NCT02011997

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

Comparison of Video-assisted Thoracoscopic Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer Stage I
• Lung Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	patients undergo cVATS segmentectomy
PROCEDURE	Patients undergo cVATS lobectomy

Timeline

• Start date: 2013-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2013-12-16
• Last updated: 2013-12-16

Locations

6 sites across 1 country: China