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

NCT02011997 | Unknown Phase 3 DMC

• 1 other identifier: FAH-GZU-001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 6

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.

Conditions

Non-small Cell Lung Cancer Stage I; Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 5-year survival rate

  participants are followed until death or up to 5 years

• postoperative complication

  0 to 3 months postoperatively

• pulmonary function

  6 months after surgery

• Quality of Life

  0 to 6 months postoperative

Study Arms (2)

segmentectomy

EXPERIMENTAL

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

Procedure: patients undergo cVATS segmentectomy

Lobectomy

ACTIVE COMPARATOR

Patients undergo cVATS lobectomy

Procedure: Patients undergo cVATS lobectomy

Interventions

patients undergo cVATS segmentectomy PROCEDURE

segmentectomy

Patients undergo cVATS lobectomy PROCEDURE

Lobectomy

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (6)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

Nanfang Hospital

Guangzhou, Guangdong, China

Location

First Affiliated Hospital Zhejiang University colleague of Medicine

Hangzhou, Zhejiang, China

Location

China-Japan Friendship hospital

Beijing, China

Location

Peking University Cancer Hospital

Beijing, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

Related Publications (4)

• 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.

  PMID: 21828029 BACKGROUND

• 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.

  PMID: 7677489 BACKGROUND

• 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.

  PMID: 19766789 BACKGROUND

• 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.

  PMID: 19289625 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jianxing He, MD

  First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxing He, MD

CONTACT

83062810; drjianxinghe@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 16, 2013
• First Posted: December 16, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

CN (6)