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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2029-05-01

Brief Summary

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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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Detailed Description

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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

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Lung Neoplasms Lymph Node Excision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mediastinal lymph node dissection group

A

Group Type EXPERIMENTAL

Systemic mediastinal lymph node dissection

Intervention Type PROCEDURE

Systematic hilar and mediastinal lymph node dissection.

Spared mediastinal lymph node dissection group

B

Group Type ACTIVE_COMPARATOR

Spared mediastinal lymph node dissection

Intervention Type PROCEDURE

Mediastinal lymph node is spared in this group.

Interventions

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Systemic mediastinal lymph node dissection

Systematic hilar and mediastinal lymph node dissection.

Intervention Type PROCEDURE

Spared mediastinal lymph node dissection

Mediastinal lymph node is spared in this group.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No