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

NCT03786003 | Recruiting DMC

• 1 other identifier: LNVT
• Study Type: interventional
• Target: 1,086
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Video-Assisted Thoracic Surgery; Thoracotomy; Early-stage NSCLC

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Disease-free survival means the period after surgery when no disease can be detected.

  3 years after the surgery

Secondary Outcomes (3)

• Overall survival

  3 years after the surgery

• Rate of patients with perioperative complication

  1 month after surgery

• Pain degree and quality of life

  1 years after the surgery

Study Arms (2)

VATS

EXPERIMENTAL

Video-assisted thoracoscopic surgery

Procedure: VATS

Thoracotomy

ACTIVE COMPARATOR

Open surgery

Procedure: Thoracotomy

Interventions

VATS PROCEDURE

Standard video assisted thoracic surgery, no use of rib-spreader.

VATS

Thoracotomy PROCEDURE

Standard thoracotomy

Thoracotomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical stage T1N0M0 and surgical resectable.
• Solid appearance on computed tomography scan.
• Age 18 to 75 year.
• Signed the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thoracic Surgery, Video-Assisted; Thoracotomy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Shanghai Cancer Center Chen, Ph.D

  Shanghai Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haoxuan Wu, M.D.

CONTACT

86-13901770461; haoxuanwu@hotmail.com

Haiquan Chen, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 24, 2018
• Study Start: February 9, 2022
• Primary Completion: February 9, 2025
• Study Completion (Estimated): February 9, 2028
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Every 3 months after the study begin.

Locations

CN (1)