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出境医 / 临床实验 / VATS VS. Open Thoracic Surgery for Stage II - III Lung Cancer (VOLCANO)

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

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Surgery Procedure: VATS Procedure: Open surgery Phase 3

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: VATS
Patients undergo a standard VATS operation for stage II-III lung cancer
Procedure: VATS
Patients undergo a standard VATS operation for stage II-III lung cancer called a lobectomy.

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

Outcome Measures
Primary Outcome Measures :
  1. disease free survival after surgery [ Time Frame: 3 years ]
    Determine if VATS provides a non inferior oncologic control to open Lobectomy, as measure by 3-year progression free survival.


Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: 6 month ]
    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 ".

  2. Quality of life [ Time Frame: 6 month ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: liang duan, doctor +8613044634176 ext +8613044634176 duan-liang@163.com

Locations
Layout table for location information
China
Shanghai Pulmonary Hospital Recruiting
Shanghai, China, 200020
Contact: liang duan    +8613044634176    duan-liang@163.com   
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
disease free survival after surgery [ Time Frame: 3 years ]
Determine if VATS provides a non inferior oncologic control to open Lobectomy, as measure by 3-year progression free survival.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
disease free survival after surgery [ Time Frame: 3 years ]
3 years DFS
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • Postoperative pain [ Time Frame: 6 month ]
    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 [ Time Frame: 6 month ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Postoperative pain [ Time Frame: 6 month ]
    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 [ Time Frame: 6 month ]
    EORTC QLQ-C43 questionnaire is used.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VATS VS. Open Thoracic Surgery for Stage II - III Lung Cancer
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Surgery
Intervention  ICMJE
  • Procedure: VATS
    Patients undergo a standard VATS operation for stage II-III lung cancer called a lobectomy.
  • Procedure: Open surgery
    Patients undergo a standard open operation for stage II-III lung cancer called a lobectomy.
Study Arms  ICMJE
  • Experimental: VATS
    Patients undergo a standard VATS operation for stage II-III lung cancer
    Intervention: Procedure: VATS
  • Active Comparator: open surgery
    Patients undergo a standard open operation for stage II-III lung cancer
    Intervention: Procedure: Open surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2025
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: liang duan, doctor +8613044634176 ext +8613044634176 duan-liang@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009915
Other Study ID Numbers  ICMJE Duanliang 1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party duan liang, Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor  ICMJE Shanghai Pulmonary Hospital, Shanghai, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Pulmonary Hospital, Shanghai, China
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP