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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Procedure: VATS; Procedure: Thoracotomy

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 Type: Interventional
• Enrollment (Estimated): 1086
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haoxuan Wu, M.D.; Phone Number: 86-13901770461; Email: haoxuanwu@hotmail.com
• Study Contact Backup: Name: Haiquan Chen, Ph.D

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Haoxuan Wu, Doctor; Phone Number: (86)13901770461; Email: haoxuanwu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VATS; Video-assisted thoracoscopic surgery	Procedure: VATS; Standard video assisted thoracic surgery, no use of rib-spreader.
Active Comparator: Thoracotomy; Open surgery	Procedure: Thoracotomy; Standard thoracotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Disease-free survival means the period after surgery when no disease can be detected.	3 years after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Pain degree and quality of life	Numerical rating score (NRS)	1 years after the surgery

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Shanghai Cancer Center Chen, Ph.D, Shanghai Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Estimated): February 9, 2025
• Study Completion (Estimated): February 9, 2028

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Thoracotomy; Video-Assisted Thoracic Surgery; Early-stage NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LNVT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol, Inform Consent Form, Clinical Study Report would be shared every 3 months after the study begin.
• IPD Sharing Time Frame: Every 3 months after the study begin.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No