Comparison of cVATS Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion (cVATS)
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|ClinicalTrials.gov Identifier: NCT02011997|
Recruitment Status : Not yet recruiting
First Posted : December 16, 2013
Last Update Posted : December 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Stage I Lung Adenocarcinoma||Procedure: patients undergo cVATS segmentectomy Procedure: Patients undergo cVATS lobectomy||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Video-assisted Thoracoscopic Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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
- Relapse-free survival [ Time Frame: From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years ]Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy.
- 5-year survival rate [ Time Frame: participants are followed until death or up to 5 years ]Compare the 5-year survival rate of patients undergoing cVATS segmentectomy vs lobectomy
- postoperative complication [ Time Frame: 0 to 3 months postoperatively ]Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy
- pulmonary function [ Time Frame: 6 months after surgery ]to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively
- Quality of Life [ Time Frame: 0 to 6 months postoperative ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011997
|Contact: Jianxing He, MDfirstname.lastname@example.org|
|The First Affiliated Hospital of Guangzhou Medical University|
|Guangzhou, Guangdong, China, 510000|
|Guangzhou, Guangdong, China|
|First Affiliated Hospital Zhejiang University colleague of Medicine|
|Hangzhou, Zhejiang, China|
|Peking University Cancer Hospital|
|China-Japan Friendship hospital|
|Shanghai Chest Hospital|
|Principal Investigator:||Jianxing He, MD||First Affiliated Hospital of Guangzhou Medical University|