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.
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. Control group: Radiofrequency ablation was performed immediately after enrollment, and a placebo treatment program was given for 6 months after 1 week after radiofrequency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
260
Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency.
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China
overall survival rate,OS
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.
Time frame: 2 years
DFS
The time interval from the first medication to the observation of recurrence or metastasis, or death from any cause (calculated based on the previous event). Patients who have not relapsed, metastasized or died at the time of the data cutoff, and those who were lost to follow-up in the study will be counted on the date of their last tumor evaluation.
Time frame: 2 years
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