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临床试验/ACTRN12605000792628
ACTRN12605000792628已完成不适用

Pilot study to assess safety and efficacy of a single implantation of SIR-Spheres plus systemic chemotherapy with 5-fluorouracil, leucovorin and irinotecan in patients with non-resectable liver metastases from primary adenocarcinoma of the large bowel

Sirtex Medical Limited0 个研究点目标入组 12 人开始时间: 2005年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12

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
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 ot stated(—)
性别
All

入选标准

  • Histologically confirmed primary adenocarcinoma of the large bowelCT evidence of metastases in the liverLiver metastases not treatable by some form of local ablation. Prior treatment with 5FU based chemotherapy permissible for the irinotecan alone armAdequate haematological, renal and hepatic functionWHO performance status 0-2Willing and able to provide written informed consent.

排除标准

  • Pregnant or breast feedingEvidence of ascites, cirrhosis or portal hypertension as determined by clinical assessmentCNS metastasesPrevious radiotherapy to the liverimmeasurable or unevaluable metastases to the liverHepatic arterial anatomy that will prevent administration of SIR-Spheres>20% atreriovenous lung shuntingTreatment with capecitabine within 8 weeks of SIRT.

研究者

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