Back to resultsMediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC
Primary Purpose
Lung Neoplasms, Lymph Node Excision
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Systemic mediastinal lymph node dissection
Spared mediastinal lymph node dissection
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms focused on measuring Non-small cell lung cancer, Mediastinal lymph node dissection, Ground-glass nodules
Eligibility Criteria
Inclusion Criteria:
- No history of malignancies or lung surgery; Diagnosed as NSCLC prior or in lung surgery; Chest CT shows GGNs with C/T ≤ 0.25; Peripheral clinical stage T1N0M0 lung cancer; No anti-cancer treatment prior to surgery.
Exclusion Criteria:
- Non clinical stage T1N0M0 lung cancer; Unable to have complete resection of lung cancer; Chest CT shows GGNs with C/T > 0.25; History of malignancies; Had any anti-cancer treatment prior to surgery.
Sites / Locations
- Ethics review board of Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mediastinal lymph node dissection group
Spared mediastinal lymph node dissection group
Arm Description
A
B
Outcomes
Primary Outcome Measures
Overall survival
Overall survival is defined as days from randomization to death from any cause, and it was censored at the last day when the patient was alive.
Secondary Outcome Measures
Relapse-free survival
RFS time is defined as days from randomization to relapse or death for any patient.
Proportion of local recurrence
Proportion of local recurrence in any kind of recurrences.
Duration of hospitalization
Duration of hospitalization around surgery.
Duration of chest drainage tube placement
Duration of chest drainage tube placement after surgery.
Operation time
Time duration of surgery.
Blood loss
Blood loss during surgery.
Full Information
NCT ID
NCT04631770
First Posted
November 15, 2020
Last Updated
September 24, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04631770
Brief Title
Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC
Official Title
Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage IA Non-small Cell Lung Cancer Presented as Ground-glass Nodules: Study Protocol of a Phase III, Randomized, Multi-center Trial (MELDSIG) in China
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Lung cancer is the leading cause of cancer related death worldwide. Lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. About 50% lung nodules are pure ground-glass or part-solid nodules. Non-solid nodules rarely develop mediastinal lymph node metastasis. The present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule CT features.
Detailed Description
The study is a non-inferior statistical comparison, with 681 patients in each group. The anticipated enroll period is 3 years, followed by observation period of 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Lymph Node Excision
Keywords
Non-small cell lung cancer, Mediastinal lymph node dissection, Ground-glass nodules
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1362 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mediastinal lymph node dissection group
Arm Type
Experimental
Arm Description
A
Arm Title
Spared mediastinal lymph node dissection group
Arm Type
Active Comparator
Arm Description
B
Intervention Type
Procedure
Intervention Name(s)
Systemic mediastinal lymph node dissection
Intervention Description
Systematic hilar and mediastinal lymph node dissection.
Intervention Type
Procedure
Intervention Name(s)
Spared mediastinal lymph node dissection
Intervention Description
Mediastinal lymph node is spared in this group.
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is defined as days from randomization to death from any cause, and it was censored at the last day when the patient was alive.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Relapse-free survival
Description
RFS time is defined as days from randomization to relapse or death for any patient.
Time Frame
5 years
Title
Proportion of local recurrence
Description
Proportion of local recurrence in any kind of recurrences.
Time Frame
5 years
Title
Duration of hospitalization
Description
Duration of hospitalization around surgery.
Time Frame
1-60 days
Title
Duration of chest drainage tube placement
Description
Duration of chest drainage tube placement after surgery.
Time Frame
1-60 days
Title
Operation time
Description
Time duration of surgery.
Time Frame
20-180 minutes.
Title
Blood loss
Description
Blood loss during surgery.
Time Frame
1-60 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Thin-slice HRCT shows single GGN with C/T ≤ 0.5 and no lymph node metastasis;
Clinical stage IA NSCLC (TNM 8th classification) diagnosed prior or in surgery;
No history of malignancies within past 5 years or lung surgery;
No anti-cancer treatment prior to surgery.
Exclusion Criteria:
Simultaneous or metachronous (within the past 5 years) double cancers;
Active bacterial or fungous infection;
Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema;
Systemic steroidal medication;
Uncontrollable diabetes mellitus; (vi) Uncontrollable hypertension or history of severe heart disease, heart failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenfa Zhang, MD
Phone
+862223340123
Email
zhangzhenfa1973@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chenguang Li, MD
Phone
+862218622819082
Email
cgli82@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenfa Zhenfa, MD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ethics review board of Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenguang Li
Phone
+86-22-23340123
Email
chengdongyan916@163.com
First Name & Middle Initial & Last Name & Degree
Zhenfa Zhang, MD
First Name & Middle Initial & Last Name & Degree
Chenguang Li, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be available after publication of the study.
IPD Sharing Time Frame
After the follow-up period of the study.
Learn more about this trial
Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC
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