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

Primary Purpose

Non-small Cell Lung Cancer Stage I, Lung Adenocarcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
patients undergo cVATS segmentectomy
Patients undergo cVATS lobectomy
Sponsored by
The First Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer Stage I

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University
  • Nanfang Hospital
  • First Affiliated Hospital Zhejiang University colleague of Medicine
  • Peking University Cancer Hospital
  • China-Japan Friendship hospital
  • Shanghai Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

segmentectomy

Lobectomy

Arm Description

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

Patients undergo cVATS lobectomy

Outcomes

Primary Outcome Measures

Relapse-free survival
Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy.

Secondary Outcome Measures

5-year survival rate
Compare the 5-year survival rate of patients undergoing cVATS segmentectomy vs lobectomy
postoperative complication
Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy
pulmonary function
to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively
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)

Full Information

First Posted
November 16, 2013
Last Updated
December 13, 2013
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02011997
Brief Title
Comparison of cVATS Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion
Acronym
cVATS
Official Title
Comparison of Video-assisted Thoracoscopic Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Stage I, Lung Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
segmentectomy
Arm Type
Experimental
Arm Description
Patients undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy
Arm Title
Lobectomy
Arm Type
Active Comparator
Arm Description
Patients undergo cVATS lobectomy
Intervention Type
Procedure
Intervention Name(s)
patients undergo cVATS segmentectomy
Intervention Type
Procedure
Intervention Name(s)
Patients undergo cVATS lobectomy
Primary Outcome Measure Information:
Title
Relapse-free survival
Description
Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy.
Time Frame
From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years
Secondary Outcome Measure Information:
Title
5-year survival rate
Description
Compare the 5-year survival rate of patients undergoing cVATS segmentectomy vs lobectomy
Time Frame
participants are followed until death or up to 5 years
Title
postoperative complication
Description
Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy
Time Frame
0 to 3 months postoperatively
Title
pulmonary function
Description
to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively
Time Frame
6 months after surgery
Title
Quality of Life
Description
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)
Time Frame
0 to 6 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxing He, MD
Phone
83062810
Email
drjianxinghe@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianxing He, MD
Organizational Affiliation
First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
First Affiliated Hospital Zhejiang University colleague of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Peking University Cancer Hospital
City
Beijing
Country
China
Facility Name
China-Japan Friendship hospital
City
Bejing
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21828029
Citation
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.
Results Reference
background
PubMed Identifier
7677489
Citation
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.
Results Reference
background
PubMed Identifier
19766789
Citation
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.
Results Reference
background
PubMed Identifier
19289625
Citation
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.
Results Reference
background

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

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