gastric cancer with peritoneal metastasis or positive peritoneal cytology
Conditions
Interventions
intraperitoneal PTX 20 mg/m2, intravenous PTX 50 mg/m2 on days 1 and 8, S-1 80 mg/m2/day on days 1-14, q3 weeks
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven primary gastric adenocarcinoma 2) Peritoneal metastasis or positive peritoneal cytology 3) Adequate function of important organs (within 14 days before registration) NEU >=1,000/mm3 Hemoglobin >=8.0g/dL Platelet >=75,000/mm3 AST <=150U/L, ALT <=150U/L T-Bilirubin <=3.0mg/dL Creatinine clearance >=30mL/min 4) Eastern Cooperative Oncology Group performance status 0-2 5) Age >= 20, < 75 years 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Distal metastasis other than to the peritoneum, ovary and abdominal lymph nodes 2) Contraindication to S-1 or paclitaxel 3) Apparent infection or inflammation 4) Severe heart disease 5) Severe complication 6) Gastrointestinal tract bleeding requiring blood transfusion 7) Pregnancy, breast feeding or intention to become pregnant 8) Judged inappropriate for this trial for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival response rate negative conversion rate on peritoneal cytology | — |
Countries
Japan
Contacts
Public ContactHironori Ishigami
The University of Tokyo Hospital Department of Chemotherapy
Outcome results
None listed