A Prospective, Double-blind, Randomized Controlled Study of Radiofrequency Ablation Combined With Melatonin in the Treatment of Stage IA NSCLC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- overall survival rate，OS
研究概览
简要总结
Based on the recommendations of the guidelines, as well as the previous animal studies and clinical studies of our team, we designed and carried out prospective, randomized controlled, double-blind clinical studies to further expand the sample size to verify the efficacy of radiofrequency ablation combined with melatonin in the treatment of stage IA NSCLC. It is hoped that this combined treatment plan can delay the recurrence of lung cancer after RFA and prolong the survival time of patients.
详细描述
OBJECTIVES:
To verify the efficacy of radiofrequency ablation combined with melatonin in the treatment of stage IA non-small cell lung cancer, and explore new directions for the prevention and treatment of early stage non-small cell lung cancer.
OUTLINE:
This is a Prospective, double-blind, randomized controlled study. Using the same admission criteria, it is planned to enroll 260 patients, who will be randomly assigned 1:1. The experimental group: radiofrequency ablation combined with melatonin, and the control group: radiofrequency ablation combined with placebo.
Intervention group: Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) Patients can understand and voluntarily join this study, sign an informed consent form, and have good compliance.
- •(2) Patients with peripheral early lung cancer who cannot tolerate surgery with poor cardiopulmonary function; (3) Patients with peripheral early-stage lung cancer who cannot tolerate surgery; (4) Patients with peripheral early lung cancer who are unwilling to undergo surgery; (5) The tumor is more than 1.0 cm away from large blood vessels or larger bronchi.
- •(6) Age ≥18 years old and ≤85 years old; (7) ECOG PS score: 0-2 points; (8) Good coagulation function, platelet count ≥100×10^9/L, INR and PT≤1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the intended use range of anticoagulation drugs; (9) Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy test within 7 days before study entry Negative, and must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.
排除标准
- •(1) Those with severe comorbidities, infection period, and immunocompromised persons; (2) Patients who are judged to seriously affect survival or cannot tolerate thoracoscopic surgery in pre-assessment; (3) Patients who have contraindications to radiofrequency ablation and cannot complete the treatment; (4) Merge other organ/system tumors. (5) At present, patients with long-term oral hormones and autoimmune diseases (6) Various bleeding diseases, acute infectious diseases, fever, women during pregnancy, (7) Recovery period after heart surgery or stent implantation. (8) Those who are difficult to cooperate to complete the baseline test; those who cannot take drugs regularly;
结局指标
主要结局
overall survival rate，OS
时间窗: 2 years
From the beginning of randomization to the time of death due to any reason (patients who are lost to follow-up are the time of the last follow-up; patients who are still alive at the end of the study are the end of follow-up), when the survival curve reaches 2 years, the survival rate of patients.
次要结局
- DFS(2 years)
研究者
Ming Li
Associate senior doctor
Shanghai 10th People's Hospital