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NCT Number: NCT04631770

Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC

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.

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Key information

Conditions

Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lymph Node Excision Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ethics review board of Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systemic mediastinal lymph node dissection

Procedure

Systematic hilar and mediastinal lymph node dissection.

Spared mediastinal lymph node dissection

Procedure

Mediastinal lymph node is spared in this group.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Relapse-free survival

    Time frame: 5 years

    RFS time is defined as days from randomization to relapse or death for any patient.

  2. Proportion of local recurrence

    Time frame: 5 years

    Proportion of local recurrence in any kind of recurrences.

  3. Duration of hospitalization

    Time frame: 1-60 days

    Duration of hospitalization around surgery.

  4. Duration of chest drainage tube placement

    Time frame: 1-60 days

    Duration of chest drainage tube placement after surgery.

  5. Operation time

    Time frame: 20-180 minutes.

    Time duration of surgery.

  6. Blood loss

    Time frame: 1-60 days

    Blood loss during surgery.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Nov 17, 2020
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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