Comparison of cVATS Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion

Study Overview
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Brief Summary
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This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.

Detailed Description
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Lobectomy has long been considered the standard procedure for early-stage lung cancer, and minimally invasive techniques have been demonstrated to be associated with superior outcomes compared with lobectomy by thoracotomy. the us of segmentectomy is under investigation for selected patients with small tumors, and the use of minimally invasive strategies is applicable as well. This nationwide, multicenter, prospective, randomized open phase III study of cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy versus Lobectomy for stage IA non-small cell lung cancer (NSCLC) patients with Lung adenocarcinoma in situ or with microinvasion, is aiming to evaluate the relapse free survival and 5 year overall survival (OS) rate of two types of surgery. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo cVATS lobectomy. Arm II: Patients undergo cVATS segmentectomy. Patients will be followed up every 3 months within the first year, and annually for 5 years postoperatively.

Official Title
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Comparison of Video-assisted Thoracoscopic Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion

Conditions
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Non-small Cell Lung Cancer Stage I, Lung Adenocarcinoma

Intervention / Treatment
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* Procedure: patients undergo cVATS segmentectomy
* Procedure: Patients undergo cVATS lobectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preoperative criteria: peripheral non-small cell lung cancer, no larger than 2 cm in maximal diameter, no lymph node metastasis, FEV1%>50% (FEV1: Forced Expiratory Volume in 1 second); Preoperative imaging:pure ground-glass or mixed ground-glass nodules (part-solid, solid areas < 0.5cm); Follow-up duration last 3 months or more, HRCT (HRCT: high-resolution computed tomography) lesion maximum diameter was measured three times and took the average, meet the criteria of clinical surgical indications; Intraoperative criteria: histologically confirmed NSCLC, adenocarcinoma in situ or with microinvasion; No prior ipsilateral thoracotomy; No prior anti-neoplastic therapy; EOCG Performance status 0-2; Sufficient organ functions; Written informed consent. Exclusion Criteria: Active bacterial or fungous infection; Simultaneous or prior (within the past 5 years) other malignant disease; Interstitial pneumonitis, pulmonary fibrosis, or severe COPD (COPD: chronic obstructive pulmonary disease); Abnormal Psychosis; Uncontrollable diabetes mellitus; History of severe cardiovascular disease; Any condition which, in the opinion of the investigator might interfere with the evaluation of the objective.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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 undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy | Procedure: patients undergo cVATS segmentectomy<br> <br> |
| Active Comparator: Lobectomy<br>Patients undergo cVATS lobectomy | Procedure: Patients undergo cVATS lobectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival | Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy. | From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year survival rate | Compare the 5-year survival rate of patients undergoing cVATS segmentectomy vs lobectomy | participants are followed until death or up to 5 years | 
| postoperative complication | Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy | 0 to 3 months postoperatively | 
| pulmonary function | to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively | 6 months after surgery | 
| Quality of Life | To evaluate the quality of life (QoL) of these patients, as measured by questionnaire of FACT-L (4th edition) and LCSS (Lung Cancer Symptom Scale) | 0 to 6 months postoperative |