Trial · NCT02322593

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

NCT02322593, Phase 3, Completed, Taiho Pharmaceutical Co., Ltd.; results first posted 2021-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer. Trials, record NCT02322593. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02322593

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
NCT number: NCT02322593
Status: Completed
Phases: Phase 3
Enrollment: 711 participants, actual
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Conditions: Gastric Cancer
Interventions: TAS-118 plus Oxaliplatin, S-1 plus Cisplatin
First posted: 2014-12-23
Last updated: 2021-12-20
Results first posted: 2021-12-20

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	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	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.	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.
Secondary	Time to Treatment Failure	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.
Secondary	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.	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
Secondary	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.	DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	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.	Full Analysis Set (FAS)：Patients in AT population who have advanced gastric cancer at randomization.	Months	MEDIAN
SECONDARY	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.	FAS	Months	MEDIAN
SECONDARY	Time to Treatment Failure	From the date of randomization to the date of the last administration of the study drug.		Months	MEDIAN
SECONDARY	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.	Tumor Response (TR) Evaluable Population： Patients in FAS population presenting measurable lesions (at least one target lesion), evaluated for tumor responses at least once during treatment with the study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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.	TR Evaluable Population：	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival	TAS-118/Oxaliplatin	16.0	95% Confidence Interval 13.8 to 18.3	Months
Overall Survival	S-1/Cisplatin	15.1	95% Confidence Interval 13.6 to 16.4	Months
Progression-free Survival	TAS-118/Oxaliplatin	7.1	95% Confidence Interval 6.8 to 8.3	Months
Progression-free Survival	S-1/Cisplatin	6.4	95% Confidence Interval 5.6 to 6.9	Months
Time to Treatment Failure	TAS-118/Oxaliplatin	6.1	95% Confidence Interval 5.6 to 6.7	Months
Time to Treatment Failure	S-1/Cisplatin	5.3	95% Confidence Interval 4.7 to 6.2	Months
Overall Response Rate	TAS-118/Oxaliplatin	155		Participants
Overall Response Rate	S-1/Cisplatin	106		Participants
Disease Control Rate	TAS-118/Oxaliplatin	197		Participants
Disease Control Rate	S-1/Cisplatin	187		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TAS-118/Oxaliplatin	356
Overall Study	STARTED	S-1/Cisplatin	355
Overall Study	COMPLETED	TAS-118/Oxaliplatin	356
Overall Study	COMPLETED	S-1/Cisplatin	355
Overall Study	NOT COMPLETED	TAS-118/Oxaliplatin	0
Overall Study	NOT COMPLETED	S-1/Cisplatin	0

Source ClinicalTrials.gov

Adverse events394

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	TAS-118/Oxaliplatin	94	352
other	Anaemia	Blood and lymphatic system disorders	S-1/Cisplatin	96	348
other	Leukopenia	Blood and lymphatic system disorders	TAS-118/Oxaliplatin	14	352
other	Leukopenia	Blood and lymphatic system disorders	S-1/Cisplatin	19	348
other	Neutropenia	Blood and lymphatic system disorders	TAS-118/Oxaliplatin	50	352
other	Neutropenia	Blood and lymphatic system disorders	S-1/Cisplatin	53	348
other	Lacrimation increased	Eye disorders	TAS-118/Oxaliplatin	41	352
other	Lacrimation increased	Eye disorders	S-1/Cisplatin	37	348
other	Abdominal pain	Gastrointestinal disorders	TAS-118/Oxaliplatin	46	352
other	Abdominal pain	Gastrointestinal disorders	S-1/Cisplatin	30	348

1 to 10 of 394Source ClinicalTrials.gov

See all 394 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TAS-118/Oxaliplatin	22	352
Total, all-cause mortality	S-1/Cisplatin	8	348
Total, other adverse events	TAS-118/Oxaliplatin	344	352
Total, other adverse events	S-1/Cisplatin	328	348
Total, serious adverse events	TAS-118/Oxaliplatin	155	352
Total, serious adverse events	S-1/Cisplatin	159	348

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32682457	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
TAS-118/Oxaliplatin vs S-1/Cisplatin: deaths from any cause	Trial comparisons
TAS-118/Oxaliplatin vs S-1/Cisplatin: Overall Response Rate	Trial comparisons
TAS-118/Oxaliplatin vs S-1/Cisplatin: Disease Control Rate	Trial comparisons
TAS-118/Oxaliplatin vs S-1/Cisplatin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02322593

GET https://conductscience.org/api/trials/v1/NCT02322593/events?page=2

API reference For AI assistants