Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 9
- 主要终点
- Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)
研究概览
简要总结
Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it. The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis.
详细描述
Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it.
The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis.
This can be problematic in patients with respiratory failure for which surgical treatment has been challenged. Radiofrequency pulmonary developed as a therapeutic alternative, it has the advantage of being performed in a session with less toxicity in the lung parenchyma
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
- •Patients over 18 years
- •Histological diagnosis of non-small cell lung tumor established.
- •Stage 1A tumors (lesions <= 3 cm, N0) report prepared by PET and CT
- •Surgical treatment of the lesion contrindiqué or refused by the patient,
- •ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP)
- •Expectancy greater than 6 months life
- •PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV> = 2.5) at the lesion to be treated,
- •Signed informed consent,
- •Patient affiliated to a social security scheme.
排除标准
- •Location of the lesion does not allow achieving ablathermy under satisfactory conditions: lesion contiguous to the major anatomical structures of the mediastinum, hilar location (less than 1 cm from the hilum)
- •Disorder of uncontrolled bleeding (TP <50% TCA> 1.5 x control).
- •Abnormal blood count platelets <90000/mm3
- •Cons-indication to general anesthesia
- •Patient with a cardiac pacemaker if a review indicates treatment against ARF
- •Patient included in another clinical study
- •Unable to undergo medical monitoring test for geographical, social or psychological reasons,
- •Private patient freedom and major subject of a measure of legal protection or unable to consent.
研究组 & 干预措施
Radiofrequency ablathermy
Percutaneous radiofrequency ablation (RFA)
干预措施: Percutaneous radiofrequency ablation (RFA) (Procedure)
结局指标
主要结局
Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)
时间窗: one year after percutaneous radiofrequency ablation (RFA)
local control is defined as the absence of progression of the ablated site. rate is defined as the number of alive patient without local progression divided by the number of patients alive at one year.
次要结局
- 3-year Overall Survival (OS) Rate(3 years after RFA)
- Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)(three years after percutaneous radiofrequency ablation (RFA))
- 1-year Overall Survival (OS) Rate(1 year after RFA)