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

Phase 3UnknownNCT02011997

The First Affiliated Hospital of Guangzhou Medical University500 enrolled

Overview

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. * 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Non-small Cell Lung Cancer Stage I Lung Adenocarcinoma

Interventions

patients undergo cVATS segmentectomyPROCEDURE

Patients undergo cVATS lobectomyPROCEDURE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (6)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

First Affiliated Hospital Zhejiang University colleague of Medicine

Hangzhou, Zhejiang, China

China-Japan Friendship hospital

Beijing, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Jianxing He, MD

CONTACT

83062810 drjianxinghe@163.com

Data from ClinicalTrials.gov

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