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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Current Primary Outcome: Relapse-free survival [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 5-year survival rate [ Time Frame: 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 [ Time Frame: 0 to 3 months postoperatively ]
    Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy
  • pulmonary function [ Time Frame: 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 [ Time Frame: 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)


Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Guangzhou Medical University

Dates:
Date Received: November 16, 2013
Date Started: December 2013
Date Completion: December 2021
Last Updated: December 13, 2013
Last Verified: December 2013