SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 18
- 主要终点
- Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
研究概览
简要总结
The purpose of this study is to evaluate local disease control after 2 years in patients with non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy.
Eligible patients will be recruited and registered consecutively (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 4 years.
The number of patients required in this multicentric prospective study is 120:
- 20 patients in the SBRT-1 arm (cyberknife),
- 80 patients in the SBRT-2 arm (linear accelerator-based)
- 20 patients in the conformational radiotherapy arm.
This is a prospective, multicentric, non comparative and non randomized study.
详细描述
The main objective of this study is to do a health economic evaluation of innovating techniques in radiotherapy.
SBRT is the very precise delivery of high-powered radiation to small target volumes, using multiple low-intensity beams. Extremely precise patient positioning and target location is essential for accurate treatment delivery.
Several studies have shown a benefit of SBRT in terms of local control and progression-free survival, in particular for the treatment of cerebral metastases of limited number and size.
The development of this technique is recent. The number of treatment sessions is low: 1 to 4.
But the patient is exposed to a major risk of toxicity in several organs: the bronchi, the lungs, large vessels, the oesophagus and the spinal-cord.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Non-operated non-small-cell lung cancer (NSCLC) (inoperable tumor or patient refusal of surgery)
- •cytologically or histologically proven NSCLC Or
- •primitive pulmonary tumor of unproven malignancy
- •macroscopically normal bronchial endoscopy, negative cytology and biopsies
- •AND size increase on 2 successive scans (at 10-12 weeks interval)
- •AND hypermetabolic PET-CT pattern
- •AND absence of other proven etiology
- •Tumor < 5cm, distant (> 1.5 cm) from large vessels, principally in the bronchus and spinal-cord
- •No metastasis: M0
- •No lymph node involvement: N0
- •Functional respiratory evaluation (FRE) compatible with thoracic irradiation
- •Maximum expiratory flow-volume > 30% theoretical value
- •Age >= 18
- •ECOG PS <= 2
- •Female patients of childbearing potential: effective method of contraception
- •Written advice of the RCP (conciliation meeting) present in the patient file
- •Mandatory affiliation with a social security system
- •Written, signed informed consent
排除标准
- •Previously operated tumors
- •Previous thoracic irradiation
- •Previous or concurrent primary malignancies at other sites (except basocellular skin cancer or cervical cancer in situ or complete remission for more than 5 years)
- •Life expectancy < 6 months
- •Pregnant or lactating woman
- •Difficult follow-up
- •Patient deprived of freedom
结局指标
主要结局
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
时间窗: 2 years
次要结局
- Health economic evaluation of the various methods used for stereotactic radiotherapy(during treatment / post treatment)
- Prospective evaluation of acute and late toxicities of SBRT(M1, M3, M6, M12, M18 and M24)
- Study of quality of life in the 3 groups(inclusion, M1, M3, M12)
- Evaluation of progression-free survival and overall survival in the 3 groups(No time)