Short Course Oncology Therapy - A study of adjuvant chemotherapy in colorectal cancer - SCOT study

Gastrointestinal Onkologisk Förening0 个研究点目标入组 9,500 人开始时间: 2012年3月6日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•Fully resected stage III colorectal cancer or 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;
•Within 10 weeks of surgery at time of randomisation;
•WHO PS= 0 or 1; aged > or = 18 years; life expectancy of greater than 5 years;
•CEA within normal limits.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Prior chemotherapy
•Prior abdomino-pelvic radiotherapy;
•Moderate/severe renal impairment (GFR <30ml/min);
•ANC<1.5 X10^9/L; Platelets <100 X 10^9/L;Hgb<9 g/dl;
•AST/ALT > 2.5 x ULN;
•Clinically significant cardiovascular disease;
•Pregnant or lactating women, or women of child bearing potential not using adequate contraception;
•Prior malignancy( other than adequately treated carcinoma in situ of the uterine cervix or squamous cell carcinoma of the skin), unless the disease free interval has been at least 5 years;
•Known dihydropyrimidine dehydrogenase deficiency (DPD).

发起方

Gastrointestinal Onkologisk Förening