NL-OMON54713招募中3 期
COLLISION trial - Colorectal liver metastases: surgery versus thermal ablation - a phase III prospective randomized controlled trial - COLLISION - Surgery versus ablation for colorectal liver metastases
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 637
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 tumor;
- •At least one CRLM size <= 3 cm eligible for both surgical resection and
- •thermal ablation (target lesions);
- •Additional unresectable CRLM should be <= 3 cm and ablatable (unresectable
- •Additional unablatable CRLM should be resectable (unablatable lesions);
- •Maximum number of CRLM 10;
- •Resection for resectable lesions considered possible obtaining negative
- •resection margins (R0) and preserving adequate liver reserve
- •Resectability and ablatability should be re-confirmed intra-operatively by US
- •plus full exploration for hepatic, peritoneal and regional lymph node
- •metastases;
- •Age >18 years;
- •Eastern Cooper ative Oncology Group performance status (ECOG) 0-2;
- •American Society of Anesthesiologists (ASA) grade 1-3;
- •Life expectancy of at least 12 weeks;
- •Written informed consent
排除标准
- •Pregnant or breast-feeding subjects. Women of childbearing potential must
- •have a negative pregnancy test performed within 7 days of the start of
- •Immunotherapy <= 6 weeks prior to the procedure;
- •Chemotherapy <= 6 weeks prior to the procedure;
- •Any surgical resection or focal ablative liver therapy for CRLM prior to
- •Severe allergy to contrast media not controlled with premedication;
- •Patients with only one or two small-size (0-3cm) and anatomically
- •deep-seated (defined as requiring major hepatectomy) CRLM in a single liver
研究者
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