Intraperitoneal and intravenous paclitaxel plus S-1
- Conditions
- Gastric cancer with peritoneal metastasis or positive peritoneal cytology.
- Registration Number
- JPRN-jRCTs061180008
- Lead Sponsor
- Fujiwara Yoshiyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety(Adverse experience. Laboratory tests. Vital sign)
- Secondary Outcome Measures
Name Time Method 1) Disease control rate. <br>2) Three year overall survival. <br>3) Progression free survival.