NCT01891552已完成不适用
Observational Study on Second Line Treatment of Colorectal Liver Metastases (KRas wt) by Hepatic Intra-arterial Chemoembolization With Dc Beads 70-150 μm Microspheres Preloaded With Irinotecan 200 Mgr Plus Systemic Cetuximab
International Group of Endovascular Oncology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- time to progression
研究概览
简要总结
- The recently introduced chemoembolization has been considered to be a very attractive new method in terms of response in the treatment of liver metastases from colon cancer carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new embolization materials.
- An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in patients with liver metastases from colon cancer, who had been pretreated with 2 or more lines of chemotherapy.
- Since a greater activity was attained by a combination of Cetuximab and Irinotecan versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal Products (EMEA) has granted authorization to the use of Cetuximab in association with irinotecan in the treatment of irinotecan-refractory CRC-LM.
- In this study we want to collect data on on time to progression and tolerability using DEBIRI+Cetuximab in LM-CRC
详细描述
This is an observational study and the treatment is related to the experiences and economical availability of each center.
Primary objective: To collect data on time to progression (local and/or distant progression) after administration of Dc-Beads microspheres preloaded with Irinotecan 200 mgr via hepatic intra-arterial locoregional delivery (TACE) in/without association with standard weekly therapy with Cetuximab.
Secondary objectives: To collect data on tolerability of treatment and improvement of quality of life (Edmonton Symptom Assessment System (ESAS))
Treatment under observation :
Program A ( for all patients)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable hepatic metastases from colorectal carcinoma (CRC-LM)
- •Progression of disease after first line therapy containing Irinotecan completed at least one month previously
- •Performance status (PS) 0-2
- •Biochemistry parameters within normal limits (ALT and gamma glutamyl transpeptidase not exceeding three times the upper limit of normal, total bilirubin not exceeding 2.5 mg/ml)
- •Adequate information and subsequent written informed consent
- •Life expectancy > 3 months
- •Patients K-RAS wild type
排除标准
- •Extension of disease greater than 50% of the parenchymal liver (confirmed by CAT scan or MRI)
- •Brain metastases
- •Severe and confirmed vascular diseases
- •Other concomitant malignancies except for cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
- •Evidence of significant diseases such as uncontrolled diabetes, congestive heart failure, chronic renal insufficiency (CRI)
- •Known hypersensitivity reactions towards components of the study drugs
- •Pregnant or breastfeeding women or women of childbearing potential not making use of effective contraceptives
- •Family, psychological, social or geographical circumstances preventing the patient from undergoing follow-up and from complying with protocol procedures
- •Patients K-RAS mutant
结局指标
主要结局
time to progression
时间窗: one year
次要结局
- number of adverse events(4 months)
研究者
Giammaria Fiorentini
Dr.
International Group of Endovascular Oncology
研究点 (1)
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