Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly and/or Frail Stage III Non-small-cell Lung Cancer Patients Unfit for Concurrent Chemoradiotherapy: an Open Label, Two Cohorts, Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at time of study entry
- •Histologically documented diagnosis of unresectable stage III NSCLC;
- •Fully-informed written consent obtained from patients;
- •Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1；
- •Adequate bone marrow, liver and kidney function
- •Life expectancy of at least 3 months
- •At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated
- •Histologic or cytologic confirmation of small cell lung cancer
- •Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
排除标准
- •Previous chemo-, immuno- or radiotherapy for NSCLC
- •Major surgical procedure last 28 days
- •History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
- •Uncontrolled intercurrent illness
- •Other active malignancy
- •Leptomeningeal carcinomatosis
- •Immunosuppressive medication
- •Pregnant or breastfeeding women
结局指标
主要结局
progression-free survival
时间窗: 12 months after last patient entry
time from treatment start until death or progression of tumor disease within one year
次要结局
- 5-year overall survival(5-years after last patient entry)
- 1-year overall survial(12 months after last patient entry)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year(12 months after last patient entry)