
Recruitment Status : Completed
First Posted : December 23, 2014
Results First Posted : December 20, 2021
Last Update Posted : December 20, 2021
Sponsor:
Collaborator:
Yakult Honsha Co., LTD
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: TAS-118 plus Oxaliplatin Drug: S-1 plus Cisplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 711 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2014
Actual Primary Completion Date : February 2019
Actual Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: TAS-118/Oxaliplatin
TAS-118 plus Oxaliplatin
 Drug: TAS-118 plus Oxaliplatin
Active Comparator: S-1/Cisplatin
S-1 plus Cisplatin
 Drug: S-1 plus Cisplatin


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322593


Locations
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Japan
Taiho Pharmaceutical Co., Ltd selected site
Ibaraki, Japan, 305-8576
Taiho Pharmaceutical Co., Ltd selected site
Kumamoto, Japan, 860-8556
Taiho Pharmaceutical Co., Ltd selected site
Tokyo, Japan, 104-0045
Korea, Republic of
Taiho Pharmaceutical Co., Ltd selected site
Seoul, Korea, Republic of, 110-744
Taiho Pharmaceutical Co., Ltd selected site
Seoul, Korea, Republic of, 120-752
Taiho Pharmaceutical Co., Ltd selected site
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Yakult Honsha Co., LTD
  Study Documents (Full-Text)

Documents provided by Taiho Pharmaceutical Co., Ltd.:
Study Protocol  [PDF] November 7, 2019
Statistical Analysis Plan  [PDF] February 4, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02322593    
Other Study ID Numbers: 10056040
First Posted: December 23, 2014    Key Record Dates
Results First Posted: December 20, 2021
Last Update Posted: December 20, 2021
Last Verified: November 2021
Keywords provided by Taiho Pharmaceutical Co., Ltd.:
Gastric Cancer
Gastrointestinal Diseases
Gastrointestinal Neoplasms
First Line Treatment
Antineoplastic Agents
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents