Risk Adapted Free Flattering Filter Based Stereotactic Ablative Radiotherapy (Sabr) in Stage i Nsclc and Lung Metastases
试验速览
- 阶段
- 2 期
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- probability of not suffering a grade 3 or higher toxicity
研究概览
简要总结
This study is designed to evaluate the safety of Stereotactic Ablative Radiotherapy (SBRT) in selected patients with stage I Non Small Cell Lung Cancer (NSCLC) or metastatic lung cancer to demonstrate the feasibility and risks of using an ablative dose-adapted scheme with FFF beams. Other aims are To evaluate the incidence of acute and late complications; To evaluate tumour response to local radiation therapy by means of CT, PET/TC and MRI and To evaluate the impact of local therapy on overall and disease-free survival.
详细描述
The intervention (dose and fractions) depends on topographical parameters: lung disease (primary, peripheral nodes or mediastinal nodes), distance to chest wall, tumour size and distance to main bronchus.
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
- •Histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive PET/CT suggestive for primary tumour(SUV MAX> 4).
- •Tumour size < 5 cm in diameter prior to treatment.
- •Medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery.
- •Life expectancy of >12 months.
- •Criterion for medical inoperability include:
- •Overall clinical assessment at the UCLA thoracic tumour board. Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below: Minor Criteria: Age > 75, FEV1 51- 60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF < 40% or less), resting or exercise arterial pO2 < 55 mmHg, and pCO2 > 45 mmHg.
- •Age > 18 years.
- •Barthel score >40
- •Baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment.
- •If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Prior thoracic radiation treatment wich dose contribution can be expected in the new SBRT plan.
- •More than two lesions per lobe.
- •Active infections requiring systemic antibiotics.
- •Age <18 years old.
- •Barthel Total Score < 40.
研究组 & 干预措施
A. 34 Gy in a single fraction
34 Gy by single fraction Risk-adapted radiation dose.
干预措施: 34 Gy in a single fraction (Radiation)
B. 54Gy (18Gy/fr. x 3 fractions)
54Gy administered in 3 fraction of 18 Gy, risk adapted radiation dose
干预措施: 54Gy 18Gy/fr. x 3 fractions (Radiation)
C. 50Gy (12 x 5 fr.s)
54Gy administered in 5 fraction of 12 Gy, risk adapted radiation dose
干预措施: 60Gy (12 x 5 fr.s) (Radiation)
D. 60Gy (7.5Gy x 8fr.)
60 Gy administered in 8 fraction of 7.5 Gy, risk adapted radiation dose
干预措施: 60Gy (7.5Gy x 8fr.) (Radiation)
结局指标
主要结局
probability of not suffering a grade 3 or higher toxicity
时间窗: one year
Patients will be follow-up during one year. If patient suffered any toxicity grade 3 or higher during this period it will be classified as having toxicity. Otherwise patient will be classified as not having toxicity.
次要结局
- Tumour response(One year)
- Effect in brochopulmonary (COPD) disease.(One year)
- Incidence of acute and late toxicities(One year)
- Overall survival(One year)
- Disease-free survival(One year)
- Feasibility(One year)