Improving Standard of Care Lifestyle Support for Stage III NSCLC Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Compliance
研究概览
简要总结
Offering an early-initiated supportive care program to stage III NSCLC patients to prevent deterioration of performance status and increase compliance of patients that complete chemoradiation as well as the patients receiving 12 months of durvalumab.
详细描述
In inoperable Stage III Non-Small Cell Lung Cancer (NSCLC), consolidation immune checkpoint inhibition with the PD-L1 inhibitor durvalumab, given within 6 weeks after completion of concurrent platinum-based chemoradiotherapy (CCRT) for 12 months results in remarkable improvement of 3-year overall survival rates (57% vs 43.5%). This tri-modal therapy has become the new standard of care. Unfortunately, the tri-modal therapy frequently causes adverse events such as fatigue and, to a much lesser degree, cough, dyspnea and pneumonitis, resulting in treatment cessation in 15% - 53% of the patients (15%) (53%). For the most optimal overall survival (OS) and disease-free survival (DFS), compliance to the full treatment regimen, i.e. in the ideal situation 100% of patients completing their full course of CCRT and receiving durvalumab for one year, is expected to have significant and relevant beneficial effects. Optimizing patients' fitness is essential in order to handle the tough full treatment regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Pathological diagnosis of adequately staged (according to standard practice using chest-CT, FDG-PET, brain imaging MRI/CT) NSCLC
- •Participant is willing and able to give informed consent for participation in the trial
- •Aged 18 years or above
- •Scheduled to receive one of the following two therapeutic strategies:
- •Concurrent chemotherapy and radiotherapy with photons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC
- •Concurrent chemotherapy and radiotherapy with protons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC
- •Able and willing to comply with all trial requirements
排除标准
- •Mixed non-small cell lung cancer with other histology such as small cell lung cancer
- •Not able to comply with the study protocol
- •Less than 18 years old
- •Pregnancy or not able to comply with adequate contraception in women with child baring potential
- •Previous radiotherapy to the chest for benign or malignant conditions, including radiation for breast cancer
- •Previous malignancy treated with chemotherapy, immune therapy or radiotherapy (irrespective of when this happened)
- •Previous malignancies treated with surgery only are allowed if 2 years or more before inclusion in the present study
结局指标
主要结局
Compliance
时间窗: 12 months
Compliance to CCRT and durvalumab treatment
次要结局
- Perctenage use of watch(12 months)
- Standard of care lifestyle support(12 months)
- Percentage adhering advice(12 months)
- Percentage dysphagia(12 months)
- Percentage dyspnea(12 months)
- Barriers(12 months)
- Proton/photon(12 months)
- Percentage hospitalization(12 months)
- Durvalumab(12 months)
- Quality of life questionnaire(12 months)