EUCTR2007-003957-10-DE进行中（未招募）不适用
Short Course Oncology Therapy – A Study of Adjuvant Chemotherapy in Colorectal Cancer - SCOT
Greater Glasgow Health Board/University of Glasgow (GU)0 个研究点目标入组 9,500 人开始时间: 2012年12月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Fully resected stage III colorectal cancer*
- •Fully resected high-risk stage II colorectal cancer* (defined as having one or more of
- •the following - T4 disease, tumour obstruction and/or perforation of the primary tumour
- •during the pre-operative period, inadequate nodal harvest as indicated by <10 nodes
- •examined, poorly differentiated histology, perineural invasion, peritoneal involvement
- •or extramural venous/lymphatic invasion).
- •See tumour staging guideline in Appendix 11 for clarification on SCOT
- •eligibility.
- •No evidence of residual or metastatic disease.
- •Ideally patients should be randomised within 11 weeks of surgery and treatment should
- •start within 2 weeks of randomisation. However as long as the surgery to cycle 1
- •treatment start date is = 13 weeks the patient will be considered eligible.
- •WHO PS = 0 or 1.
- •Age >18 years.
- •Life expectancy >5 years with reference to non-cancer related diseases.
- •Written informed consent.
- •CEA = 1.2 X ULN (as per local values) (see Schedule of Assessments section 4.1
- •Baseline Evaluations for details).
- •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).
- •* All patients must have negative (R0) resection margins defined as greater than 1mm
- •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
排除标准
- •Previous chemotherapy*.
- •Previous long course chemoradiotherapy (pre-operative short course radiotherapy is
- •Moderate/severe renal impairment (GFR/Creatinine Clearance <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, or willing to use
- •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 (DPD) deficiency.
- •* No previous chemotherapy except chemotherapy administered with curative intent
- •completed more than 5 years ago and from which there are no residual complications.
研究者
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