This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments video-assisted thoracoscopic surgery, axillary thoracotomy
Phase phase 3
Sponsor Sun Yat-sen University
Collaborator Shanghai Chest Hospital
Start date January 2010
End date December 2016
Trial size 500 participants
Trial identifier NCT01102517, 2007039


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:

1. To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy.

2. To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy.

3. To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer.

4. To explore the indication of VATS lobectomy for the lung cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
video-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
Control group
axillary thoracotomy
axillary thoracotomy lobectomy

Primary Outcomes

Disease-free survival and overall survival
time frame: 5 years

Secondary Outcomes

Quality of life
time frame: the first year after the surgery
Postoperative pulmonary function
time frame: the first three months after the surgery
Postoperative Karnofsky performance status
time frame: the first year after the surgery
Postoperative Chest Pain
time frame: the first year after the surgery
Perioperation data
time frame: perioperation
Cytokines response
time frame: the first 48 hours after the surgery

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Principal investigator Hao Long, professor
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.