UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038357 |
|---|---|
| Receipt number | R000043712 |
| Scientific Title | Additional S1 chemotherapy for patients underwent non curative ESD for gastric cancer:exploratory clinical trial |
| Date of disclosure of the study information | 2019/10/23 |
| Last modified on | 2025/04/26 14:55:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Additional S1 chemotherapy for patients underwent non curative ESD for gastric cancer:exploratory clinical trial
Acronym
Additional S1 chemotherapy for patients underwent non curative ESD for gastric cancer (SPEC trial)
Scientific Title
Additional S1 chemotherapy for patients underwent non curative ESD for gastric cancer:exploratory clinical trial
Scientific Title:Acronym
Additional S1 chemotherapy for patients underwent non curative ESD for gastric cancer (SPEC trial)
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of additional S-1 therapy for patients underwent non curative gastric ESD who refuse additional gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Relapse-free survival
Key secondary outcomes
overall survival, Disease specific survival, Rate of treatment continuation, Adverse event
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
8 courses of S-1 chemotherapy
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients underwent non curative ESD for gastric cancer who refuse additional gastrectomy
2) Age from 20 to 85 years old
3) European Cooperative Oncology Group(ECOG) performance status of 0 or 1
4) No previous treatment of chemotherapy or radiation therapy for any neoplasms
5) Enough oral intake
6) Preserved organ function as follows
1 neutrophile count >=1,500/mm3
2 hemoglobin >=8.0 g/dL
3 platelet count >=75,000/mm3
4 AST=<100 IU/L
5 ALT=<100 IU/L
6 total bilirubin =<2.0 mg/dL
7 creatinine clearance (CCr) >=40 mL/min
7) Written informed consent
Key exclusion criteria
1)Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shoter, except mucosal cancer treated by endoscopic resection
2) previous gastrectomy
3) Infection requiring systemic treatment
4) Women expecting pregnancy, in pregnancy, in possible pregnancy or in breast feeding
5) Male expecting partner's pregnancy
6) Severe mental disease
7) Under treatment by flucytosine, phenytoin, or warfarin potassium
8) Uncontrolled diabetes mellitus
9) severe lung disease (Interstitial pneumonia, severe emphysema and so on)
10) unstable angina or myocardial infarction within 6 months
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Sawai |
Organization
Takatsuki general hospital
Division name
Division of Gastroenterology
Zip code
569-1192
Address
1-3-13 Kosobe-cho, Takatsuki-city
TEL
072-681-3801
shiroaki23@gmail.com
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Sawai |
Organization
Takatsuki general hospital
Division name
Division of Gastroenterology
Zip code
569-1192
Address
1-3-13 Kosobe-cho, Takatsuki-city
TEL
072-681-3801
Homepage URL
shiroaki23@gmail.com
Sponsor or person
Institute
Takatsuki general hospital
Institute
Department
Personal name
Funding Source
Organization
Takatsuki general hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Medicine, Kyoto University
Japanese Red Cross Wakayama Medical Center
Kobe City Medical Center General Hospital
Hyogo Cancer Center
Gastrointestinal Center, SANO HOSPITAL
Akashi Medical Association Akashi Medical Center
Ise Red Cross Hospital
Kobe University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takatsuki general hospital
Address
1-3-13 Kosobe-cho, Takatsuki-city
Tel
072-681-3801
yuge.junko@aijinkai-group.com
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
| 2019 | Year | 10 | Month | 23 | 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
9
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043712
