Short Course Oncology Therapy(SCOT). A study of post operative chemotherapy for 12 weeks versus 24 weeks with oxaliplatin/Fluorouracil (5FU) to establish disease free survival outcomes in locally advanced colon cancer.

Australasian Gastrointestinal Trials Group (AGITG)0 个研究点目标入组 213 人开始时间: 2009年8月5日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Male or female patients with fully resected stage III colon cancer
•2. No evidence of residual or metastatic disease.
•3. Patients must be randomised within 10 weeks of surgery.
•4. World Health Organisation(WHO) Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1
•5. Life expectancy >5 years with reference to non-cancer related diseases.
•6 Written informed consent
•7. Carcinoembryonic Antigen (CEA) within normal limits

•1. Previous chemotherapy.
•2. previous abdomino-pelvic radiotherapy. 3. moderate/severe renal impairment, Glomerular Filtration Rate (GFR<30 ml/min) as calculated by the Cockcroft and Gault equation.
•4. absolute neutrophil count <1.5x109/L
•5. Platelet count <100x10 9/L
•6. Haemoglobin <9g/dL
•7. Aspartate aminotransferase/alanine aminotransferase > 2.5 x upper limit of normal.
•8. Clinically significant cardiovascular disease. (i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension.)
•9. Pregnancy/lactation or of child bearing potential and not using medically approved contraception.
•10. previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least 5 years.
•11. known or suspected dihydropyrimidine dehydrogenase deficiency (DPD)

发起方

Australasian Gastrointestinal Trials Group (AGITG)