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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000006757 |
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Date of registration:
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22/11/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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S-1/trastuzumab for elderly HER2 positive advanced gastric cancer-Pilot study-
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Scientific title:
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S-1/trastuzumab for elderly HER2 positive advanced gastric cancer-Pilot study- - S-1/trastuzumab for elderly HER2 positive advanced gastric cancer-Pilot study- |
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Date of first enrolment:
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2011/12/01 |
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Target sample size:
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20 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007990 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Sachio Fushida |
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Address:
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13-1 Takara-machi, Kanazawa
Japan |
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Telephone:
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076-265-2362 |
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Email:
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fushida@staff.kanazawa-u.ac.jp |
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Affiliation:
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Kanazawa University Hospital Gastroenterological Surgery |
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Name:
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Takashi Fujimura |
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Address:
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13-1 Takara-machi, Kanazawa
Japan |
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Telephone:
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076-265-2362 |
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Email:
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tphuji@staff.kanazawa-u.ac.jp |
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Affiliation:
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Kanazawa University Hospital Gastroenterological Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Forbidden case to use S-1 and Trastuzumab 2) Infection or inflammatory case 3) Cardiovascular disease (congestive heart failure, Myocardial infarction, Ischemic heart disease, vulver disease) 4) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc. 5) Severe ascites and/or pleural effusion 6) Multiple bone metastasis 7) Clinical suspicion or previous history of metastasis to brain or meninges 8) Active digestive bleeding required repeat blood transfusion 9) severe diarrhea (4 times over /day) 10) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage 11) Complicated other active cancer 12) patient who want to be pregnant and /or pregnant woman 13) Intend to make pregnant 14) Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Age minimum:
75years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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untreated HER2 positive advanced gastric cancer
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Intervention(s)
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S-1+trastuzumab (S-1 80mg/m2 d1-28 and trastuzumab 8 or 6 mg/kg q3w)
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Primary Outcome(s)
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frequency and degree of adversed events
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Secondary Outcome(s)
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Overall survival, Progression free survival, Overall response rate
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Source(s) of Monetary Support
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Digestive Desease Support Organization
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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