VATS VS. Open Thoracic Surgery for Stage II - III Lung Cancer (VOLCANO)
Primary Purpose
Lung Cancer, Surgery
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
VATS
Open surgery
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- palliative surgery;
- previous thoracic surgery;
- chest wall resection;
- Pancoast tumors;
- reconstruction of carina.
Sites / Locations
- Shanghai Pulmonary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VATS
open surgery
Arm Description
Patients undergo a standard VATS operation for stage II-III lung cancer
Patients undergo a standard open operation for stage II-III lung cancer
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 ".
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.
Full Information
NCT ID
NCT04009915
First Posted
July 3, 2019
Last Updated
May 5, 2022
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
1. Study Identification
Unique Protocol Identification Number
NCT04009915
Brief Title
VATS VS. Open Thoracic Surgery for Stage II - III Lung Cancer
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VATS
Arm Type
Experimental
Arm Description
Patients undergo a standard VATS operation for stage II-III lung cancer
Arm Title
open surgery
Arm Type
Active Comparator
Arm Description
Patients undergo a standard open operation for stage II-III lung cancer
Intervention Type
Procedure
Intervention Name(s)
VATS
Intervention Description
Patients undergo a standard VATS operation for stage II-III lung cancer called a lobectomy.
Intervention Type
Procedure
Intervention Name(s)
Open surgery
Intervention Description
Patients undergo a standard open operation for stage II-III lung cancer called a lobectomy.
Primary Outcome Measure Information:
Title
disease free survival after surgery
Description
Determine if VATS provides a non inferior oncologic control to open Lobectomy, as measure by 3-year progression free survival.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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 ".
Time Frame
6 month
Title
Quality of life
Description
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.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
palliative surgery;
previous thoracic surgery;
chest wall resection;
Pancoast tumors;
reconstruction of carina.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
liang duan, doctor
Phone
+8613044634176
Ext
+8613044634176
Email
duan-liang@163.com
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liang duan
Phone
+8613044634176
Email
duan-liang@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
VATS VS. Open Thoracic Surgery for Stage II - III Lung Cancer
We'll reach out to this number within 24 hrs