Pneumonitis After Radiotherapy for Lung Cancer: A Symptom-Based Scoring System to Identify Patients Developing Radiation Pneumonitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Number of Participants With Grade ≥2 Radiation Pneumonitis
研究概览
简要总结
Major goals of radiotherapy include local disease control and improvement of the patients' prognoses. One possible side effect of radiotherapy for lung cancer is radiation pneumonitis. Severe (grade ≥3) radiation pneumonitis can even be fatal in approximately 2% of the patients. It would be important to identify patients developing radiation pneumonitis and requiring medical treatment early.
In the present study, the patients are asked to complete a questionnaire (paper version) once a week during the period of radiotherapy and up to 24 weeks following radiotherapy. In this questionnaire, the patients are asked to state and rate their symptoms potentially associated with pneumonitis. Scoring points are assigned to the severity of the symptoms (symptom scores), and the resulting sum score (patient score) will be used for identification of radiation pneumonitis.
The main goal of this trial is to evaluate the usefulness of a new symptom-based scoring system with respect to the identification of patients developing pneumonitis after radiotherapy of breast or lung cancer. The discriminative power of the symptom-based scoring system will be assessed by calculating the area under the ROC curve (AUC). Taking into account that 5% of patients will not qualify for Full Analysis Set, a total of 78 patients should be recruited.
If statistical significance of the AUC is reached, the most-informative (optimal) scoring point to identify radiation pneumonitis will be derived. Sensitivity analyses will be conducted to further investigate the performance of the symptom-based scoring system.
In 10 patients, the paper version of the symptom-based scoring system (questionnaire) will be supplemented by a mobile application (app) asking the same questions regarding symptoms potentially associated with radiation pneumonitis.
详细描述
Background Most patients with small-cell lung cancer (SCLC) receive radiotherapy in combination with chemotherapy as definitive treatment. Also, a considerable number of patients with advanced non-small-cell lung cancer (NSCLC) are treated with radiotherapy with or without concurrent chemotherapy. Radiation pneumonitis is a possible side effect of radiotherapy for lung cancer. Severe pneumonitis was reported to be fatal in approximately 2% of patients. In our centre, the prevalence of symptomatic radiation pneumonitis was 7.6% in patients irradiated for lung cancer. The prevalence of symptomatic radiation pneumonitis in patients with risk factors was 18.8%.
Pneumonitis can occur up to 23 weeks following radiotherapy. Therefore, the symptoms may not be associated with previous radiotherapy, and pneumonitis may be missed. It would be important to identify patients developing radiation pneumonitis and requiring medical treatment more early.
This study aims to develop a symptom-based scoring system that contributes to an earlier detection of radiation pneumonitis requiring medical intervention (grade ≥2) after radiotherapy for lung cancer. This scoring system is a prerequisite for a mobile application, which can be used by the patients at home to rate their symptoms possibly related to pneumonitis.
Patients are asked to complete a questionnaire (paper version) once a week during the period of radiotherapy and up to 24 weeks following radiotherapy. In this questionnaire, the patients are asked to state and rate their symptoms potentially associated with pneumonitis. Scoring points are assigned to the severity of the symptoms (symptom scores), and the resulting sum score (patient score) will be used for identification of radiation pneumonitis.
Primary endpoint To assess the performance characteristics of the symptom-based scoring system for detection of radiation pneumonitis the receiver operating characteristic (ROC) curve is used to show the connection between sensitivity and specificity for every possible cut-off for the scoring system and to select the optimal scoring point for detection of radiation pneumonitis- The area under the ROC curve (AUC) is calculated to prove the diagnostic ability of the scoring system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven lung cancer
- •Indication for radiotherapy
- •Risk factors for developing radiation pneumonitis
- •Age ≥18 years
- •Written informed consent
- •Capacity of the patient to contract
排除标准
- •Pregnancy, Lactation
- •Expected non-compliance
结局指标
主要结局
Number of Participants With Grade ≥2 Radiation Pneumonitis
时间窗: 24 weeks following radiotherapy
Radiation pneumonitis will been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
次要结局
未报告次要终点
研究者
Prof Dirk Rades
Professor and Chair
University Hospital Schleswig-Holstein