JRCT ID: jRCTs061180008
Registered date:07/12/2018
Intraperitoneal and intravenous paclitaxel plus S-1
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Gastric cancer with peritoneal metastasis or positive peritoneal cytology. |
Date of first enrollment | 19/05/2017 |
Target sample size | 50 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | S-1 was administered orally at a dose 80mg/m2/day for 14 consecutive days, followed by 7 days of rest. PTX was administered intravenous at a dose of 50mg/m2 and intraperitoneal at a dose of 20mg/m2 on days 1 and 8. |
Outcome(s)
Primary Outcome | Safety(Adverse experience. Laboratory tests. Vital sign) |
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Secondary Outcome | 1) Disease control rate. 2) Three year overall survival. 3) Progression free survival. |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | < 85age old |
Gender | Both |
Include criteria | 1) histologically proven primar gastric adenocarcinoma. 2) Peritneal metastasis and/or cancer cells on peritoneal cytology. 3) Patients with following adequate function of important organs at screening period. Neutrocyte >= 1,000/mm3 Hemoglobin >= 8.0g/dl Platelet >= 75,000/mm3 AST, ALT < 150U/L Total Bilirubin <= 3.0mg/dL Creatinine clearance >= 30ml/min 4) Eastern Cooperative Oncology Group performance status 0-2 5) Age >= 20, < 85 years 6) Written informed consent. |
Exclude 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)Inappropriate for this trial for other reasons. |
Related Information
Primary Sponsor | Fujiwara Yoshiyuki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000027389 |
Contact
Public contact | |
Name | Kozo Miyatani |
Address | 36-1 Nishi-cho, Yonago, Tottori Tottori Japan 683-8504 |
Telephone | +81-859-38-6567 |
kozo5963@tottori-u.ac.jp | |
Affiliation | Tottori University Hospital |
Scientific contact | |
Name | Yoshiyuki Fujiwara |
Address | 36-1 Nishi-cho, Yonago, Tottori Tottori Japan 683-8504 |
Telephone | +81-859-38-6567 |
y-fujiwara@med.tottori-u.ac.jp | |
Affiliation | Tottori University Hospital |