VATS VS. Open Thoracic Surgery for Stage II - III Lung Cancer

NCT04009915 | Unknown Phase 3

• 1 other identifier: Duanliang 1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with stage I lung cancer, the NCCN guidelines point out that if the patient has no contraindications for anatomy and surgery, as long as it does not violate the standard of tumor treatment and the principle of thoracic surgery, it is highly recommended of VATS or minimally invasive surgery. Although previous papers seem to have obvious advantages, there is a lack of clinical prospective data from patients with stage II-III lung cancer, and especially in the prevalence of uniportal VATS, there is still no objective analysis of this hypothesis. Therefore, the investigators plan to conduct a randomized, prospective study to compare perioperative complications, postoperative pain, life quality, lung function recovery, tumor-free survival rate, etc., in lobectomy for stage II-III lung cancer patients with VATS and thoracotomy.

Conditions

Lung Cancer; Surgery

Outcome Measures

Primary Outcomes (1)

• disease free survival after surgery

  Determine if VATS provides a non inferior oncologic control to open Lobectomy, as measure by 3-year progression free survival.

  3 years

Secondary Outcomes (2)

• Postoperative pain

  6 month

• Quality of life

  6 month

Study Arms (2)

VATS

EXPERIMENTAL

Patients undergo a standard VATS operation for stage II-III lung cancer

Procedure: VATS

open surgery

ACTIVE COMPARATOR

Patients undergo a standard open operation for stage II-III lung cancer

Procedure: Open surgery

Interventions

VATS PROCEDURE

Patients undergo a standard VATS operation for stage II-III lung cancer called a lobectomy.

VATS

Open surgery PROCEDURE

Patients undergo a standard open operation for stage II-III lung cancer called a lobectomy.

open surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stage II-III non-small cell lung cancer by CT and PET-CT and requiring radical surgery for lung cancer;
• Age ≥ 18 years.

You may not qualify if:

• palliative surgery;
• previous thoracic surgery;
• chest wall resection;
• Pancoast tumors;
• reconstruction of carina.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, 200020, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Thoracic Surgery, Video-Assisted; Conversion to Open Surgery

Condition Hierarchy (Ancestors)

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

Central Study Contacts

liang duan, doctor

CONTACT

+8613044634176; duan-liang@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 5, 2019
• Study Start: June 1, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

CN (1)