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 2023/11/08 22:32:45

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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

Email

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


Email

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


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

Email

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

2023 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043712


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name