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

Lung Cancer Clinical Trial

— VOLCANO  

Official title:

Comparison of Curative Effect and Postoperative Survival Rate Between Video-assisted Thoracoscopic Surgery and Open Thoracic Surgery for Stage II - III Lung Cancer, A Prospective, Randomized, Controlled Trial: (The VOLCANO Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04009915
• Other study ID #: Duanliang 1
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2019
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2022
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: liang duan, doctor
• Phone: +8613044634176
• Email: duan-liang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Lung cancer is the most common malignant tumor in the world. Surgical treatment is the first and most important treatment for lung cancer. It can completely remove the primary lesions of lung cancer and metastasis of lymph nodes to achieve clinical cure. Opening the chest into the chest allows for an excellent surgical field of view, but it is usually necessary to divide the pectoralis and separate the ribs. To prevent these shortcomings, in the early 1990s, video-assisted thoracoscopic surgery (VATS) was first applied to anatomical pneumonectomy and proved to be safe and feasible. Nowadays, 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.

For lung cancer, the benefit of VATS over open surgery is mainly due to the reduction of surgical trauma and the relative maintenance of chest integrity, the reduction of immune function, the reduction of postoperative pain, and the preservation of lung and shoulder function. What's more, the incidence of postoperative complications is reduced, patients recover faster, hospitalization is short, and normal activities are restored early. 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. the investigators would complete the real and effective accumulation of data through strict enrollment, detailed records, and regular follow-up, in order to provide suggestions for the development of new guidelines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of stage II-III non-small cell lung cancer by CT and PET-CT and requiring radical surgery for lung cancer;

2. Age = 18 years.

Exclusion Criteria:

1. palliative surgery;

2. previous thoracic surgery;

3. chest wall resection;

4. Pancoast tumors;

5. reconstruction of carina.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Surgery

Intervention

Procedure:
• VATS
Patients undergo a standard VATS operation for stage II-III lung cancer called a lobectomy.
• Open surgery
Patients undergo a standard open operation for stage II-III lung cancer called a lobectomy.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative pain	Numericrating scale (NRS) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".	6 month
Secondary	Quality of life	The EQ5D questionnaire consists of five questions (primary dimensions) about mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, which all have three possible answers ("no problems", "some problems", or "extreme problems"). Additionally, EQ5D includes self-reported overall quality of life as a linear 100 point scale, where 0 is the worst imaginable health state and 100 is the best imaginable health state. EORTC QLQ-C30 is a 30-item questionnaire, from which six functional domains of quality of life (physical function, emotional function, cognitive function, social function, and role function), and nine symptom domains (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite, constipation, diarrhoea, and financial difficulties) can be extracted, as well as an overall score.	6 month