DRKS00030567招募中Unknown
Selective Neoadjuvant Therapy of Rectal Cancer Patients: SELREC - a randomized controlled, open, multicentre non-inferiority trial - SELREC
niversitätsklinikum Heidelberg; Klinik für Allgemein-, Viszeral- und Transplantationschirurgie0 个研究点目标入组 1,074 人开始时间: 2023年3月31日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 1,074
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Primary adenocarcinoma of the rectum <12cm from the anal verge
- •- T3 and/or N1 disease
- •- CRM >1mm (MRI based)
- •- No evidence of distant metastasis (M0)
- •- Age =18 years
- •- Ability of patient subject to understand character and individual consequences of the clinical trial
- •- Written informed consent
排除标准
- •- Patients who should not receive multimodal treatment for safety reasons
- •- Patients needing neoadjuvant treatment for sphincter preservation
- •- Previous radiotherapy to the small pelvis
- •- Patients with extensive lymph node spread (N2)
- •- Extramural vascular invasion or tumour deposits
- •- Participation in another interventional trial with interference of intervention and/or outcome of this trial
- •- Previous diagnosis of malignant disease except basal cell carcinoma
- •- Contraindications for MRI (e.g. non-MRI-compatible cardiac pacemaker)
- •- Pregnancy or lactation
- •- Any condition that could result in an undue risk for the patient based on the investigator’s assessment
研究者
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