NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180008

Registered date:07/12/2018

Intraperitoneal and intravenous paclitaxel plus S-1

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedGastric cancer with peritoneal metastasis or positive peritoneal cytology.
Date of first enrollment19/05/2017
Target sample size50
Countries of recruitment
Study typeInterventional
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 OutcomeSafety(Adverse experience. Laboratory tests. Vital sign)
Secondary Outcome1) Disease control rate. 2) Three year overall survival. 3) Progression free survival.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 85age old
GenderBoth
Include criteria1) 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 criteria1)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

Contact

Public contact
Name Kozo Miyatani
Address 36-1 Nishi-cho, Yonago, Tottori Tottori Japan 683-8504
Telephone +81-859-38-6567
E-mail 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
E-mail y-fujiwara@med.tottori-u.ac.jp
Affiliation Tottori University Hospital