ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 321 for:    "Adenocarcinoma of lung"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02011997
Recruitment Status : Not yet recruiting
First Posted : December 16, 2013
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: segmentectomy
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. postoperative complication [ Time Frame: 0 to 3 months postoperatively ]
    Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy

  3. 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

  4. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


Contacts
Contact: Jianxing He, MD 83062810 drjianxinghe@163.com

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510000
Nanfang Hospital Not yet recruiting
Guangzhou, Guangdong, China
China, Zhejiang
First Affiliated Hospital Zhejiang University colleague of Medicine Not yet recruiting
Hangzhou, Zhejiang, China
China
Peking University Cancer Hospital Not yet recruiting
Beijing, China
China-Japan Friendship hospital Not yet recruiting
Bejing, China
Shanghai Chest Hospital Not yet recruiting
Shanghai, China
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
Principal Investigator: Jianxing He, MD First Affiliated Hospital of Guangzhou Medical University

Publications:
Responsible Party: Jianxing He, President, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02011997     History of Changes
Other Study ID Numbers: FAH-GZU-001
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Lung Neoplasms
Adenocarcinoma in Situ
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma in Situ