Gastric CancerPhase 3SOLARNCT02322593
Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
A Phase 3 study testing TAS-118 plus Oxaliplatin and S-1 plus Cisplatin in people with Gastric Cancer, run by Taiho Pharmaceutical Co., Ltd. at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- TAS-118 plus Oxaliplatin and S-1 plus Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 711 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Dec 2014to May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unmanageable diarrhea.
- Current peripheral sensory neuropathy or paresthesia.
- Pregnant or lactating female.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Japan3 sites
Taiho Pharmaceutical Co., Ltd selected site
Ibaraki, 305-8576
Taiho Pharmaceutical Co., Ltd selected site
Kumamoto, 860-8556
Taiho Pharmaceutical Co., Ltd selected site
Tokyo, 104-0045
South Korea3 sites
Taiho Pharmaceutical Co., Ltd selected site
Seoul, 110-744
Taiho Pharmaceutical Co., Ltd selected site
Seoul, 120-752
Taiho Pharmaceutical Co., Ltd selected site
Seoul, 138-736
About this study
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
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.
- Conditions
- Gastric Cancer
- Being tested
- TAS-118 plus Oxaliplatin, S-1 plus Cisplatin
- Keywords
- Gastric Cancer, Gastrointestinal Diseases, Gastrointestinal Neoplasms, First Line Treatment, Antineoplastic Agents
- Medical subject headings
- Stomach Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-118 plus OxaliplatinDrug
S-1 plus CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| TAS-118/Oxaliplatin | Experimental | TAS-118 plus Oxaliplatin Receives: Drug: TAS-118 plus Oxaliplatin |
| S-1/Cisplatin | Active comparator | S-1 plus Cisplatin Receives: Drug: S-1 plus Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: From the date of randomization to the date of the last administration of the study drug.
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
Measured: 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
DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yakult Honsha Co., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322593
- Sponsor's protocol ID
- 10056040
- Acronym
- SOLAR
- Status last verified
- Nov 2021
- First submitted
- 12 Dec 2014
- Last updated
- 20 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32682457
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02322593
- Acronym / sponsor ID
- SOLAR / 10056040
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Gastrointestinal Diseases, Gastrointestinal Neoplasms, First Line Treatment, Antineoplastic Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- Dec 2014 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 20 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS-118/Oxaliplatin | Experimental | Drug: TAS-118 plus OxaliplatinTAS-118 plus Oxaliplatin |
| S-1/Cisplatin | Active comparator | Drug: S-1 plus CisplatinS-1 plus Cisplatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- Unmanageable diarrhea.
- Current peripheral sensory neuropathy or paresthesia.
- Pregnant or lactating female.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-118 plus Oxaliplatin | Drug | TAS-118/Oxaliplatin |
| S-1 plus Cisplatin | Drug | S-1/Cisplatin |
Primary outcome
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.
4 secondary outcomes
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.
Time to Treatment Failure
Time frame: From the date of randomization to the date of the last administration of the study drug.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32682457Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAS-118 plus Oxaliplatin and S-1 plus Cisplatin in people with Gastric Cancer, run by Taiho Pharmaceutical Co., Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.