Randomized phase II study of TS-1/CPT-11 versus TS-1/TXL in advanced/recurrent gastric cancer

The requested reference [dad7e44da6af212dea959801e6b64b5cc6980c2f] no longer exists in our database. It has been replaced by the current reference: [4262e9377fe36e531703a7bc975649e1c1359b9b]

Authors
Category Primary study
Year 2007
INTERVENTION: Group A: TS‐1(80mg/m2/day, between day 1 and 21) + CPT‐11(80mg/m2/day, on day and day 15 ) are administered in every 5 weeks (1 course). Group B: TS‐1(80mg/m2/day between day 1 and 14) + Taxol(50mg/m2/day, on day 1 and 8 ) are administered in every 3 weeks (1 course). CONDITION: advanced/recurrent gastric cancer PRIMARY OUTCOME: Response Rate(RECIS) SECONDARY OUTCOME: 1.Progression free survival (PFS); 2.Overall survival (OS); 3.Adverse Events INCLUSION CRITERIA: 1) Diagnosed gastric cancer, histologically 2)with metastatic lesions which can be measured 3) without any prior radiation therapy or chemotherapy using CPT‐11, TXL or TS‐1 4) Performance Status 0 – 2 in ECOG classification 5) age 20<= and =>75 6) sufficient oral intake 7) Survival period is expected over three months. 8) without any sever disorders in any organs 1. bone marrow function . WBC: 4,000/mm3<= and > 12,000/mm3 . Neutrocyte: 2,000 /mm3<= . Hb: 8.0 g/dl <= . Platelet: 100,000/mm3<= 2. Liver function . Total Bil.: 1.5 mg>= . GOT, GPT: < 100 IU/l 3 Renal Function . Creatinin: 1.2 mg/dl>= . Creatinin Clearance: 50 mg/mm <= (by Cockcroft‐Gault) 9) Written Informed Consents
Epistemonikos ID: 985a03e72930261173c32a8a0f7edcfee2799144
First added on: Aug 21, 2024