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临床试验/NL-OMON52908
NL-OMON52908招募中不适用

COLLISION-XL trial: Unresectable colorectal liver metastases: stereotactic body radiotherapy versus microwave ablation - a phase II prospective randomized controlled trial for CRLM 3-5 cm - COLLISION XL - SBRT vs MWA for unresectable CRLM 3-5 cm

Radiologie en nucleaire geneeskunde0 个研究点目标入组 68 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
68

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

  • Histological documentation of primary colorectal tumour;
  • 1-3 unresectable CRLM size 3-5 cm eligible for both MWA and SBRT (target
  • Additional unresectable CRLM < 3 cm should be ablatable;
  • Additional unablatable CRLM should be resectable;
  • No or limited extrahepatic disease (1 extrahepatic lesion is allowed, not
  • including positive para-aortal lymph nodes, celiac lymph nodes, adrenal
  • metastases, pleural carcinomatosis or peritoneal carcinomatosis);
  • Maximum number of total CRLM is 5 if there is extrahepatic disease and 10 if
  • there is no extrahepatic disease;
  • Unsuitable for (further) chemotherapy regimens
  • Resection for resectable lesions considered possible obtaining negative
  • resection margins (R0) and preserving adequate liver reserve
  • Previous radiotherapy, surgical resection or focal ablative therapy for CRLM
  • prior to inclusion are allowed;
  • Age >18 years;
  • Written informed consent

排除标准

  • Pregnant or breast-feeding subjects;
  • Immunotherapy <= 6 weeks prior to the procedure;
  • Chemotherapy <= 6 weeks prior to the procedure;
  • Severe allergy to contrast media not controlled with premedication;

研究者

发起方
Radiologie en nucleaire geneeskunde

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