Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

Study Overview
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Brief Summary
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This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.

Detailed Description
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Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P < 0.001) for non-small cell lung cancer ≤ 2 cm (CTR > 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.

Official Title
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Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study

Conditions
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Lung Neoplasms, Surgery

Intervention / Treatment
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* Procedure: Segmentectomy
* Procedure: Lobectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18-75 years old; 6 mm ≤ tumor size ≤ 20 mm; 0.25 < CTR < 1; Center of tumor located in the middle third of the lung field; ECOG score of 0,1 or 2; Lung function (FEV1 ≥ 1 L and ≥ 70%); Both lung segmentectomy and lobectomy could achieve R0 resection; No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy; No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis; Single tumor nodule or the concomitant nodule < microinvasive tumor; Written informed consent. Exclusion Criteria: The tumor nodule is located in right middle lobe; A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer); Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on; A serious mental illness; Pregnant and lactating women; Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months; With the history of cerebral infarction or cerebral hemorrhage within 6 months; With the history of sustained systemic corticosteroid therapy within 1 month; The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA Other unsuitable situations;

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: Segmentectomy<br>Patients receive segmentectomy | Procedure: Segmentectomy<br>* Patients receive segmentectomy<br>|
| Active Comparator: Lobectomy<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 |
| --- | --- | --- |
| 5-year Disease-Free Survival | The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality | From date of the recruitment, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day Morbidity and mortality rates | The rates of complications and death related to treatment during perioperative period | From date of the recruitment, assessed up to 30 days | 
| Pulmonary function in the first year after surgery | The Forced expiratory volume in one second (FEV1) in liter | From date of the 3rd, 6th, and 12th month after surgery | 
| 3-year Disease-Free-Survival | The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality | From date of the recruitment, assessed up to 36 months | 
| 5-year overall Survival | The time interval from randomization to death caused by any reason | From date of the recruitment, assessed up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer, Segmentectomy, Lobectomy, the middle third of the lung field