Pilot Study of FOLFOX6 Plus Sir-Spheres® Microspheres (Chemo-radiotherapy) in Combination With Bevacizumab (Avastin) as a First Line Treatment in Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

Sirtex Medical6 个研究点分布在 1 个国家开始时间: 2008年7月1日最近更新: 2015年5月22日

适应症

试验速览

阶段: 2 期
状态: 撤回
发起方: Sirtex Medical
试验地点: 6
主要终点: Toxicity and safety

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically confirmed adenocarcinoma of the colon or rectum.
•Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent.
•ECOG performance status 0 -
•Adequate hematological, renal and hepatic function.

排除标准

•Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment.
•Any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. Central nervous system (CNS) metastases are not allowed.
•Previous radiotherapy delivered to the upper abdomen.
•Peripheral neuropathy > grade 1 (NCI-CTCv3).

结局指标

主要结局

Toxicity and safety

时间窗: from study entry until 28 days after last cycle of chemotherapy

次要结局

未报告次要终点

研究者

发起方

Sirtex Medical

申办方类型

Industry

研究点 (6)

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