A randomized phase l study on TS-1+CDDP+CPT-11(IPS) therapy for patients with advanced/metastatic gastric cancer(HERBIS-4A) (OGSG 1106)

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: TS‐1:dosage 80mg/m2, take orally 3weeks, and 2 weeks rest CDDP:60mg/m2, the intravenous drip infusion on the 8 days CPT‐11:the intravenous drip infusion on the 8 and 22 days One course lasts 5 weeks (35 days) , repeat for a maximam of 6 courses. CONDITION: Gastric Cancer PRIMARY OUTCOME: maximum tolerated dose and recommended dose SECONDARY OUTCOME: Response Rate (RR); Incidence of adverse events INCLUSION CRITERIA: 1)gastric cancer proven histologically Cancers located within 2‐3cm of E‐G junction are eligible. 2)Unresectable advanced gastric cancer (Stage IV) Cancers with metastatic lymph nodes of para‐aortic a2 or b1 station are excluded. 3)with measurable lesions by RECIST version 1.1 4)HER2(‐) or unknown HER2 5)patients between 20 and 75 years old at registration 6)PS (ECOG) between 0 and 1 7)without prior chemotherapy and/or radiation therapy 8)without any ascites and/or thoracic fluid to be removed 9)without any brain metastasis 10)with a good condition of important organs within 14 days of registration a)WBC >= 3,500/mm3 b)neutrophil >= 2,000/mm3 c)platelet >= 100,000/mm3 d)AST/ALT < 100 IU/L < 200 IU/L for patients with liver metastasis e)total bilirubin < 1.5mg/dL f)serum creatinine <= 1.2mg/dL g)Creatinin clearance >= 60ml/min CC by Cockcroft‐Gault method is available 11)pati
Epistemonikos ID: 918ac58eaa2ee6e54e5d3cb8cbf650f0beeda201
First added on: Aug 22, 2024