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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007726
Receipt No. R000009078
Scientific Title S-1/CDDP and Lentinan for Advanced Stomach cancer
Date of disclosure of the study information 2012/04/10
Last modified on 2019/01/29

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Basic information
Public title S-1/CDDP and Lentinan
for Advanced Stomach cancer
Acronym SPLASH study
Scientific Title S-1/CDDP and Lentinan
for Advanced Stomach cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba graduate school of medicine
Division name Department of frontier surgery
Zip code
Address 1-8-1 Inohana,Chuo-ku,Chiba,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mikito Mori
Organization Chiba graduate school of medicine
Division name Department of frontier surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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