SCOT - Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer - SCOT

HS Greater Glasgow and Clyde (NHSGG&C)/University of Glasgow (GU)0 个研究点目标入组 9,500 人开始时间: 2011年10月5日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Fully resected stage III colorectal cancer
•High-risk stage II disease (defined as T4 disease, tumour perforation, obstruction, inadequate nodal harvest as indicated by <10 nodes examined, poorly differentiated histology or extramural venous/lymphatic invasion).
•See tumour staging guideline in Appendix 11 for clarification on SCOT eligibility.
•No evidence of residual or metastatic disease.
•Patients must be registered/randomised within 10 weeks of surgery.
•WHO PS = 0 or 1.
•Age >18 years.
•Life expectancy >5 years with reference to non-cancer related diseases.
•Written informed consent.
•CEA within normal limits (as per local values).
•Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy. All rectal cancer patients included in the trial must have had TME type surgery with negative (R0) resection margins (R0 defined as greater than 1mm clearance).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Previous chemotherapy. [Not applicable to patients being randomised after 12 weeks of treatment].
•Previous abdomino-pelvic radiotherapy, with the exception of short course preoperative radiotherapy for rectal cancer.
•Moderate/severe renal impairment (GFR<30 ml/min), as calculated by the Cockcroft-Gault equation (Appendix 2).
•Absolute neutrophil count<1.5x109/L.
•Platelet count <100x109/L.
•Haemoglobin <9 g/dL.
•Aspartate aminotransferase/Alanine aminotransferase >2.5 x upper limit of normal (at least one of AST or ALT must be performed).
•Clinically significant cardiovascular disease. [i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association (NYHA – Appendix 4) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension].
•Pregnancy/lactation or of child bearing potential and not using medically approved contraception. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.)
•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.
•Known or suspected dihydropyrimidine dehydrogenase deficiency (DPD).

发起方

HS Greater Glasgow and Clyde (NHSGG&C)/University of Glasgow (GU)