Lung NeoplasmsNCT04631770
Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC
A study testing Systemic mediastinal lymph node dissection and Spared mediastinal lymph node dissection in people with Lung Neoplasms and Lymph Node Excision, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Neoplasms, Lymph Node Excision
- What is being tested?
- Systemic mediastinal lymph node dissection and Spared mediastinal lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,362 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ethics review board of Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Chenguang Li, +86-22-23340123, chengdongyan916@163.com
Zhenfa Zhang, MD
About this study
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
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.
Read the 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.
- Conditions
- Lung Neoplasms, Lymph Node Excision
- Being tested
- Systemic mediastinal lymph node dissection, Spared mediastinal lymph node dissection
- Keywords
- Non-small cell lung cancer, Mediastinal lymph node dissection, Ground-glass nodules
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic mediastinal lymph node dissectionProcedure or surgery
Systematic hilar and mediastinal lymph node dissection.
Spared mediastinal lymph node dissectionProcedure or surgery
Mediastinal lymph node is spared in this group.
| Study group | Role | What they receive |
|---|---|---|
| Mediastinal lymph node dissection group | Experimental | A Receives: Procedure: Systemic mediastinal lymph node dissection |
| Spared mediastinal lymph node dissection group | Active comparator | B Receives: Procedure: Spared mediastinal lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (6)
Relapse-free survival
RFS time is defined as days from randomization to relapse or death for any patient.
Measured: 5 years
Proportion of local recurrence
Proportion of local recurrence in any kind of recurrences.
Measured: 5 years
Duration of hospitalization
Duration of hospitalization around surgery.
Measured: 1-60 days
Duration of chest drainage tube placement
Duration of chest drainage tube placement after surgery.
Measured: 1-60 days
Operation time
Time duration of surgery.
Measured: 20-180 minutes.
Blood loss
Blood loss during surgery.
Measured: 1-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 May 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenfa Zhenfa, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631770
- Sponsor's protocol ID
- E2020306
- Status last verified
- May 2023
- First submitted
- 15 Nov 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available after publication of the study.
Publications
Li C, Ni Y, Liu C, Liu R, Zhang C, Song Z, Liu H, Jiang T, Zhang Z. 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, randomised, multicentre trial (MELDSIG) in China. BMJ Open. 2023 Oct 28;13(10):e075242. doi: 10.1136/bmjopen-2023-075242.
PubMed 37898488
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04631770
- Acronym / sponsor ID
- E2020306
- Conditions
- Lung Neoplasms, Lymph Node Excision
- Keywords
- Non-small cell lung cancer, Mediastinal lymph node dissection, Ground-glass nodules
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,362 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediastinal lymph node dissection group | Experimental | Procedure: Systemic mediastinal lymph node dissectionA |
| Spared mediastinal lymph node dissection group | Active comparator | Procedure: Spared mediastinal lymph node dissectionB |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic mediastinal lymph node dissectionSystematic hilar and mediastinal lymph node dissection. | Procedure or surgery | Mediastinal lymph node dissection group |
| Spared mediastinal lymph node dissectionMediastinal lymph node is spared in this group. | Procedure or surgery | Spared mediastinal lymph node dissection group |
Primary outcome
Overall survival
Time frame: 5 years
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.
6 secondary outcomes
Relapse-free survival
Time frame: 5 years
Proportion of local recurrence
Time frame: 5 years
Duration of hospitalization
Time frame: 1-60 days
Duration of chest drainage tube placement
Time frame: 1-60 days
Operation time
Time frame: 20-180 minutes.
Blood loss
Time frame: 1-60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 37898488Li C, Ni Y, Liu C, Liu R, Zhang C, Song Z, Liu H, Jiang T, Zhang Z. 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, randomised, multicentre trial (MELDSIG) in China. BMJ Open. 2023 Oct 28;13(10):e075242. doi: 10.1136/bmjopen-2023-075242.
- Individual participant dataSharing planned: Yes. Individual participant data will be available after publication of the study.
Related trials for Lung Neoplasms
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhenfa Zhenfa, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic mediastinal lymph node dissection and Spared mediastinal lymph node dissection in people with Lung Neoplasms and Lymph Node Excision, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenfa Zhang, MD (+862223340123, zhangzhenfa1973@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04631770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.