Carcinoma, Non-Small-Cell LungNCT03786003
ELobectomy for NSCLC by VATS Versus Thoracotomy (ECTOP-1007)
A study testing VATS and Thoracotomy in people with Carcinoma, Non-Small-Cell Lung, run by Fudan University at 1 site in China.
Trial summary
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1007). The goal of this study is to determine video-assisted thoracoscopic surgery is non-inferior to thoracotomy in terms of disease-free survival for solid clinical stage T1N0M0 NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- VATS and Thoracotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,086 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2022to 9 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical stage T1N0M0 and surgical resectable.
- Solid appearance on computed tomography scan.
- Age 18 to 75 year.
- Signed the informed consent form.
Who cannot join
- Not NSCLC in pathological analysis.
- Not lobectomy or sublobar resection.
- History of other malignant tumors within 5 years.
- History of thoracic surgery or unsuitable for VATS.
- Previous radiation or chemotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Haiquan Chen, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Haoxuan Wu, Doctor, (86)13901770461, haoxuanwu@hotmail.com
About this study
Official title: Lobectomy for Clincial Stage T1N0M0 Solid NSCLC by VATS Versus Thoracotomy
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1007). The goal of this study is to determine video-assisted thoracoscopic surgery is non-inferior to thoracotomy in terms of disease-free survival for solid clinical stage T1N0M0 NSCLC.
Read the detailed description
It is a randomized clinical trial comparing video-assisted thoracoscopic surgery (VATS) with thoracotomy for solid clinical stage T1N0M0 NSCLC. The primary objective of the study is to determine that VATS is non-inferior to thoracotomy in terms of disease-free survival (DFS). Secondary objectives are to compare VATS and thoracotomy for overall survival (OS), perioperative complications, pain levels and quality of life.
Although there are numerous retrospective studies have indicated feasibility and effectiveness of VATS, no data has been reported from those prospective and randomized clinical trials with prognostic indicators as the primary objective. Whether VATS is non-inferior to thoracotomy in terms of survival is still unclear. Therefore, we design this trial by recruiting patients in clinical stage T1N0M0 with solid mass on computed tomography (CT). To determine the clinical stage, CT scans will be performed routinely and PET-CT/EBUS-TBNA/mediastinoscopy will be conducted in patients with suspected positive mediastinum lymph node or distant metastases. Detailed inclusion criteria include clinical stage T1N0M0 and surgical resectable, solid appearance on CT, age 18 to 75 year and signed informed consent. Exclusion criteria includes not NSCLC in pathologic analysis, no lobectomy or sublobar resection, history of other malignant tumors within 5 years, history of thoracic surgery or unsuitable for VATS and previous radiation or chemotherapy.
In our previous data, the 3-year DFS for cT1N0M0 patients with solid mass who were subjected to thoracotomy (lobectomy or sublobar resection) was 77.9%. If the 3-year DFS of VATS arm is not less than 70.9%, the VATS arm will be regarded to be non-inferior to thoracotomy. A sample size of at least 1086 participants is required for performance equal to 80%, α-level equal to 0.025, 1:1 recruitment and considering a dropout rate of 10%. Participants will be randomly assigned to either group using a random table.
Lobectomy or sublobar resection will be conducted by standard procedures at the discretion of the surgeon. Each participating surgeon will be evaluated by the trial committee to ensure proper surgical technique. If the VATS is diverted to thoracotomy intraoperartively, the reason will be recorded, and the cause will still be analyzed in an intention-to-treat analysis. Patients will be follow-up every 6 months to 3 years after surgery.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- VATS, Thoracotomy
- Keywords
- Video-Assisted Thoracic Surgery, Thoracotomy, Early-stage 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.
VATSProcedure or surgery
Standard video assisted thoracic surgery, no use of rib-spreader.
ThoracotomyProcedure or surgery
Standard thoracotomy
| Study group | Role | What they receive |
|---|---|---|
| VATS | Experimental | Video-assisted thoracoscopic surgery Receives: Procedure: VATS |
| Thoracotomy | Active comparator | Open surgery Receives: Procedure: Thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival means the period after surgery when no disease can be detected.
Measured: 3 years after the surgery
Secondary outcomes (3)
Overall survival
Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause.
Measured: 3 years after the surgery
Rate of patients with perioperative complication
The perioperative complication includes wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc within a month after surgery.
Measured: 1 month after surgery
Pain degree and quality of life
Numerical rating score (NRS)
Measured: 1 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start9 Feb 2022
- Primary completion9 Feb 2025 (estimated)
- Study completion9 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Fudan 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
- None (open label)
- Enrolment
- 1,086 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Shanghai Cancer Center Chen, Ph.D, Principal investigator, Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786003
- Sponsor's protocol ID
- LNVT
- Status last verified
- Jul 2023
- First submitted
- 19 Dec 2018
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Inform Consent Form, Clinical Study Report would be shared every 3 months after the study begin.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lobectomy for Clincial Stage T1N0M0 Solid NSCLC by VATS Versus Thoracotomy
- ClinicalTrials.gov ID
- NCT03786003
- Acronym / sponsor ID
- LNVT
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Video-Assisted Thoracic Surgery, Thoracotomy, Early-stage NSCLC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,086 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 9 Feb 2025 (estimated)
- Study completion
- 9 Feb 2028 (estimated)
- First posted
- 24 Dec 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.
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1007). The goal of this study is to determine video-assisted thoracoscopic surgery is non-inferior to thoracotomy in terms of disease-free survival for solid clinical stage T1N0M0 NSCLC.
Detailed description
It is a randomized clinical trial comparing video-assisted thoracoscopic surgery (VATS) with thoracotomy for solid clinical stage T1N0M0 NSCLC. The primary objective of the study is to determine that VATS is non-inferior to thoracotomy in terms of disease-free survival (DFS). Secondary objectives are to compare VATS and thoracotomy for overall survival (OS), perioperative complications, pain levels and quality of life.
Although there are numerous retrospective studies have indicated feasibility and effectiveness of VATS, no data has been reported from those prospective and randomized clinical trials with prognostic indicators as the primary objective. Whether VATS is non-inferior to thoracotomy in terms of survival is still unclear. Therefore, we design this trial by recruiting patients in clinical stage T1N0M0 with solid mass on computed tomography (CT). To determine the clinical stage, CT scans will be performed routinely and PET-CT/EBUS-TBNA/mediastinoscopy will be conducted in patients with suspected positive mediastinum lymph node or distant metastases. Detailed inclusion criteria include clinical stage T1N0M0 and surgical resectable, solid appearance on CT, age 18 to 75 year and signed informed consent. Exclusion criteria includes not NSCLC in pathologic analysis, no lobectomy or sublobar resection, history of other malignant tumors within 5 years, history of thoracic surgery or unsuitable for VATS and previous radiation or chemotherapy.
In our previous data, the 3-year DFS for cT1N0M0 patients with solid mass who were subjected to thoracotomy (lobectomy or sublobar resection) was 77.9%. If the 3-year DFS of VATS arm is not less than 70.9%, the VATS arm will be regarded to be non-inferior to thoracotomy. A sample size of at least 1086 participants is required for performance equal to 80%, α-level equal to 0.025, 1:1 recruitment and considering a dropout rate of 10%. Participants will be randomly assigned to either group using a random table.
Lobectomy or sublobar resection will be conducted by standard procedures at the discretion of the surgeon. Each participating surgeon will be evaluated by the trial committee to ensure proper surgical technique. If the VATS is diverted to thoracotomy intraoperartively, the reason will be recorded, and the cause will still be analyzed in an intention-to-treat analysis. Patients will be follow-up every 6 months to 3 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS | Experimental | Procedure: VATSVideo-assisted thoracoscopic surgery |
| Thoracotomy | Active comparator | Procedure: ThoracotomyOpen surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical stage T1N0M0 and surgical resectable.
- Solid appearance on computed tomography scan.
- Age 18 to 75 year.
- Signed the informed consent form.
Key exclusion criteria (5 listed)
- Not NSCLC in pathological analysis.
- Not lobectomy or sublobar resection.
- History of other malignant tumors within 5 years.
- History of thoracic surgery or unsuitable for VATS.
- Previous radiation or chemotherapy.
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 |
|---|---|---|
| VATSStandard video assisted thoracic surgery, no use of rib-spreader. | Procedure or surgery | VATS |
| ThoracotomyStandard thoracotomy | Procedure or surgery | Thoracotomy |
Primary outcome
Disease-free survival
Time frame: 3 years after the surgery
Disease-free survival means the period after surgery when no disease can be detected.
3 secondary outcomes
Overall survival
Time frame: 3 years after the surgery
Rate of patients with perioperative complication
Time frame: 1 month after surgery
Pain degree and quality of life
Time frame: 1 years after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: Yes. Study Protocol, Inform Consent Form, Clinical Study Report would be shared every 3 months after the study begin.
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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.
Haiquan Chen, Ph.D contact
Shanghai Cancer Center Chen, Ph.D principal investigator
Shanghai 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 VATS and Thoracotomy in people with Carcinoma, Non-Small-Cell Lung, run by Fudan 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 5 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: looking for participants now, as of the sponsor's last update on 21 Jul 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haoxuan Wu, M.D. (86-13901770461, haoxuanwu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 3 years after the surgery). 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 21 Jul 2023; AzTrials last refreshed its copy on 31 Oct 2026.