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

Guangzhou Medical University

Status and phase: Unknown; Phase 3

Conditions: Non-small Cell Lung Cancer Stage I; Lung Adenocarcinoma

Treatments: Procedure: Patients undergo cVATS lobectomy; Procedure: patients undergo cVATS segmentectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02011997

FAH-GZU-001

Details and patient eligibility

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.

• 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

segmentectomy

Experimental group

Description:

Patients undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy

Treatment:

Procedure: patients undergo cVATS segmentectomy

Lobectomy

Active Comparator group

Description:

Patients undergo cVATS lobectomy

Treatment:

Procedure: Patients undergo cVATS lobectomy