UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013019 |
|---|---|
| Receipt number | 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 13:54:12 |
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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
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
k.ishido@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015187
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
