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

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ClinicalTrials.gov Identifier: NCT02322593

Recruitment Status : Completed

First Posted : December 23, 2014

Results First Posted : December 20, 2021

Last Update Posted : December 20, 2021

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Sponsor:

Collaborator:

Yakult Honsha Co., LTD

Information provided by (Responsible Party):

Taiho Pharmaceutical Co., Ltd.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Gastric Cancer
Interventions	Drug: TAS-118 plus Oxaliplatin Drug: S-1 plus Cisplatin
Enrollment	711

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	TAS-118/Oxaliplatin	S-1/Cisplatin
Arm/Group Description	TAS-118 plus Oxaliplatin ...	S-1 plus Cisplatin ...
Arm/Group Description	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
Period Title: Overall Study
Started	356	355
Completed	356	355
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		TAS-118/Oxaliplatin	S-1/Cisplatin	Total
Arm/Group Description		TAS-118 plus Oxaliplatin ...	S-1 plus Cisplatin ...	Total of all reporting groups
Arm/Group Description		TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	Total of all reporting groups
Overall Number of Baseline Participants		347	334	681
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Full Analysis Set (FAS)：Patients in AT population who have advanced gastric cancer at randomization.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	347 participants	334 participants	681 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	201 57.9%	194 58.1%	395 58.0%
	>=65 years	146 42.1%	140 41.9%	286 42.0%
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	347 participants	334 participants	681 participants
		62.0 (21 to 79)	62.0 (26 to 80)	62.0 (21 to 80)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	347 participants	334 participants	681 participants
	Female	96 27.7%	116 34.7%	212 31.1%
	Male	251 72.3%	218 65.3%	469 68.9%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	347 participants	334 participants	681 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	347 100.0%	334 100.0%	681 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	347 participants	334 participants	681 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	347 100.0%	334 100.0%	681 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	347 participants	334 participants	681 participants
Japan		221	212	433
South Korea		126	122	248

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	The primary endpoint was OS, which was defined as the time from the da...
Description	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.
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.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS)：Patients in AT population who have advanced gastric cancer at randomization.


Arm/Group Title	TAS-118/Oxaliplatin	S-1/Cisplatin
Arm/Group Description:	TAS-118 plus Oxaliplatin ...	S-1 plus Cisplatin ...
Arm/Group Description:	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
Overall Number of Participants Analyzed	347	334
Median (95% Confidence Interval) Unit of Measure: Months
	16.0 (13.8 to 18.3)	15.1 (13.6 to 16.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAS-118/Oxaliplatin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.039
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95% 0.69 to 0.99
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.091
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Progression-free Survival
Description	PFS was defined as the time from the date of randomization to the date...
Description	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.
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.

Outcome Measure Data

Analysis Population Description

FAS


Arm/Group Title	TAS-118/Oxaliplatin	S-1/Cisplatin
Arm/Group Description:	TAS-118 plus Oxaliplatin ...	S-1 plus Cisplatin ...
Arm/Group Description:	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
Overall Number of Participants Analyzed	347	334
Median (95% Confidence Interval) Unit of Measure: Months
	7.1 (6.8 to 8.3)	6.4 (5.6 to 6.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAS-118/Oxaliplatin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0045
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95% 0.66 to 0.93
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.086
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Time to Treatment Failure
Description	TTF was defined as the time from the date of randomization to the date...
Description	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.
Time Frame	From the date of randomization to the date of the last administration of the study drug.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	TAS-118/Oxaliplatin	S-1/Cisplatin
Arm/Group Description:	TAS-118 plus Oxaliplatin ...	S-1 plus Cisplatin ...
Arm/Group Description:	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
Overall Number of Participants Analyzed	347	334
Median (95% Confidence Interval) Unit of Measure: Months
	6.1 (5.6 to 6.7)	5.3 (4.7 to 6.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAS-118/Oxaliplatin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.011
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95% 0.70 to 0.96
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.078
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Overall Response Rate
Description	ORR was defined as the proportion of patients with the best unconfirme...
Description	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
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.

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	TAS-118/Oxaliplatin	S-1/Cisplatin
Arm/Group Description:	TAS-118 plus Oxaliplatin ...	S-1 plus Cisplatin ...
Arm/Group Description:	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
Overall Number of Participants Analyzed	211	212
Measure Type: Count of Participants Unit of Measure: Participants
	155 73.5%	106 50.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAS-118/Oxaliplatin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

5.Secondary Outcome


Title	Disease Control Rate
Description	DCR was defined as the proportion of patients with CR, PR, or stable d...
Description	DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.
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.

Outcome Measure Data

Analysis Population Description

TR Evaluable Population：


Arm/Group Title	TAS-118/Oxaliplatin	S-1/Cisplatin
Arm/Group Description:	TAS-118 plus Oxaliplatin ...	S-1 plus Cisplatin ...
Arm/Group Description:	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
Overall Number of Participants Analyzed	211	212
Measure Type: Count of Participants Unit of Measure: Participants
	197 93.4%	187 88.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAS-118/Oxaliplatin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.092
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Adverse Events

Time Frame	From the time a patient signed informed consent until 30 day safety follow-up visit or initiation of new anticancer treatment, whichever was earlier, an average assessed up to 42 months.
Adverse Event Reporting Description	An adverse event (AE) is any untoward medical condition that occurs in a patient while participating in a clinical study and does not necessarily have a causal relationship with the use of the product. Treatment emergent adverse events are AEs that occur from the initiation of any study medication administration, and do not necessarily have a causal relationship to the use of the study medication.

Arm/Group Title	TAS-118/Oxaliplatin	S-1/Cisplatin
Arm/Group Description	TAS-118 plus Oxaliplatin ...	S-1 plus Cisplatin ...
Arm/Group Description	TAS-118 plus Oxaliplatin L-OHP was administered intravenously at dose of 85 mg/m2 on day 1, and TAS-118 were administered 30-60 mg orally twice daily for 7 days (day 1 through day 7), repeated every 2 weeks. Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.	S-1 plus Cisplatin CDDP was administered intravenously at dose of 60 mg/m2 on day 1 (Korea) or day 8 (Japan), and S-1 were administered 40-60 mg orally twice daily for 21 days (day 1 through day 21), repeated every 5 weeks (rest period can be shorten from 14 days to 7 days). Treatment was continued during the study period unless any of Study Treatment Discontinuation Criteria was met.
All-Cause Mortality
	TAS-118/Oxaliplatin	S-1/Cisplatin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	22/352 (6.25%)	8/348 (2.30%)
Serious Adverse Events Serious Adverse Events
	TAS-118/Oxaliplatin	S-1/Cisplatin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	155/352 (44.03%)	159/348 (45.69%)
Blood and lymphatic system disorders
Anaemia ^† 1	2/352 (0.57%)	5/348 (1.44%)
Disseminated intravascular coagulation ^† 1	3/352 (0.85%)	0/348 (0.00%)
Febrile neutropenia ^† 1	4/352 (1.14%)	6/348 (1.72%)
Lymphadenitis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Cardiac disorders
Acute myocardial infarction ^† 1	0/352 (0.00%)	1/348 (0.29%)
Prinzmetal angina ^† 1	0/352 (0.00%)	1/348 (0.29%)
Eye disorders
Rhegmatogenous retinal detachment ^† 1	1/352 (0.28%)	0/348 (0.00%)
Gastrointestinal disorders
Abdominal distension ^† 1	0/352 (0.00%)	3/348 (0.86%)
Abdominal pain ^† 1	10/352 (2.84%)	9/348 (2.59%)
Abdominal pain upper ^† 1	1/352 (0.28%)	0/348 (0.00%)
Ascites ^† 1	5/352 (1.42%)	8/348 (2.30%)
Cheilitis ^† 1	1/352 (0.28%)	0/348 (0.00%)
Colitis ^† 1	1/352 (0.28%)	0/348 (0.00%)
Diarrhoea ^† 1	14/352 (3.98%)	8/348 (2.30%)
Dyspepsia ^† 1	0/352 (0.00%)	1/348 (0.29%)
Dysphagia ^† 1	1/352 (0.28%)	1/348 (0.29%)
Enteritis ^† 1	5/352 (1.42%)	2/348 (0.57%)
Enterocolitis ^† 1	3/352 (0.85%)	0/348 (0.00%)
Gastric haemorrhage ^† 1	3/352 (0.85%)	2/348 (0.57%)
Gastric perforation ^† 1	0/352 (0.00%)	3/348 (0.86%)
Gastric ulcer haemorrhage ^† 1	0/352 (0.00%)	1/348 (0.29%)
Gastrointestinal haemorrhage ^† 1	0/352 (0.00%)	2/348 (0.57%)
Gastrointestinal necrosis ^† 1	1/352 (0.28%)	0/348 (0.00%)
Gastrointestinal perforation ^† 1	0/352 (0.00%)	1/348 (0.29%)
Haematemesis ^† 1	1/352 (0.28%)	0/348 (0.00%)
Haematochezia ^† 1	1/352 (0.28%)	0/348 (0.00%)
Ileus ^† 1	7/352 (1.99%)	5/348 (1.44%)
Ileus paralytic ^† 1	0/352 (0.00%)	1/348 (0.29%)
Inguinal hernia ^† 1	0/352 (0.00%)	1/348 (0.29%)
Large intestine perforation ^† 1	0/352 (0.00%)	1/348 (0.29%)
Nausea ^† 1	11/352 (3.13%)	6/348 (1.72%)
Obstruction gastric ^† 1	3/352 (0.85%)	8/348 (2.30%)
Pancreatitis ^† 1	1/352 (0.28%)	0/348 (0.00%)
Rectal stenosis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Small intestinal obstruction ^† 1	0/352 (0.00%)	3/348 (0.86%)
Stomatitis ^† 1	0/352 (0.00%)	2/348 (0.57%)
Vomiting ^† 1	4/352 (1.14%)	1/348 (0.29%)
Oesophageal discomfort ^† 1	1/352 (0.28%)	0/348 (0.00%)
Haemorrhoidal haemorrhage ^† 1	1/352 (0.28%)	0/348 (0.00%)
Gastric stenosis ^† 1	2/352 (0.57%)	4/348 (1.15%)
Large intestinal obstruction ^† 1	2/352 (0.57%)	0/348 (0.00%)
Rectal obstruction ^† 1	0/352 (0.00%)	1/348 (0.29%)
Large intestinal stenosis ^† 1	2/352 (0.57%)	0/348 (0.00%)
General disorders
Asthenia ^† 1	4/352 (1.14%)	2/348 (0.57%)
Condition aggravated ^† 1	1/352 (0.28%)	0/348 (0.00%)
Death ^† 1	1/352 (0.28%)	1/348 (0.29%)
Fatigue ^† 1	3/352 (0.85%)	4/348 (1.15%)
Malaise ^† 1	2/352 (0.57%)	2/348 (0.57%)
Mucosal inflammation ^† 1	1/352 (0.28%)	1/348 (0.29%)
Mucous membrane disorder ^† 1	1/352 (0.28%)	0/348 (0.00%)
Oedema peripheral ^† 1	0/352 (0.00%)	1/348 (0.29%)
Pain ^† 1	1/352 (0.28%)	0/348 (0.00%)
Pyrexia ^† 1	10/352 (2.84%)	5/348 (1.44%)
Disease progression ^† 1	5/352 (1.42%)	1/348 (0.29%)
Complication associated with device ^† 1	1/352 (0.28%)	0/348 (0.00%)
Hepatobiliary disorders
Bile duct stone ^† 1	0/352 (0.00%)	1/348 (0.29%)
Cholangitis ^† 1	1/352 (0.28%)	1/348 (0.29%)
Cholangitis acute ^† 1	1/352 (0.28%)	0/348 (0.00%)
Cholecystitis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Cholecystitis acute ^† 1	0/352 (0.00%)	1/348 (0.29%)
Hepatic failure ^† 1	1/352 (0.28%)	0/348 (0.00%)
Hepatic function abnormal ^† 1	1/352 (0.28%)	2/348 (0.57%)
Jaundice ^† 1	0/352 (0.00%)	1/348 (0.29%)
Jaundice cholestatic ^† 1	3/352 (0.85%)	1/348 (0.29%)
Bile duct stenosis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Bile duct obstruction ^† 1	0/352 (0.00%)	1/348 (0.29%)
Biliary dilatation ^† 1	1/352 (0.28%)	0/348 (0.00%)
Infections and infestations
Appendicitis ^† 1	2/352 (0.57%)	0/348 (0.00%)
Atypical pneumonia ^† 1	1/352 (0.28%)	0/348 (0.00%)
Dacryocystitis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Diverticulitis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Infection ^† 1	1/352 (0.28%)	0/348 (0.00%)
Influenza ^† 1	1/352 (0.28%)	0/348 (0.00%)
Peritonitis ^† 1	2/352 (0.57%)	0/348 (0.00%)
Pneumonia ^† 1	8/352 (2.27%)	7/348 (2.01%)
Pneumonia herpes viral ^† 1	1/352 (0.28%)	0/348 (0.00%)
Pneumonia pneumococcal ^† 1	0/352 (0.00%)	1/348 (0.29%)
Pulmonary tuberculosis ^† 1	2/352 (0.57%)	0/348 (0.00%)
Sepsis ^† 1	3/352 (0.85%)	2/348 (0.57%)
Upper respiratory tract infection ^† 1	1/352 (0.28%)	0/348 (0.00%)
Urethritis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Urinary tract infection ^† 1	4/352 (1.14%)	1/348 (0.29%)
Cytomegalovirus enterocolitis ^† 1	1/352 (0.28%)	0/348 (0.00%)
Cytomegalovirus enteritis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Enterocolitis infectious ^† 1	0/352 (0.00%)	1/348 (0.29%)
Enteritis infectious ^† 1	1/352 (0.28%)	0/348 (0.00%)
Pneumonia bacterial ^† 1	1/352 (0.28%)	0/348 (0.00%)
Lung infection ^† 1	1/352 (0.28%)	3/348 (0.86%)
Biliary tract infection ^† 1	0/352 (0.00%)	1/348 (0.29%)
Peritonitis bacterial ^† 1	0/352 (0.00%)	1/348 (0.29%)
Injury, poisoning and procedural complications
Compression fracture ^† 1	1/352 (0.28%)	1/348 (0.29%)
Femur fracture ^† 1	2/352 (0.57%)	0/348 (0.00%)
Fractured ischium ^† 1	1/352 (0.28%)	0/348 (0.00%)
Humerus fracture ^† 1	0/352 (0.00%)	1/348 (0.29%)
Jaw fracture ^† 1	0/352 (0.00%)	1/348 (0.29%)
Rib fracture ^† 1	1/352 (0.28%)	0/348 (0.00%)
Subarachnoid haemorrhage ^† 1	1/352 (0.28%)	0/348 (0.00%)
Toxicity to various agents ^† 1	0/352 (0.00%)	1/348 (0.29%)
Investigations
Alanine aminotransferase increased ^† 1	1/352 (0.28%)	0/348 (0.00%)
Aspartate aminotransferase increased ^† 1	1/352 (0.28%)	0/348 (0.00%)
Blood bilirubin increased ^† 1	1/352 (0.28%)	1/348 (0.29%)
Neutrophil count decreased ^† 1	0/352 (0.00%)	6/348 (1.72%)
Platelet count decreased ^† 1	0/352 (0.00%)	1/348 (0.29%)
Weight decreased ^† 1	1/352 (0.28%)	0/348 (0.00%)
White blood cell count decreased ^† 1	0/352 (0.00%)	1/348 (0.29%)
Metabolism and nutrition disorders
Dehydration ^† 1	5/352 (1.42%)	6/348 (1.72%)
Diabetic ketoacidosis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Hyperglycaemia ^† 1	0/352 (0.00%)	2/348 (0.57%)
Hypoalbuminaemia ^† 1	1/352 (0.28%)	0/348 (0.00%)
Hyponatraemia ^† 1	1/352 (0.28%)	1/348 (0.29%)
Malnutrition ^† 1	0/352 (0.00%)	1/348 (0.29%)
Decreased appetite ^† 1	39/352 (11.08%)	32/348 (9.20%)
Hypophagia ^† 1	1/352 (0.28%)	3/348 (0.86%)
Musculoskeletal and connective tissue disorders
Arthritis ^† 1	1/352 (0.28%)	1/348 (0.29%)
Back pain ^† 1	1/352 (0.28%)	0/348 (0.00%)
Pathological fracture ^† 1	0/352 (0.00%)	1/348 (0.29%)
Spinal column stenosis ^† 1	1/352 (0.28%)	0/348 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites ^† 1	0/352 (0.00%)	1/348 (0.29%)
Tumour pain ^† 1	1/352 (0.28%)	2/348 (0.57%)
Tumour haemorrhage ^† 1	3/352 (0.85%)	3/348 (0.86%)
Metastases to meninges ^† 1	5/352 (1.42%)	1/348 (0.29%)
Tumour associated fever ^† 1	0/352 (0.00%)	1/348 (0.29%)
Cancer pain ^† 1	1/352 (0.28%)	1/348 (0.29%)
Metastatic gastric cancer ^† 1	1/352 (0.28%)	0/348 (0.00%)
Nervous system disorders
Cerebral infarction ^† 1	0/352 (0.00%)	2/348 (0.57%)
Dementia ^† 1	0/352 (0.00%)	1/348 (0.29%)
Depressed level of consciousness ^† 1	0/352 (0.00%)	1/348 (0.29%)
Dizziness ^† 1	2/352 (0.57%)	0/348 (0.00%)
Dysarthria ^† 1	1/352 (0.28%)	0/348 (0.00%)
Headache ^† 1	1/352 (0.28%)	0/348 (0.00%)
Loss of consciousness ^† 1	0/352 (0.00%)	2/348 (0.57%)
Peripheral sensory neuropathy ^† 1	2/352 (0.57%)	0/348 (0.00%)
Presyncope ^† 1	0/352 (0.00%)	2/348 (0.57%)
Seizure ^† 1	0/352 (0.00%)	1/348 (0.29%)
Status epilepticus ^† 1	0/352 (0.00%)	1/348 (0.29%)
Syncope ^† 1	0/352 (0.00%)	1/348 (0.29%)
Embolic cerebral infarction ^† 1	0/352 (0.00%)	1/348 (0.29%)
Partial seizures ^† 1	0/352 (0.00%)	1/348 (0.29%)
Psychiatric disorders
Delirium ^† 1	0/352 (0.00%)	1/348 (0.29%)
Suicide attempt ^† 1	1/352 (0.28%)	0/348 (0.00%)
Mental disorder ^† 1	1/352 (0.28%)	0/348 (0.00%)
Renal and urinary disorders
Hydronephrosis ^† 1	4/352 (1.14%)	8/348 (2.30%)
Renal disorder ^† 1	0/352 (0.00%)	1/348 (0.29%)
Urinary tract obstruction ^† 1	0/352 (0.00%)	2/348 (0.57%)
Renal impairment ^† 1	0/352 (0.00%)	1/348 (0.29%)
Acute kidney injury ^† 1	0/352 (0.00%)	2/348 (0.57%)
Reproductive system and breast disorders
Adnexal torsion ^† 1	0/352 (0.00%)	1/348 (0.29%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	2/352 (0.57%)	3/348 (0.86%)
Hiccups ^† 1	0/352 (0.00%)	1/348 (0.29%)
Interstitial lung disease ^† 1	2/352 (0.57%)	0/348 (0.00%)
Pleural effusion ^† 1	1/352 (0.28%)	0/348 (0.00%)
Pneumonia aspiration ^† 1	1/352 (0.28%)	2/348 (0.57%)
Pulmonary embolism ^† 1	3/352 (0.85%)	4/348 (1.15%)
Skin and subcutaneous tissue disorders
Dermatomyositis ^† 1	0/352 (0.00%)	1/348 (0.29%)
Drug eruption ^† 1	0/352 (0.00%)	1/348 (0.29%)
Rash ^† 1	1/352 (0.28%)	0/348 (0.00%)
Vascular disorders
Embolism ^† 1	0/352 (0.00%)	2/348 (0.57%)
Infarction ^† 1	1/352 (0.28%)	0/348 (0.00%)
1 Term from vocabulary, MedDRA (ver. 21.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	TAS-118/Oxaliplatin	S-1/Cisplatin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	344/352 (97.73%)	328/348 (94.25%)
Blood and lymphatic system disorders
Anaemia ^† 1	94/352 (26.70%)	96/348 (27.59%)
Leukopenia ^† 1	14/352 (3.98%)	19/348 (5.46%)
Neutropenia ^† 1	50/352 (14.20%)	53/348 (15.23%)
Eye disorders
Lacrimation increased ^† 1	41/352 (11.65%)	37/348 (10.63%)
Gastrointestinal disorders
Abdominal pain ^† 1	46/352 (13.07%)	30/348 (8.62%)
Constipation ^† 1	80/352 (22.73%)	90/348 (25.86%)
Diarrhoea ^† 1	189/352 (53.69%)	134/348 (38.51%)
Dyspepsia ^† 1	20/352 (5.68%)	13/348 (3.74%)
Nausea ^† 1	200/352 (56.82%)	186/348 (53.45%)
Stomatitis ^† 1	148/352 (42.05%)	88/348 (25.29%)
Vomiting ^† 1	100/352 (28.41%)	70/348 (20.11%)
General disorders
Fatigue ^† 1	116/352 (32.95%)	106/348 (30.46%)
Malaise ^† 1	77/352 (21.88%)	76/348 (21.84%)
Oedema ^† 1	9/352 (2.56%)	26/348 (7.47%)
Oedema peripheral ^† 1	21/352 (5.97%)	27/348 (7.76%)
Pyrexia ^† 1	45/352 (12.78%)	32/348 (9.20%)
Investigations
Alanine aminotransferase increased ^† 1	45/352 (12.78%)	20/348 (5.75%)
Aspartate aminotransferase increased ^† 1	50/352 (14.20%)	19/348 (5.46%)
Blood creatinine increased ^† 1	6/352 (1.70%)	33/348 (9.48%)
Neutrophil count decreased ^† 1	90/352 (25.57%)	115/348 (33.05%)
Platelet count decreased ^† 1	103/352 (29.26%)	76/348 (21.84%)
Weight decreased ^† 1	78/352 (22.16%)	41/348 (11.78%)
White blood cell count decreased ^† 1	45/352 (12.78%)	76/348 (21.84%)
Blood alkaline phosphatase increased ^† 1	27/352 (7.67%)	10/348 (2.87%)
Metabolism and nutrition disorders
Hypoalbuminaemia ^† 1	40/352 (11.36%)	25/348 (7.18%)
Hypokalaemia ^† 1	19/352 (5.40%)	14/348 (4.02%)
Hyponatraemia ^† 1	7/352 (1.99%)	19/348 (5.46%)
Decreased appetite ^† 1	234/352 (66.48%)	216/348 (62.07%)
Nervous system disorders
Dizziness ^† 1	18/352 (5.11%)	34/348 (9.77%)
Dysgeusia ^† 1	112/352 (31.82%)	82/348 (23.56%)
Neuropathy peripheral ^† 1	21/352 (5.97%)	7/348 (2.01%)
Peripheral sensory neuropathy ^† 1	242/352 (68.75%)	54/348 (15.52%)
Respiratory, thoracic and mediastinal disorders
Hiccups ^† 1	19/352 (5.40%)	62/348 (17.82%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	11/352 (3.13%)	23/348 (6.61%)
Palmar-plantar erythrodysaesthesia syndrome ^† 1	60/352 (17.05%)	27/348 (7.76%)
Rash ^† 1	18/352 (5.11%)	19/348 (5.46%)
Skin hyperpigmentation ^† 1	63/352 (17.90%)	50/348 (14.37%)
Pigmentation disorder ^† 1	32/352 (9.09%)	17/348 (4.89%)
Vascular disorders
Vascular pain ^† 1	32/352 (9.09%)	9/348 (2.59%)
1 Term from vocabulary, MedDRA (ver. 21.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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

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

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.

Layout table for additonal information

Responsible Party:	Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT02322593
Other Study ID Numbers:	10056040
First Submitted:	December 12, 2014
First Posted:	December 23, 2014
Results First Submitted:	August 24, 2021
Results First Posted:	December 20, 2021
Last Update Posted:	December 20, 2021

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