A Single-Center, Prospective Phase II Clinical Study of Proton Beam Intensity-Modulated Stereotactic Radiotherapy for Early-Stage Non-Small Cell Lung Cancer
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Guangzhou Concord Cancer Center
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Progression-free Survival
概览
简要总结
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (AJCC eighth edition staging) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical proton hypofractionated radiotherapy. The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. After treatment, follow-up visits will be conducted to observe short-term and long-term efficacy, adverse reactions and patient quality of life.
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
- •.Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can also be included: diagnosed by more than 2 imaging modalities, and the clinical diagnosis of lung cancer is confirmed after MDT discussion.
- •The clinical staging based on PET-CT examination is: cT1\~3 N0M0, stage IA-IIB (AJCC eighth edition).
- •Age: 18 years and above.
- •KPS score ≥
- •The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
- •Relatively good organ function:
- •Normal bone marrow function: WBC≥3×109/L, Platelet ≥80×109/L, HGB≥90g/L
- •Normal liver and kidney function:
- •Total bilirubin, AST, and ALT≤2.0×upper limit of normal values;
- •Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
排除标准
- •Patients with other malignant tumors.
- •Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
- •Those whose laboratory test values do not meet relevant standards before enrollment.
- •Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- •Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
- •Patients considered inappropriate for inclusion by other investigators.
研究组 & 干预措施
Stereotactic Body Proton Therapy
The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.
干预措施: Stereotactic Body Proton Therapy (Radiation)
结局指标
主要结局
Progression-free Survival
时间窗: Up to 3 years
Progression Free Survival is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method
次要结局
- Overall Survival(UP to 3 years)
- Local Control Rate(Up to 3 years)
- Quality of life scores(Up to 3 years)
- Rate of grade 3-5 adverse events(Up to 3 years)