Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer

Study Overview
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Brief Summary
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The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. The aim of this study is to investigate whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or not.

Official Title
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A Multi-center, Randomized-controlled, Open-label Clinical Trial: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Procedure: sublobar resection
* Procedure: lobectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cT1N0M0 non-small-cell lung cancer ground-glass opacity, ≤2cm, GGO≥25% eligible for both lobectomy and sublobar resection intraoperative pathology is minimally-invasive adenocarcinoma or invasive adenocarcinoma intraoperative pathology of biopsied station 10 lymph node is negative Exclusion Criteria: intraoperative pathology is benign nodule, atypical adenomatous hyperplasia, or adenocarcinoma in-situ intraoperative pathology of biopsied station 10 lymph node is positive multiple GGOs, lesions other than dominant lesion are malignant or >5mm history of thoracic surgery history of malignancy in recent 5 years unstable systemic disease patients with psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublobar group<br>Patients receive sublobar resection, including wedge resection and segmentectomy. | Procedure: sublobar resection<br>* Patients receive sublobar resection, which includes wedge resection and segmentectomy.<br>|
| Active Comparator: Lobectomy group<br>Patients receive lobectomy. | Procedure: lobectomy<br>* patients receive lobectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | survival status of patients after surgery | five years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival | recurrence status of patients after surgery | five years after surgery | 
| Local and distant recurrence rates | recurrence rate of local and distant locations respectively | five years after surgery | 
| Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter | FEV1 of patients after surgery | 3rd, 6th, 12th, and 24th month after surgery | 
| Pulmonary Function: forced vital capacity (FVC) in liter | FVC of patients after surgery | 3rd, 6th, 12th, and 24th month after surgery | 
| Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg | DLCO of patients after surgery | 3rd, 6th, 12th, and 24th month after surgery | 
| Morbidity rate | the rates of complications related to treatment during perioperative period | up to 30 days after surgery | 
| Mortality rate | the rates of death related to treatment during perioperative period | up to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sublobar resection, lobectomy