Phase II trial of neo-adjuvant Oxaliplatin and 5-fluorouracil in esophageal cancer

Churchill Hospital0 个研究点目标入组 38 人开始时间: 2017年10月12日最近更新: 2018年8月27日

适应症

试验速览

•1. Histologically proven operable oesophageal adenocarcinoma/squamous cell carcinoma
•2. Age greater than or equal to 18 years
•3. Suitable for neo-adjuvant chemotherapy according to local protocols
•4. Subjects must be free of any clinically significant disease other than oesophageal cancer that would interfere with the study evaluations
•5. Adequate haematologic, renal and hepatic function as demonstrated by laboratory values performed within 14 days prior to the administration of chemotherapy:
•5.1. Absolute neutrophil count (ANC) = 1500/mm3
•5.2. Platelet count = 100,000/ mm3
•5.3. Haemoglobin = 10g/dL
•5.4. Urea and serum creatinine < 1.5 times upper limit of laboratory normal (ULN)
•5.5. Creatinine clearance: more than 50ml (by Cockcroft Gault calc)
•5.6. Total bilirubin < 1.5 times ULN
•5.7. AST = 3 times ULN
•5.8. Alkaline phosphatase < 2 times ULN
•6. Patients must have given written informed consent
•7. Women of child-bearing potential must use an acceptable method of birth control during the study

•1. Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to starting the study drug(s))
•2. Known dihydropyrimidine dehydrogenase deficiency
•3. Subjects known to be HIV, Hep B or Hep C positive

发起方

Churchill Hospital