UMIN-CTR Clinical Trial
| 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 (Ver. 6) |
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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 |
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| Condition | ||
| Condition | Advanced or recurrent gastric cancer | |
| Classification by specialty |
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| 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 |
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| Interventions/Control_1 | S-1 | |
| Interventions/Control_2 | ||
| Interventions/Control_3 | ||
| Interventions/Control_4 | ||
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| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 45 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 |
| 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 | |
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| Date of disclosure of the study information |
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| 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 |
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| Results date posted |
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| 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 |
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| Participant flow | Clinical trial discontinued due to sluggish accumulation of 6 registered cases |
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| Adverse events | none |
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| Outcome measures | Clinical trial discontinued due to sluggish accumulation of 6 registered cases |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded |
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| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015187 |
