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临床试验/NL-OMON41313
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

发起方
Antoni van Leeuwenhoek Ziekenhuis

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