Non-small Cell Lung CancerNCT03613467
Is Video-assisted Thoracoscopic Lobectomy a Clinical Alternative for Surgically Resectable Pathologic N2 NSCLC Patients
An observational study of Non-small Cell Lung Cancer, run by Tang-Du Hospital at 10 sites in China.
Trial summary
The study was designed to compare the safety and effectiveness of vedio-assisted thoracoscopic lobectomy with open lobectomy for patients with surgically resectable pathologic N2 non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- VATS lobectomy and Thoracotomy lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,145 participants
- Where
- 10 sitesChina
- Study dates
- 4 Jul 2018to 6 Jul 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pathologically diagnosed N2 non-small cell lung cancer who received VATS or thoracotomy lobectomy between 2014 and 2017
Who may be able to join
- Patients with age > 18 years old;
- Patients with pathologically diagnosed non-small cell lung cancer;
- Patients underwent lobectomy by either VATS or thoracotomy between 2014 and 2017;
- Patients who received lymphadenectomy for all accessible lymph nodes;
- Patients with N2 lymph nodes (+) after surgeries;
Who cannot join
- Patients with second primary tumors or multiple primary tumors;
- Patients who received chest surgeries before hospitalization;
- Patients with superior pulmonary sulcus tumor
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
China PLA General Hospital
Beijing, Beijing Municipality, 100853
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, 610041
First Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, 310003
Jiangsu cancer hospital
Nanjing, Jiangsu, 210009
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, 430030
Xi'an Tangdu Hospital
Xi'an, Shaanxi, 710000
Henan Cancer Hospital
Zhengzhou, Henan, 450003
About this study
Official title: Vedio-assisted Thoracoscopic Lobectomy vs Open Lobectomy for Patients With Surgically Resectable Pathologic N2 NSCLC
The study was designed to compare the safety and effectiveness of vedio-assisted thoracoscopic lobectomy with open lobectomy for patients with surgically resectable pathologic N2 non-small cell lung cancer
Read the detailed description
The is a multi-center retrospective study. Patients with pathologic N2 NSCLC who underwent VATS or open lobectomy between 2014 and 2017 were included into this study. Clinical data on patient demographic, clinical characteristics, treatment and clinical outcomes will be collected to evaluate the safety and effectiveness of video-assisted thoracoscopic lobectomy for pathologic N2 NSCLC.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- VATS lobectomy, Thoracotomy lobectomy
- Keywords
- Vedio-assisted thoracoscopic lobectomy, Thoracotomy lobectomy, Real-world evidences;, pN2 NSCLC
- 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.
VATS lobectomyProcedure or surgery
Patients who received lobectomy by video-assisted thoracoscopic surgery
Thoracotomy lobectomyProcedure or surgery
Patients who received lobectomy by thoracotomy
| Study group | Role | What they receive |
|---|---|---|
| VATS lobectomy | Pathologic N2 NSCLC patients who received lobectomy by video-assisted thoracoscopic surgery Receives: Procedure: VATS lobectomy | |
| Thoracotomy lobectomy | Pathologic N2 NSCLC patients who received lobectomy by thoracotomy Receives: Procedure: Thoracotomy lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 2014-2018
Secondary outcomes (5)
Duration of hospital stay [Perioperative outcomes]
Duration of hospital stay [Perioperative outcomes]
Measured: 2014-2017
Postoperative 30 and 90 days [Perioperative outcomes]
Postoperative 30 and 90 days [Perioperative outcomes]
Measured: 2014-2017
Drainage time [Perioperative outcomes]
Drainage time [Perioperative outcomes]
Measured: 2014-2017
Intraoperative blood loss [Perioperative outcomes]
Intraoperative blood loss [Perioperative outcomes]
Measured: 2014-2017
Postoperative complications [Perioperative outcomes]
Postoperative complications [Perioperative outcomes]
Measured: 2014-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start4 Jul 2018
- Primary completion4 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, lixiaofei, Tang-Du Hospital
- Investigators
- Xiaofei Li, PhD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613467
- Sponsor's protocol ID
- W-TONG06
- Status last verified
- Aug 2018
- First submitted
- 16 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vedio-assisted Thoracoscopic Lobectomy vs Open Lobectomy for Patients With Surgically Resectable Pathologic N2 NSCLC
- ClinicalTrials.gov ID
- NCT03613467
- Acronym / sponsor ID
- W-TONG06
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Vedio-assisted thoracoscopic lobectomy, Thoracotomy lobectomy, Real-world evidences;, pN2 NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,145 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 3 Aug 2018 (actual)
- 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 study was designed to compare the safety and effectiveness of vedio-assisted thoracoscopic lobectomy with open lobectomy for patients with surgically resectable pathologic N2 non-small cell lung cancer
Detailed description
The is a multi-center retrospective study. Patients with pathologic N2 NSCLC who underwent VATS or open lobectomy between 2014 and 2017 were included into this study. Clinical data on patient demographic, clinical characteristics, treatment and clinical outcomes will be collected to evaluate the safety and effectiveness of video-assisted thoracoscopic lobectomy for pathologic N2 NSCLC.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS lobectomy | – | Procedure: VATS lobectomyPathologic N2 NSCLC patients who received lobectomy by video-assisted thoracoscopic surgery |
| Thoracotomy lobectomy | – | Procedure: Thoracotomy lobectomyPathologic N2 NSCLC patients who received lobectomy by thoracotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologically diagnosed N2 non-small cell lung cancer who received VATS or thoracotomy lobectomy between 2014 and 2017
Key inclusion criteria (5 listed)
- Patients with age > 18 years old;
- Patients with pathologically diagnosed non-small cell lung cancer;
- Patients underwent lobectomy by either VATS or thoracotomy between 2014 and 2017;
- Patients who received lymphadenectomy for all accessible lymph nodes;
- Patients with N2 lymph nodes (+) after surgeries;
Key exclusion criteria (3 listed)
- Patients with second primary tumors or multiple primary tumors;
- Patients who received chest surgeries before hospitalization;
- Patients with superior pulmonary sulcus tumor
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 |
|---|---|---|
| VATS lobectomyPatients who received lobectomy by video-assisted thoracoscopic surgery | Procedure or surgery | VATS lobectomy |
| Thoracotomy lobectomyPatients who received lobectomy by thoracotomy | Procedure or surgery | Thoracotomy lobectomy |
Primary outcome
Overall survival
Time frame: 2014-2018
Overall survival
5 secondary outcomes
Duration of hospital stay [Perioperative outcomes]
Time frame: 2014-2017
Postoperative 30 and 90 days [Perioperative outcomes]
Time frame: 2014-2017
Drainage time [Perioperative outcomes]
Time frame: 2014-2017
Intraoperative blood loss [Perioperative outcomes]
Time frame: 2014-2017
Postoperative complications [Perioperative outcomes]
Time frame: 2014-2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Xiaofei Li, PhD principal investigator
Tang-Du Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Tang-Du Hospital at 10 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: 2014-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2018.