A Phase 3 interventional study of patients undergo cVATS segmentectomy and Patients undergo cVATS lobectomy in Non-small Cell Lung Cancer Stage I and Lung Adenocarcinoma, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Status unknown at 6 sites in China. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2013-12-16.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 3, Interventional, and Treatment
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.
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.
Patients will be followed up every 3 months within the first year, and annually for 5 years postoperatively.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 500 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Patients undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy
Procedure: patients undergo cVATS segmentectomy
Patients undergo cVATS lobectomy
Procedure: Patients undergo cVATS lobectomy
Relapse-free survival
Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy.
Time frame: From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years
5-year survival rate
Compare the 5-year survival rate of patients undergoing cVATS segmentectomy vs lobectomy
Time frame: participants are followed until death or up to 5 years
postoperative complication
Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy
Time frame: 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
Time frame: 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)
Time frame: 0 to 6 months postoperative
This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Guangzhou Medical University