NL-OMON41313已完成不适用
Pilot study evaluating the feasibility of endoscopy guided fiducial marker placement for rectal cancer. - Endoscopy guided fiducial marker placement for rectal cancer.
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 20 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
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Histologically proven diagnosis of primary rectal adenocarcinoma
- •Treatment plan:
- •o 5x5 Gray (Gy) neoadjuvant radiotherapy followed by TME
- •* cT1-3N1 / cT3N0 with extramural invasion >5 mm
- •* Distance to mesorectal fascia >1 mm
- •o Chemoradiation consisting of 25 x 1,8 Gy combined with Capecitabine 825 mg/m2 twice daily followed by TME
- •* cT4 / cT2-3 with distance to mesorectal fascia <=1 mm
- •* cN2 / extramesorectal pathological lymph nodes
- •o 5x5 Gy RT followed by chemotherapy (with or without a subsequent TME)
- •* rectal cancer with resectable liver metastases
- •Written informed consent
排除标准
- •Coagulopathy (prothrombin time < 50% of control; partial thromboplastin time > 50 seconds) or anticoagulantia (marcoumar, sintrom or new oral anticoagulants) that cannot be stopped
- •Prior pelvic irradiation or surgery that may affect the placement of the markers
- •World health organization performance status 3-4
- •Pregnant women
- •Patients who underwent a hip replacement
- •Patients with a contraindication for MRI (e.g. pacemaker, metallic foreign body in the eye, cerebral aneurysm clips, claustrophobia)
研究者
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