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

Lung Adenocarcinoma Clinical Trial

— cVATS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02011997
• Other study ID #: FAH-GZU-001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 16, 2013
• Last updated: December 13, 2013
• Start date: December 2013
• Est. completion date: December 2021

Study information

• Verified date: December 2013
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Jianxing He, MD
• Phone: 83062810
• Email: drjianxinghe[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Adenocarcinoma
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage I

Intervention

Procedure:
• patients undergo cVATS segmentectomy

• Patients undergo cVATS lobectomy

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing
China	China-Japan Friendship hospital	Bejing
China	Nanfang Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	First Affiliated Hospital Zhejiang University colleague of Medicine	Hangzhou	Zhejiang
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	postoperative complication	Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy	0 to 3 months postoperatively	Yes
Secondary	pulmonary function	to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively	6 months after surgery	No
Secondary	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	No