A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Sun Yat-sen University
Sponsor:
Collaborators:
West China Hospital
The Tumour Hospital of Harbin Medical University
The Second Affiliated Hospital of Harbin Medical University
Peking University First Hospital
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Fudan University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Shenzhen People's Hospital
Information provided by (Responsible Party):
Hao Long, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01102517
First received: April 6, 2010
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to establish the effects of VATS lobectomy for early-stage non-small cell lung cancer.

The aims of this study are:

  1. To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy.
  2. To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy.
  3. To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer.
  4. To explore the indication of VATS lobectomy for the lung cancer.

Condition Intervention Phase
Non-small Cell Lung Cancer
Procedure: video-assisted thoracoscopic surgery
Procedure: axillary thoracotomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Disease-free survival and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: the first year after the surgery ] [ Designated as safety issue: Yes ]
    Lung Cancer Symptom Scale

  • Postoperative pulmonary function [ Time Frame: the first three months after the surgery ] [ Designated as safety issue: Yes ]
  • Postoperative Karnofsky performance status [ Time Frame: the first year after the surgery ] [ Designated as safety issue: Yes ]
  • Postoperative Chest Pain [ Time Frame: the first year after the surgery ] [ Designated as safety issue: Yes ]
    visual analogue scale and Wong-Baker FACES Pain Rating Scale

  • Perioperation data [ Time Frame: perioperation ] [ Designated as safety issue: Yes ]
    operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio

  • Cytokines response [ Time Frame: the first 48 hours after the surgery ] [ Designated as safety issue: Yes ]
    IL-2,IL-4,IL-6,IL-10,TNF,IFN-r


Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VATS group
video-assisted thoracoscopic surgery
Procedure: video-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
axillary thoracotomy
Control group
Procedure: axillary thoracotomy
axillary thoracotomy lobectomy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Early stage NSCLC and no metastasis of hilum of lung and mediastinum lymph nodes (short diameter ≤ 1 cm) on computed tomography (CT) scan;
  • No medical contraindications to lung resection
  • Age ≤ 75 years old and ≥18 years old;
  • Sign the informed consent form.

Exclusion Criteria:

  • Evidence of invasion into neighboring organs;
  • Extensive pleura adhesion;
  • Central lesion;
  • Not suitable for single-lung ventilation;
  • Had history of thoracotomy and radiation for thoracic region ;
  • Pregnancy or lactation female patients;
  • Cannot sign the informed consent form because of psychological, family and society factors;
  • Had history of other malignant tumors within 5 years except for non-melanoma cutaneous cancer, uterine cervix cancer in situ and curative early-stage carcinoma of prostate;
  • Participants can not accept operation for other uncontrolled factors.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102517

Contacts
Contact: Hao Long, Professor +86-20-87343317 longhao@sysucc.org.cn
Contact: Jun Zeng +86-20-87343736 zengjun@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
GuangZhou, Guangdong, China, 510060
Contact: Hao Long, professor    +86-20-87343314    longhao@sysucc.org.cn   
Contact: Jun Zeng    +86-20-87343736    zengjun@sysucc.org.cn   
Principal Investigator: Hao Long, professor         
Sponsors and Collaborators
Sun Yat-sen University
West China Hospital
The Tumour Hospital of Harbin Medical University
The Second Affiliated Hospital of Harbin Medical University
Peking University First Hospital
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Fudan University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Shenzhen People's Hospital
Investigators
Principal Investigator: Hao Long, professor Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Hao Long, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01102517     History of Changes
Other Study ID Numbers: 2007039
Study First Received: April 6, 2010
Last Updated: October 19, 2012
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
NSCLC
Clinical
Early-stage

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014