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

Last updated: December 13, 2013
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Adenocarcinoma

Lung Cancer

Bronchiolo-alveolar Carcinoma (Bac)

Treatment

N/A

Clinical Study ID

NCT02011997
FAH-GZU-001
  • Ages 20-79
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Preoperative criteria: peripheral non-small cell lung cancer, no larger than 2 cm inmaximal diameter, no lymph node metastasis, FEV1%>50% (FEV1: Forced Expiratory Volume in 1second); Preoperative imaging:pure ground-glass or mixed ground-glass nodules (part-solid, solidareas < 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 ofclinical surgical indications; Intraoperative criteria: histologically confirmed NSCLC, adenocarcinoma in situ or withmicroinvasion; No prior ipsilateral thoracotomy; No prior anti-neoplastic therapy; EOCG Performance status 0-2; Sufficient organ functions; Written informed consent.

Exclusion

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 obstructivepulmonary disease); Abnormal Psychosis; Uncontrollable diabetes mellitus; History of severe cardiovascular disease; Any condition which, in the opinion of the investigator might interfere with the evaluationof the objective.

Study Design

Total Participants: 500
Study Start date:
December 01, 2013
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Nanfang Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • First Affiliated Hospital Zhejiang University colleague of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Peking University Cancer Hospital

    Beijing,
    China

    Site Not Available

  • China-Japan Friendship hospital

    Bejing,
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai,
    China

    Site Not Available

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