NCT06730295招募中2 期
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer: a Prospective, Single-arm, Phase II Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年12月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incidence of grade 3 or higher SBRT-related toxicity
研究概览
简要总结
This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with centrally located early-stage 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
- •Histologically confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0), or recurrent disease (rT1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery.
- •Centrally located lung cancer.
- •Age 18 years or older, regardless of gender.
- •ECOG performance status score of 0-
- •Serum hemoglobin ≥ 80 g/L, platelets ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL.
- •Serum creatinine ≤ 1.25 times the upper normal limit (UNL) or creatinine clearance ≥ 60 ml/min.
- •Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.
- •FEV1 ≥ 0.5 L.
- •Normal CB6 range.
- •The patient and their family agree and sign the informed consent form.
排除标准
- •Any other disease or condition that contraindicates radiotherapy (e.g., active infections, within 6 months post-myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmias).
- •Pregnant or breastfeeding women, women who have not undergone pregnancy testing, and pregnant individuals.
- •Individuals with substance abuse issues, chronic alcoholism, or AIDS.
- •Individuals with uncontrollable seizures or loss of self-control due to psychiatric disorders.
- •Individuals with a history of severe allergies or specific sensitivities.
结局指标
主要结局
Incidence of grade 3 or higher SBRT-related toxicity
时间窗: 1-year
Incidence of grade 3 or higher SBRT-related toxicity
次要结局
- Objective response rate(2 months after radiotherapy])
- Local control rate(2-year)
- Progression-free survival(2-year)
研究者
Hui Liu
Pro.
Sun Yat-sen University
研究点 (1)
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