A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
video-assisted thoracoscopic surgery
axillary thoracotomy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, Clinical, Early-stage
Eligibility 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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
VATS group
axillary thoracotomy
Arm Description
video-assisted thoracoscopic surgery
Control group
Outcomes
Primary Outcome Measures
Disease-free survival and overall survival
Secondary Outcome Measures
Quality of life
Lung Cancer Symptom Scale
Postoperative pulmonary function
Postoperative Karnofsky performance status
Postoperative Chest Pain
visual analogue scale and Wong-Baker FACES Pain Rating Scale
Perioperation data
operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio
Cytokines response
IL-2,IL-4,IL-6,IL-10,TNF,IFN-r
Full Information
NCT ID
NCT01102517
First Posted
April 6, 2010
Last Updated
February 27, 2018
Sponsor
Sun Yat-sen University
Collaborators
Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01102517
Brief Title
A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Shenzhen People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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:
To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy.
To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy.
To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer.
To explore the indication of VATS lobectomy for the lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC, Clinical, Early-stage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VATS group
Arm Type
Experimental
Arm Description
video-assisted thoracoscopic surgery
Arm Title
axillary thoracotomy
Arm Type
Other
Arm Description
Control group
Intervention Type
Procedure
Intervention Name(s)
video-assisted thoracoscopic surgery
Intervention Description
video-assisted thoracoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
axillary thoracotomy
Intervention Description
axillary thoracotomy lobectomy
Primary Outcome Measure Information:
Title
Disease-free survival and overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Quality of life
Description
Lung Cancer Symptom Scale
Time Frame
the first year after the surgery
Title
Postoperative pulmonary function
Time Frame
the first three months after the surgery
Title
Postoperative Karnofsky performance status
Time Frame
the first year after the surgery
Title
Postoperative Chest Pain
Description
visual analogue scale and Wong-Baker FACES Pain Rating Scale
Time Frame
the first year after the surgery
Title
Perioperation data
Description
operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio
Time Frame
perioperation
Title
Cytokines response
Description
IL-2,IL-4,IL-6,IL-10,TNF,IFN-r
Time Frame
the first 48 hours after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Long, professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
Citation
1.Bethencourt DM, Holmes EC. Muscle-sparing posterolateral thoracotomy. Ann Thorac Surg. 1988;45(3):337-339. 2.Ginsberg RJ. Alternative (muscle-sparing) incisions in thoracic surgery. Ann Thorac Surg. 1993;56(3):752-754. 3.Weissberg D, Kaufman M. Technical aids in surgery. Two muscle-sparing thoracotomies--techniques and indications. S Afr J Surg. 1990;28(1):17-19. 4.Akçali Y, Demir H, Tezcan B. The effect of standard posterolateral versus muscle-sparing thoracotomy on multiple parameters. Ann Thorac Surg. 2003;76(4):1050-1054. 5.Hazelrigg SR, Landreneau RJ, Boley TM, et al. The effect of muscle-sparing versus standard posterolateral thoracotomy on pulmonary function, muscle strength, and postoperative pain. J Thorac Cardiovasc Surg. 1991;101(3):394-400. 6.Kutlu CA, Akin H, Olcmen A, et al. Shoulder-girdle strength after standard and lateral muscle-sparing thoracotomy. Thorac Cardiovasc Surg. 2001;49(2):112-114. 7.Khan IH, McManus KG, McCraith A, et al. Muscle sparing thoracotomy: a biomechanical analysis confirms preservation of muscle strength but no improvement in wound discomfort. Eur J Cardiothorac Surg. 2000;18(6):656-661. 8.Baeza OR, Foster ED. Vertical axillary thoracotomy: a functional and cosmetically appealing incision. Ann Thorac Surg. 1976;22(3):287-288.
Results Reference
background
PubMed Identifier
29198623
Citation
Long H, Tan Q, Luo Q, Wang Z, Jiang G, Situ D, Lin Y, Su X, Liu Q, Rong T. Thoracoscopic Surgery Versus Thoracotomy for Lung Cancer: Short-Term Outcomes of a Randomized Trial. Ann Thorac Surg. 2018 Feb;105(2):386-392. doi: 10.1016/j.athoracsur.2017.08.045. Epub 2017 Dec 2.
Results Reference
derived
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A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer
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