ELobectomy for NSCLC by VATS Versus Thoracotomy (ECTOP-1007)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Lobectomy for Clincial Stage T1N0M0 Solid NSCLC by VATS Versus Thoracotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786003
• Other study ID #: LNVT
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: February 9, 2028

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: Haoxuan Wu, M.D.
• Phone: 86-13901770461
• Email: haoxuanwu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1086
• Est. completion date: February 9, 2028
• Est. primary completion date: February 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical stage T1N0M0 and surgical resectable.

• Solid appearance on computed tomography scan.

• Age 18 to 75 year.

• Signed the informed consent form.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Procedure:
• VATS
Standard video assisted thoracic surgery, no use of rib-spreader.
• Thoracotomy
Standard thoracotomy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Disease-free survival means the period after surgery when no disease can be detected.	3 years after the surgery
Secondary	Overall survival	Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause.	3 years after the surgery
Secondary	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.	1 month after surgery
Secondary	Pain degree and quality of life	Numerical rating score (NRS)	1 years after the surgery