Phase III study of S-1 plus intravenous and intraperitoneal paclitaxel versus S-1 plus cisplatin for gastric cancer with peritoneal metastasis

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: S‐1 plus intravenous and intraperitoneal paclitaxel S‐1 plus cisplatin CONDITION: gastric cancer with peritoneal metastasis PRIMARY OUTCOME: Overall survival SECONDARY OUTCOME: antitumor effect; safety 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
Epistemonikos ID: 9e2078fc83f60e27bec16efa9fa7a645d3987ad0
First added on: Aug 22, 2024