跳至主要内容
临床试验/NCT05871762
NCT05871762招募中不适用

Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer-a National Multi-center, Prospective, Real World Study

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 3,705 人开始时间: 2023年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,705
试验地点
1
主要终点
3-year OS

研究概览

简要总结

The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • pathologically confirmed rectal adenocarcinoma
  • located within 12cm below the anal verge

排除标准

  • diagnosed with distant metastasis
  • multiple primary colorectal cancers
  • history of previous malignant tumors
  • Pregnant or lactating women

结局指标

主要结局

3-year OS

时间窗: 3 years

3-year overall survival

次要结局

  • 3-year DFS(3 years)
  • 3-year LR(3 years)
  • adjuvant therapy rate(at the time point of 3-year follow up)
  • EUS/MRI assessment rate(at the time point of surgery of the primary lesion)
  • 3-year distant metastasis rate(3 years)
  • neoadjuvant therapy rate(at the time point of surgery of the primary lesion)
  • R0 resection rate(at the time point of surgery of the primary lesion)
  • CCR(immediately after the completion of neoadjuvant therapy assessment)
  • pCR(immediately after the completion of surgery)
  • 30-day mortality(30 days after the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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