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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-UMIN000027389 |
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Date of registration:
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19/05/2017 |
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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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Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
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Scientific title:
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Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology - Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology |
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Date of first enrolment:
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2017/05/19 |
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Target sample size:
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15 |
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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=R000031281 |
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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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Hirohiko Kuroda |
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Address:
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36-1 Nishi-cho, Yonago, Tottori
Japan |
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Telephone:
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0859-38-6567 |
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Email:
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kuroda-ttr@umin.ac.jp |
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Affiliation:
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Tottori University School of Medicine Division of Surgical Oncology |
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Name:
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Hirohiko Kuroda |
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Address:
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36-1 Nishi-cho, Yonago, Tottori
Japan |
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Telephone:
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0859-38-6567 |
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Email:
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kuroda-ttr@umin.ac.jp |
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Affiliation:
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Tottori University School of Medicine Division of Surgical Oncology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)The absence of metastasis to distant organ sites except the retroperitoneum, ovary and abdominal lymph nodes. 2)Contraindication to S-1 or paclitaxel. 3)Apparent infection or inflammation. 4)Sever heart disease. 5)Sever complication. 6)Gastrointestinal bleeding requiring blood transfusion repeatedly. 7)Pregnancy, breast feeding or intention to become pregnant. 8)Judeged inappropriate for this trial for other reasons.
Age minimum:
20years-old
Age maximum:
85years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Gastric cancer with peritoneal metastasis or positive peritoneal cytology.
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Intervention(s)
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S-1 was administered orally at a dose 80mg/m2/day for 14 consecutive days, followed by 7days of rest. PTX was administered intravenou at a dose of 50mg/m2 and intraperitoneal at a dose of 20mg/m2 on days 1 and 8.
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Primary Outcome(s)
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Safety
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Secondary Outcome(s)
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Disease control rate. three year overall survival. Progression free survival.
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Source(s) of Monetary Support
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Tottori University Hospital
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Ethics review
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Status: YES
Approval date: 01/05/2017
Contact:
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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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31/05/2022 |
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URL:
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