A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer | NCT01102517 | Trialant
Unknown statusInterventionalNot ApplicableUpdated Feb 28, 2018
A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer
ClinicalTrials.gov ID
NCT01102517
Lead Sponsor
Sun Yat-sen UniversityOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Not Applicable
Enrollment
500Actual
Last Update Posted
Feb 28, 2018Actual
Start Date
Jan 2010
Primary Completion Date
Dec 2018Estimated
Completion Date
Dec 2018Estimated
Brief Summary
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.
Non-small Cell Lung Cancer
video-assisted thoracoscopic surgery
axillary thoracotomy
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
No central contacts
There are no central contacts for this study.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060, China
Lead Sponsor
Sun Yat-sen UniversityOTHER
Collaborators
Shanghai Chest HospitalOTHER
Shanghai Pulmonary Hospital, Shanghai, ChinaOTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityOTHER