ELobectomy for NSCLC by VATS Versus Thoracotomy (ECTOP-1007)
NCT ID: NCT03786003
Last Updated: 2023-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1086 participants
INTERVENTIONAL
2022-02-09
2028-02-09
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VATS
Video-assisted thoracoscopic surgery
VATS
Standard video assisted thoracic surgery, no use of rib-spreader.
Thoracotomy
Open surgery
Thoracotomy
Standard thoracotomy
Interventions
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VATS
Standard video assisted thoracic surgery, no use of rib-spreader.
Thoracotomy
Standard thoracotomy
Eligibility Criteria
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Inclusion Criteria
* Solid appearance on computed tomography scan.
* Age 18 to 75 year.
* Signed the informed consent form.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Fudan University
OTHER
Responsible Party
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Haiquan Chen
Director
Principal Investigators
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Shanghai Cancer Center Chen, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Cancer Center
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Haiquan Chen, Ph.D
Role: CONTACT
Facility Contacts
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Other Identifiers
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LNVT
Identifier Type: -
Identifier Source: org_study_id
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