Suspended

VOLCANOComparison 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)

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What is being tested

VATS

+ Open surgery

Procedure
Who is being recruted

Lung Diseases+4

+ Lung Neoplasms

+ Neoplasms

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2019
See protocol details

Summary

Principal SponsorShanghai Pulmonary Hospital, Shanghai, China
Study Contactliang duan, doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleComparison 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)
NCT04009915
Principal SponsorShanghai Pulmonary Hospital, Shanghai, China
Study Contactliang duan, doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

2 inclusion criteria required to participate
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.

5 exclusion criteria prevent from participating
palliative surgery;

previous thoracic surgery;

chest wall resection;

Pancoast tumors;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shanghai Pulmonary Hospital

Shanghai, ChinaOpen Shanghai Pulmonary Hospital in Google Maps
SuspendedOne Study Center
VOLCANO | 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) | PatLynk