UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007726 |
|---|---|
| Receipt number | 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 18:34:59 |
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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
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
Sponsor or person
Institute
Chiba University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009078
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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