ChemoRadiotherapy with Or Without surgery followed by consolidation Durvalumab (CROWD): a phase IV feasibility trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Safety defined as the rates of severe surgical morbidity and mortality (Clavien-Dindo grade 3-5) and the percentage of patients with treatment-related adverse events (Gr III-V) within 90-days of surgery
研究概览
简要总结
-to assess the safety of surgery in patients with initially unresectable stage III NSCLC who are considered resectable by the multidisciplinary team within 12 weeks after finishing high-dose CRT -to assess the ability to proceed to durvalumab consolidation therapy after surgery
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage III (non-N3) NSCLC (TNM 8th edition), before start of chemoradiotherapy
- •In case of suspected N2-disease, mediastinal invasive staging (EUS, EBUS and/or mediastinoscopy) to prove N2 involvement before start of concurrent CRT is mandatory.
- •Initial MDT recommendation for a non-surgical treatment comprising CRT followed by durvalumab
排除标准
- •Patients with TxN3 or M1 disease
- •The use of any CRT schemes other than those in ESMO recommendations (platinum doublet, 30 once-daily fractions of 2 Gy)
- •Patients deemed inoperable based on cardiopulmonary function tests or comorbidity
- •Patients with known actionable genomic alterations.
结局指标
主要结局
Safety defined as the rates of severe surgical morbidity and mortality (Clavien-Dindo grade 3-5) and the percentage of patients with treatment-related adverse events (Gr III-V) within 90-days of surgery
Safety defined as the rates of severe surgical morbidity and mortality (Clavien-Dindo grade 3-5) and the percentage of patients with treatment-related adverse events (Gr III-V) within 90-days of surgery
Number of patients able to proceed to durvalumab consolidation after surgery
Number of patients able to proceed to durvalumab consolidation after surgery
次要结局
- Rate of complete surgical resection (R0)
- DFS in 2 years, defined from the day of surgery
研究者
Chris Dickhoff
Scientific
Amsterdam UMC Stichting