UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	S-1/CDDP and Lentinan for Advanced Stomach cancer
Title of the study (Brief title)	SPLASH study
Region	Japan

Condition
Condition	advanced gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of combination S-1/CDDP and Lentinan for Advanced Gastric cancer. To assess the rate of the completion of combination therapy of S-1/CDDP and Lentinan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes	feasibility,PFS,OS,TTF,RR,Clinical benefit rate(CBR),G/L,QOL

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TS-1+CDDP+Lentinan TS-1:80-120mg/day for 3weeks,followed by 2weeks rest period 35st 1 course. CDDP:60mg/m2 on day 8 each course. Lentinan:2mg/body/week on 1,8,15 day each course.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Confirmed adenocarcinoma 2)Evaluable lesion by RECIST version1.11 within 28 days 3)No previous treatment 4)Adequate organ fanction 5)PS(ECOG):0-2 6)Prognostic period >= 3 months from enrollment 7)20>=,<80 years old 8)Oral intakes is possible 9)Written informed consent
Key exclusion criteria	1)Serious drug hypersesitivity 2)Active infection 3)Clitical condition of heart disease 4)Serious coexisting illness diabetes mellitus,uncontrolled or controlled with insulin,liver cirrhosis,renal disfunction,severe pulmonary dysfunction,bowel dysfunction,history of myocardial infarction 5)Massive hydrothorax or ascites 6)Multiple bone metastases 7)Brain metastasis 8)Active bleeding of digestive tract 9)Diarrhea 10)Severe mental disorders 11)Have other cancers than gastric cancer 12)Pregnant or nursing 13)Pregnant or nursing 14)Not suitable for participating in the study for any other reason
Target sample size	20

Research contact person
Name of lead principal investigator	Hisahiro Matsubara
Organization	Chiba graduate school of medicine
Division name	Department of frontier surgery
Address	1-8-1 Inohana,Chuo-ku,Chiba,Japan
TEL
Email

Public contact
Name of contact person	Mikito Mori
Organization	Chiba graduate school of medicine
Division name	Department of frontier surgery
Address	1-8-1 Inohana,Chuo-ku,Chiba,Japan
TEL
Homepage URL
Email

Sponsor
Institute	Chiba University hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 07 Month 01 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 10 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009078