gastric cancer with peritoneal metastasis
Conditions
Interventions
S-1 plus intravenous and intraperitoneal paclitaxel
S-1 plus cisplatin
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven primary gastric adenocarcinoma 2) Peritoneal metastasis confirmed by laparoscopy or diagnostic imaging 3) No or short-term (<2 months) prior chemotherapy 4) Adequate function of important organs (within 14 days before registration) Hemoglobin >=8.0g/dL WBC >= LLN, <12,000/mm3 Platelet >=100,000/mm3 T-Bilirubin <= ULN x 1.5 AST <=100U/L ALT <=100U/L Creatinine <= ULN 5) Eastern Cooperative Oncology Group performance status 0-1 6) Expected survival period of more than 3 months. 7) Age >=20, <75 8) Adequate oral intake 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Metastasis to distant organ sites other than the ovary 2) Contraindication to S-1, cisplatin or paclitaxel 3) Apparent infection or inflammation 4) Severe heart disease 5) Severe complication 6) Massive ascites requiring drainage for palliation 7) Gastrointestinal tract bleeding requiring blood transfusion 8) Severe diarrhea (more than 4 times a day and/or watery) 9) Psychiatric disorder requiring medication 10) Other active concomitant malignancies 11) Pregnancy, breast feeding or intention to become pregnant 12) Judged inappropriate for this trial for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| antitumor effect safety | — |
Countries
Japan
Contacts
Public ContactHironori Ishigami
The University of Tokyo Hospital Department of Chemotherapy
Outcome results
None listed