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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013019
Receipt No. R000015187
Scientific Title Phase 2 study of alternate-day administrations of S-1 in elderly patients with advanced/recurrent gastric cancer (KDOG 1301)
Date of disclosure of the study information 2014/01/30
Last modified on 2020/08/05

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Basic information
Public title Phase 2 study of alternate-day administrations of S-1 in elderly patients with advanced/recurrent gastric cancer (KDOG 1301)
Acronym Phase 2 study of alternate-day administrations of S-1 in elderly patients with gastric cancer (KDOG 1301)
Scientific Title Phase 2 study of alternate-day administrations of S-1 in elderly patients with advanced/recurrent gastric cancer (KDOG 1301)
Scientific Title:Acronym Phase 2 study of alternate-day administrations of S-1 in elderly patients with gastric cancer (KDOG 1301)
Region
Japan

Condition
Condition Advanced or recurrent gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1
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
76 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Unresectable advanced or recurrent gastric carcinoma which was confirmed histologically
2. negative or non-measurement of HER2
3. Patient with the measurable lesion
4. 76 years or older
5. ECOG performance status: 0-2
6. Chemo-naive patient
7. Sufficient organ functions in laboratory data within 14 days before enrollment
8. Possible of oral ingestion
9. Written informed consent
Key exclusion criteria 1. History of hypersensitivity for S-1 or ingredients of S-1
2. Patient who takes flucytosine, or phenytoin
3. Severe bone marrow suppression, severe renal dysfunction, or severe liver dysfunction
4. Severe concomitant disease (congestive heart failure, hemorrhagic peptic ulcer, ileus, symptomatic ischemic heart disease, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or etc)
5. Patient who suffered from myocardial infarction or cerebral infarction within six months
6. symptomatic brain metastasis
7. Severe mental disorders
8. Active synchronous malignancy
9. Watery diarrhea
10. HBV carrier who has to take nucleotide analogues (e.g. Entecavir) during chemotherapy
11. Patient who is judged inappropriate for the entry into this study by the investigator
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Wasaburo
Middle name
Last name Koizumi
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code 2520374
Address 1-15-1, Kitazato, Minami-ku, Sagamihara, Kanagawa, 252-0380 Japan
TEL 042-778-8111
Email koizumi@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Ishido
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1, Kitazato, Minami-ku, Sagamihara, Kanagawa, 252-0380 Japan
TEL 042-778-8111
Homepage URL
Email k.ishido@kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology, Kitasato University School of Medicine
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 Kitasato University School of Medicine Hospital Ethic Comittee
Address 1-15-1, Kitazato, Minami-ku, Sagamihara, Kanagawa, 252-0380 Japan
Tel 042-778-9111
Email rinrib@med.kitasato-u.ac.jp

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
2014 Year 01 Month 30 Day

Related information
URL releasing protocol none
Publication of results Published

Result
URL related to results and publications clinical trial discontinued
Number of participants that the trial has enrolled 6
Results Clinical trial discontinued due to sluggish accumulation of 6 registered cases
Results date posted
2020 Year 08 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Clinical trial discontinued due to sluggish accumulation of 6 registered cases
Participant flow Clinical trial discontinued due to sluggish accumulation of 6 registered cases
Adverse events none
Outcome measures Clinical trial discontinued due to sluggish accumulation of 6 registered cases
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 21 Day
Date of IRB
2014 Year 01 Month 21 Day
Anticipated trial start date
2014 Year 01 Month 30 Day
Last follow-up date
2018 Year 01 Month 30 Day
Date of closure to data entry
2018 Year 01 Month 30 Day
Date trial data considered complete
2018 Year 01 Month 30 Day
Date analysis concluded
2018 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 30 Day
Last modified on
2020 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015187

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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