Comparison of cVATS Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion

Phase 3

• Conditions: Lung Adenocarcinoma; Non-small Cell Lung Cancer Stage I
• Interventions: Procedure: patients undergo cVATS segmentectomy; Procedure: Patients undergo cVATS lobectomy

• Registration Number: NCT02011997
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study First Submitted: 2013-11-16
• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-13
• Last Update Submitted: 2013-12-13
• Study First Posted: 2013-12-16
• Last Update Posted: 2013-12-16
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
segmentectomy	patients undergo cVATS segmentectomy	Patients undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy
Lobectomy	Patients undergo cVATS lobectomy	Patients undergo cVATS lobectomy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (6)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Peking University Cancer Hospital; 🇨🇳 Beijing, China

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

First Affiliated Hospital Zhejiang University colleague of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

China-Japan Friendship hospital; 🇨🇳 Bejing, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, China