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
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
- 否
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
研究点 (1)
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