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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Adenocarcinoma; Non-small Cell Lung Cancer Stage I
• Intervention / Treatment: Procedure: patients undergo cVATS segmentectomy; Procedure: Patients undergo cVATS lobectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jianxing He, MD; Phone Number: 83062810; Email: drjianxinghe@163.com

Study Locations

• China
  • Beijing, China
    • Peking University Cancer Hospital
  • Bejing, China
    • China-Japan Friendship Hospital
  • Shanghai, China
    • Shanghai Chest Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital of Guangzhou Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • First Affiliated Hospital Zhejiang University colleague of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: segmentectomy; Patients undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy	Procedure: patients undergo cVATS segmentectomy
Active Comparator: Lobectomy; Patients undergo cVATS lobectomy	Procedure: Patients undergo cVATS lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse-free survival	Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy.	From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year survival rate	Compare the 5-year survival rate of patients undergoing cVATS segmentectomy vs lobectomy	participants are followed until death or up to 5 years
postoperative complication	Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy	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	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)	0 to 6 months postoperative

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Jianxing He, MD, First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

General Publications

• Van Schil PE, Asamura H, Rusch VW, Mitsudomi T, Tsuboi M, Brambilla E, Travis WD. Surgical implications of the new IASLC/ATS/ERS adenocarcinoma classification. Eur Respir J. 2012 Feb;39(2):478-86. doi: 10.1183/09031936.00027511. Epub 2011 Aug 4.
• Ginsberg RJ, Rubinstein LV. Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group. Ann Thorac Surg. 1995 Sep;60(3):615-22; discussion 622-3. doi: 10.1016/0003-4975(95)00537-u.
• Koike T, Togashi K, Shirato T, Sato S, Hirahara H, Sugawara M, Oguma F, Usuda H, Emura I. Limited resection for noninvasive bronchioloalveolar carcinoma diagnosed by intraoperative pathologic examination. Ann Thorac Surg. 2009 Oct;88(4):1106-11. doi: 10.1016/j.athoracsur.2009.06.051.
• Yan TD, Black D, Bannon PG, McCaughan BC. Systematic review and meta-analysis of randomized and nonrandomized trials on safety and efficacy of video-assisted thoracic surgery lobectomy for early-stage non-small-cell lung cancer. J Clin Oncol. 2009 May 20;27(15):2553-62. doi: 10.1200/JCO.2008.18.2733. Epub 2009 Mar 16.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 16, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2013
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma in Situ; Adenocarcinoma; Adenocarcinoma of Lung; Adenocarcinoma in Situ
• Other Study ID Numbers: FAH-GZU-001