Status and phase
Conditions
Treatments
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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.
Primary purpose
Allocation
Interventional model
Masking
500 participants in 2 patient groups
Loading...
Central trial contact
Jianxing He, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal