NL-OMON44162已完成不适用
Follow up and functional outcome of organ saving treatment in patients with good response to neo-adjuvant (chemo)radiation - Functional outcome W&S
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 250 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*1. > 18 years old
- •2. Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response :
- •2A. Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI)
- •2B. Very good response (ycT1-2N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI). These patients will undergo a TEM to resect the small residual tumor
- •3. Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient
- •4. Choosing for the organ-saving treatment option (wait&see policy or TEM)
- •5. Informed consent
排除标准
- •1. Unable to understand or read Dutch
- •2. Unwilling to comply to the questionnaires or manometric measurement.
研究者
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