NCT01165346已完成2 期
Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- non-progression part
研究概览
简要总结
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.
详细描述
Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Primitive liver cancer (hepatocellular carcinoma), proved by histology or diagnostic according to BCLC criteria
- •T1-3 N0 M0
- •With only one intra hepatic lesion and dimensions between 1 cm and 6 cm (IRM or hepatic scanner)
- •Stereotaxic radiotherapy treatment approved in multidisciplinary consultation, the patient being rejected for standard therapeutic
- •Age >= 18 ans
- •Previous anti tumoral treatment allowed but suspended since at least 15 days before the inclusion
- •OMS =< 2
- •Portal thrombosis allowed
- •Portal high blood pressure allowed
- •No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation
- •In case of underlying cirrhosis, only the Child-Pugh A is allowed
- •Life expectancy >= 12 weeks
- •Women must have an active contraception during all the study
- •Patient affiliated to health insurance
- •Patient must sign the consent
排除标准
- •Cirrhosis Child B and C
- •Hepatic lesion < 1 cm or > 6 cm
- •2 hepatic lesions or more
- •Recurrent or metastatic disease
- •Patient already included in another therapeutic trial with an experimental molecule
- •Allergy to gold
- •Pregnant women or susceptible to be pregnant or breastfeeding
- •Unable for medical follow-up (geographic, social or mental reasons)
研究组 & 干预措施
Stereotaxic radiation by CyberKnife
Experimental
Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days
干预措施: CyberKnife (Radiation)
Stereotaxic radiation by CyberKnife
Experimental
Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days
干预措施: Fiducials (Radiation)
结局指标
主要结局
non-progression part
时间窗: Up to 18 months
Percentage of non-progression 18 months after treatment, according to RECIST criteria
次要结局
- median time without progression(Up to 5 years after treatment)
- Quality of life(Up to 18 months after treatment)
- Medical costs(During the first 3 months)
- hepatic non progression part(Up to 3, 6, 9, 12 months)
- Biological response(Up to 3, 6, 9 months)
- Best response(Up to 5 years after treatment)
- acute and late tolerance(Up to 5 years after treatment)
- tumor evaluation(Up to 5 years after treatment)
研究者
研究点 (4)
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