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Radiofrequency Ablation Combined With Melatonin in the Treatment of Stage IA NSCLC

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ClinicalTrials.gov Identifier: NCT04530097
Recruitment Status : Not yet recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ming Li, Shanghai 10th People's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
NSCLC and Theropy Procedure: RFA Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Double-blind, Randomized Controlled Study of Radiofrequency Ablation Combined With Melatonin in the Treatment of Stage IA NSCLC
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arms and Interventions
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Arm Intervention/treatment
Experimental: RFA+MLT
Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency.
 Procedure: RFA
Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency.
Other Name: MLT
No Intervention: RFA
Radiofrequency ablation was performed immediately after enrollment, and a placebo treatment program was given for 6 months after 1 week after radiofrequency.


Outcome Measures
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Primary Outcome Measures :
  1. overall survival rate，OS [ Time Frame: 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.


Secondary Outcome Measures :
  1. DFS [ Time Frame: 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • (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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530097


Locations
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China, Shanghai
Shanghai 10th People's Hospital
Shanghai, Shanghai, China, +86200072
Contact: Li Ming, M.D.    13391358760    mlid163@163.com   
Sponsors and Collaborators
Shanghai 10th People's Hospital
More Information
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Responsible Party: Ming Li, Associate senior doctor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT04530097    
Other Study ID Numbers: 2020KT128
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ming Li, Shanghai 10th People's Hospital:
NSCLC
radiofrequency ablation
Melatonin
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases