A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to establish the effects of VATS lobectomy for early-stage non-small cell lung cancer. The aims of this study are: To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy. To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy. To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer. To explore the indication of VATS lobectomy for the lung cancer.

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Procedure: video-assisted thoracoscopic surgery
* Procedure: axillary thoracotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Early stage NSCLC and no metastasis of hilum of lung and mediastinum lymph nodes (short diameter ≤ 1 cm) on computed tomography (CT) scan; No medical contraindications to lung resection Age ≤ 75 years old and ≥18 years old; Sign the informed consent form. Exclusion Criteria: Evidence of invasion into neighboring organs; Extensive pleura adhesion; Central lesion; Not suitable for single-lung ventilation; Had history of thoracotomy and radiation for thoracic region ; Pregnancy or lactation female patients; Cannot sign the informed consent form because of psychological, family and society factors; Had history of other malignant tumors within 5 years except for non-melanoma cutaneous cancer, uterine cervix cancer in situ and curative early-stage carcinoma of prostate; Participants can not accept operation for other uncontrolled factors.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VATS group<br>video-assisted thoracoscopic surgery | Procedure: video-assisted thoracoscopic surgery<br>* video-assisted thoracoscopic surgery<br>|
| Other: axillary thoracotomy<br>Control group | Procedure: axillary thoracotomy<br>* axillary thoracotomy lobectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival and overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Lung Cancer Symptom Scale | the first year after the surgery | 
| Postoperative pulmonary function |  | the first three months after the surgery | 
| Postoperative Karnofsky performance status |  | the first year after the surgery | 
| Postoperative Chest Pain | visual analogue scale and Wong-Baker FACES Pain Rating Scale | the first year after the surgery | 
| Perioperation data | operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio | perioperation | 
| Cytokines response | IL-2,IL-4,IL-6,IL-10,TNF,IFN-r | the first 48 hours after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Clinical, Early-stage