Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 14
- 主要终点
- Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation
研究概览
简要总结
The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy.
Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation.
The primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation.
Several departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study.
The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.
详细描述
The secondary objectives are:
- Validation of the Lent-Soma toxicity scale by comparison to the RTOG scale,
- Response rate at different times: week 6-8, 1 year and 2 years after the end of irradiation,
- Progression-free survival rate at 1 year and 2 years after the end of irradiation
- Confirmation of the predictive value of serum cytokine levels (IL-6 and IL-10) during irradiation for the occurrence of early radiation toxicity, and analysis of the correlation between these serum levels at inclusion and the expression polymorphism of candidate genes.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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-metastatic cytologically or histologically proven non-small-cell lung cancer (NSCLC)
- •Operated NSCLC patients requiring post-surgical irradiation or non-operated NSCLC patients requiring curative irradiation
- •Conformational thoracic radiotherapy with curative intent
- •Age >= 18
- •Complete functional respiratory evaluation (FRE) performed less than 2 months before inclusion, demonstrating a maximum expiratory flow-volume/second > 1 l (in case surgery, the FRE must have been realized in the post-surgery period)
- •Thoracic CT-scan performed less than 2 months before inclusion for non-operated patient
- •PET-scan performed less than 2 months before inclusion for non-operated patient
- •Performance status (PS) ECOG <= 1
- •Possible training on breath holding technique
- •Female patients of childbearing potential: effective method of contraception necessary
- •Mandatory affiliation with a social security system
- •Written, signed, informed consent
排除标准
- •Small-cell lung cancer
- •Metastatic disease
- •Infiltrating pulmonary disease
- •Previous thoracic irradiation
- •Indication of irradiation with palliative intent
- •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
- •Patient understanding incompatible with the breath-hold technique (patients with major presbycusis are not eligible)
- •Pregnant or lactating woman
- •Patient included in another clinical trial
- •Follow-up difficult
- •Patient deprived of freedom
结局指标
主要结局
Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation
时间窗: 6-8 and 10-12 weeks after the end of irradiation
次要结局
- RTOG and LENT-SOMA scores at 6-8 weeks and 10-12 weeks after the end of irradiation, response rates at 6-8 weeks, 1 year and 2 years after irradiation(6-8 and 10-12 weeks after the end of irradiation)