ISRCTN59757862已完成未知
SCOT - Short Course Oncology Therapy: a study of adjuvant chemotherapy in colorectal cancer by the CACTUS and QUASAR 3 Groups
HS Greater Glasgow and Clyde0 个研究点目标入组 6,088 人开始时间: 2007年8月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6,088
研究概览
简要总结
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29611518 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31852579 results (added 20/12/2019) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38865139/ Post hoc analysis (added 13/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 10/07/2014:
- •1. Fully resected stage III colorectal cancer or high-risk stage II disease (defined as T4 disease, perforation, obstruction, less than 10 nodes examined, poorly differentiated histology or venous invasion)
- •2. No evidence of metastatic disease
- •3. Within 11 weeks of surgery
- •4. World Health Organisation Performance Status (WHO PS) equals zero or one
- •5. Greater than or equal to 18 years of age
- •6. Life expectancy greater than 5 years
- •7. Written informed consent
- •8. Normal Carcinoembryonic Antigen (CEA)
- •9. Patients with rectal cancer will be eligible unless they have had pre-op (chemotherapy) radiotherapy or are scheduled for post-op (chemotherapy) radiotherapy. Such patients must have had Total Mesorectal Excision (TME) surgery with negative (RO) resection margins
- •Previous inclusion criteria:
- •1. Fully resected stage III colorectal cancer or high-risk stage II disease (defined as T4 disease, perforation, obstruction, less than 10 nodes examined, poorly differentiated histology or venous invasion)
- •2. No evidence of metastatic disease
- •3. Within eight weeks of surgery
- •4. World Health Organisation Performance Status (WHO PS) equals zero or one
- •5. Greater than or equal to 18 years of age
- •6. Life expectancy greater than five years
- •7. Written informed consent
- •8. Normal Carcinoembryonic Antigen (CEA)
- •9. Patients with rectal cancer will be eligible unless they have had pre-op (chemotherapy) radiotherapy or are scheduled for post-op (chemotherapy) radiotherapy. Such patients must have had Total Mesorectal Excision (TME) surgery with negative (RO) resection margins
排除标准
- •1. Previous chemotherapy
- •2. Previous abdomino-pelvic radiotherapy
- •3. Moderate/severe renal impairment (Glomerular Filtration Rate [GFR] less than 30 ml/min)
- •4. Absolute neutrophil count less than 1.5 x 10^9
- •5. Platelet count less than 100 x 10^9
- •6. Haemoglobin less than 9 g/dl
- •7. Liver function tests greater than 2.5 Upper Limit of Normal (ULN)
- •8. Clinically significant cardiovascular disease
- •9. Pregnancy/lactation or of childbearing potential not using adequate contraception
- •10. Previous malignancy
- •11. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency
- •In addition, for the 3-month randomisation point, only patients deemed to be fit to continue treatment will be randomised.
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