Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Complete ablation rate at 6 months after ablation
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
详细描述
This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.
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
- 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 greater than 18 years.
- •Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
- •The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
- •Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.
排除标准
- •Patients with platelet < 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
- •Patients with severe pulmonary fibrosis and pulmonary hypertension.
- •Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever > 38.5℃.
- •Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
- •Patients with poorly controlled malignant pleural effusion.
- •Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5~7 days before ablation.
- •Eastern Cooperative Oncology Group (ECOG) score >
- •Combined with other tumors with extensive metastasis, expected survival < 6 months.
- •Patients with episodic psychosis.
- •Patients with implantable electronic devices (such as pacemaker or defibrillator).
- •Pregnant women, or patients who have pregnancy plans during the study.
- •Participation or ongoing participation in another clinical study within the past 30 days.
- •Other situations that the investigator deems inappropriate to participate in this study.
结局指标
主要结局
Complete ablation rate at 6 months after ablation
时间窗: 6 months
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.
次要结局
- Overall survival (OS)(3 years)
- Complete ablation rate 12 months after ablation(12 months)
- Progression free survival (PFS)(3 years)
- Technical success rate(Immediately after ablation)
- Safety(12 months)
- Local control rate at 1 year, 2 years and 3 years after ablation(1 year, 2 years and 3years)