NCT07164885招募中不适用
Phase II/III Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive RadioTherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients
Capital Medical University1 个研究点 分布在 1 个国家目标入组 911 人开始时间: 2025年2月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 911
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This is a Phase II/III randomized clinical trial of Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology (RAPART) in locally advanced non-small cell lung cancer patients. The main objective is to test the overall improvement of overall survival (OS), progression free survival (PFS), and local progression free survival (LPFS) of unresectable stage III NSCLC under standard and non-standard mixed treatment conditions compared to conventional 60Gy radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adult research participants, aged over 18 years old;
- •Non small cell lung cancer that requires pathological confirmation;
- •All stage 3 unresectable non-small cell lung cancer, including stage correction after MDT and stage downgrading after treatment (4 → 3), and stage upregulation due to disease progression (2 → 3);
- •ECOG physical condition is 0-2;
- •In addition to study participants who have not received any treatment, study participants who have undergone surgery, chemotherapy, immunotherapy, and targeted therapy are also eligible for enrollment.
排除标准
- •Prisoners who are not convenient for close clinical follow-up;
- •Study participants with contraindications to radiation therapy.
结局指标
主要结局
overall survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
次要结局
- progression-free survival(From enrollment to 3 years after the end of treatment)
- Toxic events(From enrollment to 3 years after treatment)
研究者
Jin jianyue
Professor
Capital Medical University
研究点 (1)
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