Comparison of cVATS Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion
NCT ID: NCT02011997
Last Updated: 2013-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
500 participants
INTERVENTIONAL
2013-12-31
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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segmentectomy
Patients undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy
patients undergo cVATS segmentectomy
Lobectomy
Patients undergo cVATS lobectomy
Patients undergo cVATS lobectomy
Interventions
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patients undergo cVATS segmentectomy
Patients undergo cVATS lobectomy
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
79 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Jianxing He
President
Principal Investigators
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Jianxing He, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Guangzhou Medical University
Locations
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
First Affiliated Hospital Zhejiang University colleague of Medicine
Hangzhou, Zhejiang, China
China-Japan Friendship hospital
Beijing, , China
Peking University Cancer Hospital
Beijing, , China
Shanghai Chest Hospital
Shanghai, , China
Countries
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Central Contacts
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References
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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.
Other Identifiers
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FAH-GZU-001
Identifier Type: -
Identifier Source: org_study_id