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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-UMIN000017652 |
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Date of registration:
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22/05/2015 |
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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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A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer
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Scientific title:
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A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer - A phase II study of preoperative DOS for cStage III gastric cancer |
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Date of first enrolment:
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2015/05/25 |
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Target sample size:
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50 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020456 |
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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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Yukinori
Kurokawa |
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Address:
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2-2-E2, Yamadaoka, Suita, Osaka, Japan
565-0871
Japan |
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Telephone:
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06-6879-3251 |
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Email:
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ykurokawa@gesurg.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Department of Gastroenterological Surgery |
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Name:
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Yukinori
Kurokawa |
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Address:
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2-2-E2, Yamadaoka, Suita, Osaka, Japan
Japan |
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Telephone:
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06-6879-3251 |
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Email:
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ykurokawa@gesurg.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Department of Gastroenterological Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Past history of severe hypersensitivity to drugs. 3) Active infection. 4) Severe complications (interstitial pneumonia, pulmonary fibrosis, renal failure, liver failure, heart failure, uncontrollable diabetes millutus and Uncontrollable hypertension) 5) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason. 6) Edema of limbs and trunk by any reason. 7) Continuous systemic steroid therapy. 8) Under treatment with flucytosine, phenytoin, or warfarin. 9) Abnormal electrocardiogram or severe cardiovascular disease. 10) Severe diarrhea. 11) Positive HBs antigen. 12) Pregnant women, or women with the possibility of the pregnancy and men who want let to pregnancy.
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Gastric cancer
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Intervention(s)
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preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1
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Primary Outcome(s)
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3-year progression-free survival
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Secondary Outcome(s)
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Overall survival, Progression-free survival, Response rate of preoperative chemotherapy, Pathological response rate, R0 resection rate, Proportion of adverse events.
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Source(s) of Monetary Support
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Yakult Honsha
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Ethics review
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Status: YES
Approval date: 18/05/2015
Contact:
rinri@hp-crc.med.osaka-u.ac.jp
IRB, Osaka University Hospital
06-6210-8295
rinri@hp-crc.med.osaka-u.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2024 |
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URL:
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