Non-small Cell Lung CancerNCT01102517

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

A study testing video-assisted thoracoscopic surgery and axillary thoracotomy in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial 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: 1. To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy. 2. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: video-assisted thoracoscopic surgery and axillary thoracotomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 1 siteChina
Study dates: Jan 2010to Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060

Other trials in China

About this study

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.

Conditions: Non-small Cell Lung Cancer
Being tested: video-assisted thoracoscopic surgery, axillary thoracotomy
Keywords: NSCLC, Clinical, Early-stage
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

video-assisted thoracoscopic surgeryProcedure or surgery
video-assisted thoracoscopic surgery
axillary thoracotomyProcedure or surgery
axillary thoracotomy lobectomy

Study groups in NCT01102517
Study group	Role	What they receive
VATS group	Experimental	video-assisted thoracoscopic surgery Receives: Procedure: video-assisted thoracoscopic surgery
axillary thoracotomy	Other	Control group Receives: Procedure: axillary thoracotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease-free survival and overall survival
Measured: 5 years

Secondary outcomes (6)

Quality of life
Lung Cancer Symptom Scale
Measured: the first year after the surgery
Postoperative pulmonary function
Measured: the first three months after the surgery
Postoperative Karnofsky performance status
Measured: the first year after the surgery
Postoperative Chest Pain
visual analogue scale and Wong-Baker FACES Pain Rating Scale
Measured: the first year after the surgery
Perioperation data
operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio
Measured: perioperation
Cytokines response
IL-2,IL-4,IL-6,IL-10,TNF,IFN-r
Measured: the first 48 hours after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Dec 2018

First posted13 Apr 2010 (estimated)
Study startJan 2010
Primary completionDec 2018 (estimated)
Study completionDec 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01102517
Sponsor's protocol ID: 2007039
Status last verified: Feb 2018
First submitted: 6 Apr 2010
Last updated: 28 Feb 2018
Results posted: No
Data monitoring committee: Yes

Publications

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.
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.
PubMed 29198623

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT01102517
Acronym / sponsor ID: 2007039
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC, Clinical, Early-stage
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 500 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
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
Study start: Jan 2010
Primary completion: Dec 2018 (estimated)
Study completion: Dec 2018 (estimated)
First posted: 13 Apr 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
VATS group	Experimental	Procedure: video-assisted thoracoscopic surgeryvideo-assisted thoracoscopic surgery
axillary thoracotomy	Other	Procedure: axillary thoracotomyControl group

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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 ;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
video-assisted thoracoscopic surgeryvideo-assisted thoracoscopic surgery	Procedure or surgery	VATS group
axillary thoracotomyaxillary thoracotomy lobectomy	Procedure or surgery	axillary thoracotomy

Primary outcome

Disease-free survival and overall survival
Time frame: 5 years

6 secondary outcomes

Quality of life
Time frame: the first year after the surgery
Postoperative pulmonary function
Time frame: the first three months after the surgery
Postoperative Karnofsky performance status
Time frame: the first year after the surgery
Postoperative Chest Pain
Time frame: the first year after the surgery
Perioperation data
Time frame: perioperation
Cytokines response
Time frame: the first 48 hours after the surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
Background1.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.
Derived from this study: PubMed 29198623Long 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.

Related trials for Non-small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hao Long, professor principal investigator

Sun Yat-Sen University Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing video-assisted thoracoscopic surgery and axillary thoracotomy in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival and overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01102517, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.