Lung Adenocarcinoma, Non-small Cell Lung Cancer Stage I
Conditions
Brief summary
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.
Detailed 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. * Arm I: Patients undergo cVATS lobectomy. * Arm II: Patients undergo cVATS segmentectomy. Patients will be followed up every 3 months within the first year, and annually for 5 years postoperatively.
Interventions
PROCEDUREpatients undergo cVATS segmentectomy
PROCEDUREPatients undergo cVATS lobectomy
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free survival | From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years | Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year survival rate | participants are followed until death or up to 5 years | Compare the 5-year survival rate of patients undergoing cVATS segmentectomy vs lobectomy |
| postoperative complication | 0 to 3 months postoperatively | Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy |
| pulmonary function | 6 months after surgery | to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively |
| Quality of Life | 0 to 6 months postoperative | 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) |
Countries
China
Contacts
Primary ContactJianxing He, MD
Outcome results
None listed