Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- HFPV vs free breathing: 1/3 decrease of V20 (lung) or 1/2 decrease of Dmax (breast)
研究概览
简要总结
That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment in patients with tumors that are moving with respiration like breast or lung cancers. The use of a High Frequency Percussive Ventilation system leads to the cessation of respiratory motions while administering radiotherapy (RT) to tumors which allows a reduction of the amount of irradiated normal tissues and which potentially decrease radiation-induced collateral damages.
详细描述
Primary objective :
Demonstrate the clinical benefit of the HFPV coupled to thoracic radiotherapy in 2 distinct and frequent clinical situations :
- Tomotherapy for lung and left breast tumors. The investigators assume that the volume of irradiated healthy tissue will be much less when using HFPV as compared to free breathing during tomotherapy sessions .
- In comparison with Active Breathing Control (ABC system). The investigators assume that the HFPV will lead to breathing motions cessation the same way as the ABC system, but will abrogate pause times when administrating the radiotherapy. This will shorten the radiotherapy sessions for lung patients treated with stereotaxis and for breast cancer patients.
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
- •breast cancer eligible for tomotherapy or linear accelerator with ABC system
- •lung cancer eligible for curative tomotherapy and with a significant breathing movements amplitude
- •lung cancer eligible for ablative stereotaxis
- •WHO 0 or 1
排除标准
- •patients requiring oxygen or not able to lie on the back (dyspnea)
- •pulmonary functions altered
- •cardiac insufficiency
- •patient not able to breathe with the High Frequency Ventilation System
- •risk of pneumothorax when experiencing High Frequency Ventilation
结局指标
主要结局
HFPV vs free breathing: 1/3 decrease of V20 (lung) or 1/2 decrease of Dmax (breast)
时间窗: 0-14 days between registration and treatment start according to standard patient care
Radiotherapy treatment fractions (locally advanced lung: 33 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start. Dose distribution will be determined for both situations and patients will be treated with the most favourable one.
HFPV vs ABC: decrease the duration of radiotherapy fractions (lung: 1/2 and breast 1/3)
时间窗: 0-14 days between registration and treatment start according to standard patient care
Lung (5 fractions) or breast (25 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start. The time of fractions administration will be compared to theoretical times of treatment when patient is free breathing (lung 45 min for 12Gy/ breast 10 min for 2Gy).
次要结局
未报告次要终点
研究者
Jean Bourhis
Head of radio-oncology
Centre Hospitalier Universitaire Vaudois