A Single-Center, Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Early-Stage 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
- 65
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer. The prescribed dose for patients with peripheral lung cancer is 48-60Gray(Gy) (Relative Biological Effectiveness, 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 multidisciplinary team (MDT) discussion.
- •The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1~3 N0M0, stage IA-IIB (AJCC eighth edition).
- •Age: 18 years and above.
- •Karnofsky(KPS) score ≥
- •The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
- •Relatively good organ function:
- •Normal bone marrow function: white blood cell (WBC)≥3×109/L, Platelet ≥80×109/L, Hemoglobin(HGB)≥90g/L
- •Normal liver and kidney function:
- •Total bilirubin, Aspartate Aminotransferase(AST), and ALT(Alanine Aminotransferase)≤2.0×upper limit of normal values;
- •Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
- •The patient has signed an informed consent form and is willing and able to comply with planned study visits, treatment plans, laboratory tests, and other study procedures.
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(PFS) 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)
- Quality of life scores(Up to 3 years)
- Rate of grade 3-5 adverse events(Up to 3 years)
- Local Control Rate(Up to 3 years)