A Single-arm Phase I/II Clinical Study of Simultaneous Integrated Boost Accelerated Hyperfractionated Radiotherapy for High-proliferation Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of Late Treatment-Related Toxicity
研究概览
简要总结
This is a prospective, single-arm, single-center phase I/II clinical trial evaluating the safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of simultaneous integrated boost accelerated hyperfractionated radiotherapy in patients with high-proliferation non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years, male or female;
- •Histologically or cytologically confirmed high-proliferation non-small cell lung cancer (NSCLC);
- •Assessed by a multidisciplinary team (MDT) and planned to receive thoracic radiotherapy (either curative or palliative), regardless of stage.
排除标准
- •Small cell histology;
- •Severe cardiac disease (New York Heart Association [NYHA] functional class ≥ III, uncontrolled arrhythmia, or myocardial infarction within the past 6 months);
- •Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use effective contraceptive measures;
- •Concurrent participation in other interventional clinical trials;
- •Other conditions deemed by the investigator to make the patient unsuitable for enrollment (e.g., severe mental illness).
研究组 & 干预措施
hyperfractionated radiotherapy
simultaneous integrated boost accelerated hyperfractionated radiotherapy
干预措施: hyperfractionated radiotherapy (Radiation)
结局指标
主要结局
Incidence of Late Treatment-Related Toxicity
时间窗: From more than 90 days after completion of radiotherapy through 2 years after completion of radiotherapy.
The incidence and severity of late treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Incidence of Acute Treatment-Related Toxicity
时间窗: From the start of radiotherapy through 90 days after completion of radiotherapy.
The incidence and severity of acute treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
次要结局
- Objective Response Rate (ORR)(Every 3 months after completion of radiotherapy, up to 2 years.)
- Progression-Free Survival (PFS)(From enrollment until documented disease progression or death from any cause, up to 2 years.)
- Overall Survival (OS)(From enrollment until death from any cause, up to 2 years.)