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临床试验/ISRCTN98405441
ISRCTN98405441已完成3 期

A comparison of 5-FU and leucovorin treatment as bolus injection or continuous infusion in the adjuvant therapy of Dukes' B, C and radically operated D colorectal cancer: a randomized phase III trial studying toxicity, cost-benefit and quality of life in bolus injection and continuous infusion treatment regimens, effects of nutrition and nutritional support, changes in bacterial flora and prognostic factors

Helsinki University Central Hospital (Finland)0 个研究点目标入组 450 人开始时间: 2012年7月16日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
450

研究概览

简要总结

2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17895895 results 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32790589/ post-hoc analysis (added 17/08/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34359796/ Lead Time and Prognostic Role of Serum CEA, CA19-9, IL-6, CRP, and YKL-40 after Adjuvant Chemotherapy in Colorectal Cancer (added 09/08/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged 18 to 75 years
  • 2. Had histologically confirmed radically operated stage II-IV colorectal cancer (CRC)
  • 3. WHO performance status 0 ? 2 and adequate bone marrow, kidney and liver function

排除标准

  • 1. Presence of other invasive cancer than CRC in history except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer
  • 2. Metabolic, neurological or psychiatric illness that was incompatible with chemotherapy
  • 3. Serious thromboembolic event currently under treatment
  • 4. Pregnancy, lactation or absence of adequate contraception in fertile patients

研究者

发起方
Helsinki University Central Hospital (Finland)

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