Lung NeoplasmsVIOLETNCT03521375
VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer
A study testing Open Surgery and Video Assisted Thoracoscopic Surgery (VATS) in people with Lung Neoplasms, run by University of Bristol at 9 sites in United Kingdom.
Trial summary
Lung cancer is the leading cause of cancer death worldwide and survival in the United Kingdom (UK) remains amongst the lowest in Europe. Surgery is the main method of managing early stage disease and is traditionally undertaken via conventional open surgery. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Open Surgery and Video Assisted Thoracoscopic Surgery (VATS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Jul 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged ≥16 years of age
- Able to give written consent, undergoing either:
- Lobectomy or bilobectomy for treatment of known or suspected primary lung cancer beyond lobar orifice* in TNM8 stage cT1-3 (by size criteria, equivalent to TNM7 stage cT1a-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0-1 and M0 or ii. Undergoing frozen section biopsy with the intention to proceed with lobectomy or bilobectomy if primary lung cancer with a peripheral tumour beyond a lobar orifice* in TNM8 stage cT1-3 (by size criteria, equivalent to TNM7 stage cT1a-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0-1 and M0 is confirmed
- Disease suitable for both minimal access (VATS) and open surgery
Who cannot join
- Adults lacking capacity to consent
- Previous malignancy that influences life expectancy
- Patients in whom a pneumonectomy, segmentectomy or non-anatomic resection (e.g. wedge resection) is planned
- Patients with a serious concomitant disorder that would compromise patient safety during surgery.
- Planned robotic surgery
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Heartlands Hospital
Birmingham
Bristol Royal Infirmary
Bristol
Royal Infirmary of Edinburgh
Edinburgh
Hull and East Yorkshire Hospitals NHS Trust
Hull
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
Harefield Hospital
London
Royal Brompton Hospital
London
The James Cook University Hospital
Middlesbrough
Oxford University Hospitals NHS Foundation Trust
Oxford
About this study
Official title: VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer, a Multi-centre Randomised Controlled Trial With an Internal Pilot
Lung cancer is the leading cause of cancer death worldwide and survival in the United Kingdom (UK) remains amongst the lowest in Europe. Surgery is the main method of managing early stage disease and is traditionally undertaken via conventional open surgery. However, over the last decade there has been a surge in the number of minimal access resections performed using Video-assisted thoracoscopic surgery (VATS). However, there remains a need for well-designed and conducted randomised controlled trial (RCT) to provide the evidence base for the wide spread uptake and delivery of this surgical approach.
Read the detailed description
The uptake of surgery for lung cancer in the UK is low and minimal access surgery may be regarded as a more acceptable intervention (compared to open surgery) by patients, referring respiratory physicians and oncologists. However, a large multi-centre RCT is essential to inform patient and clinician decision making and influence surgical practice in the UK.
The VIOLET study will compare the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open surgery for treatment of lung cancer and will test the hypothesis that VATS surgery is superior to open surgery with respect to self-reported physical function five weeks after randomisation (approx. one month after surgery).
Specific objectives are to estimate:
- The difference between groups in the average self-reported physical function at five weeks.
- The difference between groups with respect to a range of secondary outcomes including assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pN2 disease and disease free survival) and overall survival.
- The cost effectiveness of VATs and open surgery.
- Conditions
- Lung Neoplasms
- Being tested
- Open Surgery, Video Assisted Thoracoscopic Surgery (VATS)
- Keywords
- lung, cancer, lobectomy
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open SurgeryProcedure or surgery
Also called Open lobectomy
Conventional open surgery is undertaken through a single incision +/- rib resection and with rib spreading. The operation is performed under direct vision with isolation of the hilar structures (vein, artery and bronchus) which are dissected, ligated and divided in sequence and the lobe of lung resected. The procedures may be undertaken using ligatures, over sewing or with staplers. Lymph node management is undertaken in accordance with the International Association of the Study of Lung Cancer (IASLC) recommendations where a minimal of 6 nodes / stations are removed, of which 3 are from the mediastinum that includes the subcarinal station. The thoracotomy is closed in layers starting from pericostal sutures over the ribs, muscle, fat and skin layers.
Video Assisted Thoracoscopic Surgery (VATS)Procedure or surgery
Also called VATS lobectomy
VATS lobectomy is undertaken through one to four keyhole incisions without rib spreading. The use of 'rib spreading' is prohibited as this is the key intra-operative manoeuvre which disrupts tissues and causes pain (and is used in open surgery). The procedure is performed with videoscopic visualisation without direct vision. The hilar structures are dissected, stapled and divided. Endoscopic ligation of pulmonary arterial branches may be performed. The fissure is completed and the lobe of lung resected. Lymph node management is the same as described for open surgery. The incisions are closed in layers and may involve muscle, fat and skin layers. This definition of VATS lobectomy is a modification of CALGB 39802.
| Study group | Role | What they receive |
|---|---|---|
| VATS lobectomy | Experimental | VATS lobectomy is undertaken through one to four keyhole incisions without rib spreading. The use of 'rib spreading' is prohibited as this is the key intra-operative manoeuvre which disrupts tissues and causes pain (and is used in open surgery). The procedure is performed with videoscopic visualisation without direct vision. The hilar structures are dissected, stapled and divided. Endoscopic ligation of pulmonary arterial branches may be performed. The fissure is completed and the lobe of lung resected. Lymph node management is the same as described for open surgery. The incisions are closed in layers and may involve muscle, fat and skin layers. This definition of VATS lobectomy is a modification of CALGB 39802. Receives: Procedure: Video Assisted Thoracoscopic Surgery (VATS) |
| Open lobectomy | Active comparator | Conventional open surgery is undertaken through a single incision +/- rib resection and with rib spreading. The operation is performed under direct vision with isolation of the hilar structures (vein, artery and bronchus) which are dissected, ligated and divided in sequence and the lobe of lung resected. The procedures may be undertaken using ligatures, over sewing or with staplers. Lymph node management is undertaken in accordance with the International Association of the Study of Lung Cancer (IASLC) recommendations where a minimal of 6 nodes / stations are removed, of which 3 are from the mediastinum that includes the subcarinal station. The thoracotomy is closed in layers starting from pericostal sutures over the ribs, muscle, fat and skin layers. Receives: Procedure: Open Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported physical function using HRQoL questionnaire QLQ-C30
Physical functioning scale, ranges between 0 and 100. High score indicates high level of physical functioning.
Measured: 5 weeks post randomisation
Secondary outcomes (12)
Time from surgery to hospital discharge, assessed up to 12 months
Measured: Time from surgery to hospital discharge, assessed up to 12 months
Adverse health events to 1 year
Measured: Adverse health events to 1 year
Proportion of patients taking up adjuvant treatment, assessed up to 12 months
Measured: Proportion and time to uptake of adjuvant treatment, assessed up to 12 months
Time to uptake of adjuvant treatment, assessed up to 12 months
Measured: Proportion and time to uptake of adjuvant treatment, assessed up to 12 months
Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post surgery
Measured: Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post-surgery
Overall and disease-free survival to 1-year
Measured: 1 year
Proportion of patients who undergo complete resection during the procedure, , assessed up to 12 months
Measured: Proportion of patients who undergo complete resection during the procedure, assessed up to 12 months
Proportion of patients who experience prolonged incision pain (defined as the need of analgesia > 5 weeks post-randomisation)
Measured: Up to 1 year
Disease-specific HRQoL - EORTC QLQ-C30 to 1-year
3 types of scales. Functioning scales which include physical functioning, role functioning, emotional function, cognitive functioning and social functioning. Symptom scales which include fatigue, nausea and vomiting, pain, dysponea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties.
An overall global health status/QoL All scales range between 0 and 100. For functioning scales, a high score indicates a high level of functioning. Similarly, a high global health status/QoL score indicates a high quality of life. For symptom scales, a high score indicates a high level of symptoms.
Measured: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation
Disease-specific HRQoL - EORTC QLQ-LC13 to 1-year
Symptoms scales which include Dyspnoea, Couging, Haemoptysis, Sore mouth, Dysphagia, Peripheral neuropathy, Alopecia, Pain in chest, Pain in arm or shoulder, Pain in other parts, and Pain medication. For these scales, a high score indicates a high level of symptoms, as with the QLQ-C30.
Scales range between 0 and 100.
Measured: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation
Generic HRQoL - EORTC EQ5D to 1-year
Subscales: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. These range from 1-5.
subscales mobility, self-care, usual activities, pain/discomfort, anxiety/depression are combined to calculate an overall index score which ranges from -0.59 to 1.
A higher score indicates better quality of life
Measured: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation
Resource use
Resource use to 1-year (measured for the duration of post-operative hospital stay until discharge, and at 5 weeks, 3 months, 6 months and 1-year post randomisation)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study startJul 2015
- Primary completionMar 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Chris Rogers, Study director, University of BristolEric Lim, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521375
- Sponsor's protocol ID
- ORCA58877
- Acronym
- VIOLET
- Status last verified
- Sep 2020
- First submitted
- 26 Jan 2018
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lim E, Batchelor T, Shackcloth M, Dunning J, McGonigle N, Brush T, Dabner L, Harris R, Mckeon HE, Paramasivan S, Elliott D, Stokes EA, Wordsworth S, Blazeby J, Rogers CA; VIOLET Trialists. Study protocol for VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a UK multicentre randomised controlled trial with an internal pilot (the VIOLET study). BMJ Open. 2019 Oct 14;9(10):e029507. doi: 10.1136/bmjopen-2019-029507.
PubMed 31615795
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer, a Multi-centre Randomised Controlled Trial With an Internal Pilot
- ClinicalTrials.gov ID
- NCT03521375
- Acronym / sponsor ID
- VIOLET / ORCA58877
- Conditions
- Lung Neoplasms
- Keywords
- lung, cancer, lobectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, University of Oxford
- Study start
- Jul 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is the leading cause of cancer death worldwide and survival in the United Kingdom (UK) remains amongst the lowest in Europe. Surgery is the main method of managing early stage disease and is traditionally undertaken via conventional open surgery. However, over the last decade there has been a surge in the number of minimal access resections performed using Video-assisted thoracoscopic surgery (VATS). However, there remains a need for well-designed and conducted randomised controlled trial (RCT) to provide the evidence base for the wide spread uptake and delivery of this surgical approach.
Detailed description
The uptake of surgery for lung cancer in the UK is low and minimal access surgery may be regarded as a more acceptable intervention (compared to open surgery) by patients, referring respiratory physicians and oncologists. However, a large multi-centre RCT is essential to inform patient and clinician decision making and influence surgical practice in the UK.
The VIOLET study will compare the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open surgery for treatment of lung cancer and will test the hypothesis that VATS surgery is superior to open surgery with respect to self-reported physical function five weeks after randomisation (approx. one month after surgery).
Specific objectives are to estimate:
- The difference between groups in the average self-reported physical function at five weeks.
- The difference between groups with respect to a range of secondary outcomes including assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pN2 disease and disease free survival) and overall survival.
- The cost effectiveness of VATs and open surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS lobectomy | Experimental | Procedure: Video Assisted Thoracoscopic Surgery (VATS)VATS lobectomy is undertaken through one to four keyhole incisions without rib spreading. The use of 'rib spreading' is prohibited as this is the key intra-operative manoeuvre which disrupts tissues and causes pain (and is used in open surgery). The procedure is performed with videoscopic visualisation without direct vision. The hilar structures are dissected, stapled and divided. Endoscopic ligation of pulmonary arterial branches may be performed. The fissure is completed and the lobe of lung resected. Lymph node management is the same as described for open surgery. The incisions are closed in layers and may involve muscle, fat and skin layers. This definition of VATS lobectomy is a modification of CALGB 39802. |
| Open lobectomy | Active comparator | Procedure: Open SurgeryConventional open surgery is undertaken through a single incision +/- rib resection and with rib spreading. The operation is performed under direct vision with isolation of the hilar structures (vein, artery and bronchus) which are dissected, ligated and divided in sequence and the lobe of lung resected. The procedures may be undertaken using ligatures, over sewing or with staplers. Lymph node management is undertaken in accordance with the International Association of the Study of Lung Cancer (IASLC) recommendations where a minimal of 6 nodes / stations are removed, of which 3 are from the mediastinum that includes the subcarinal station. The thoracotomy is closed in layers starting from pericostal sutures over the ribs, muscle, fat and skin layers. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥16 years of age
- Able to give written consent, undergoing either:
- Disease suitable for both minimal access (VATS) and open surgery
Key exclusion criteria (5 listed)
- Adults lacking capacity to consent
- Previous malignancy that influences life expectancy
- Patients in whom a pneumonectomy, segmentectomy or non-anatomic resection (e.g. wedge resection) is planned
- Patients with a serious concomitant disorder that would compromise patient safety during surgery.
- Planned robotic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open SurgeryAlso: Open lobectomyConventional open surgery is undertaken through a single incision +/- rib resection and with rib spreading. The operation is performed under direct vision with isolation of the hilar structures (vein, artery and bronchus) which are dissected, ligated and divided in sequence and the lobe of lung resected. The procedures may be undertaken using ligatures, over sewing or with staplers. Lymph node management is undertaken in accordance with the International Association of the Study of Lung Cancer (IASLC) recommendations where a minimal of 6 nodes / stations are removed, of which 3 are from the mediastinum that includes the subcarinal station. The thoracotomy is closed in layers starting from pericostal sutures over the ribs, muscle, fat and skin layers. | Procedure or surgery | Open lobectomy |
| Video Assisted Thoracoscopic Surgery (VATS)Also: VATS lobectomyVATS lobectomy is undertaken through one to four keyhole incisions without rib spreading. The use of 'rib spreading' is prohibited as this is the key intra-operative manoeuvre which disrupts tissues and causes pain (and is used in open surgery). The procedure is performed with videoscopic visualisation without direct vision. The hilar structures are dissected, stapled and divided. Endoscopic ligation of pulmonary arterial branches may be performed. The fissure is completed and the lobe of lung resected. Lymph node management is the same as described for open surgery. The incisions are closed in layers and may involve muscle, fat and skin layers. This definition of VATS lobectomy is a modification of CALGB 39802. | Procedure or surgery | VATS lobectomy |
Primary outcome
Self-reported physical function using HRQoL questionnaire QLQ-C30
Time frame: 5 weeks post randomisation
Physical functioning scale, ranges between 0 and 100. High score indicates high level of physical functioning.
12 secondary outcomes
Time from surgery to hospital discharge, assessed up to 12 months
Time frame: Time from surgery to hospital discharge, assessed up to 12 months
Adverse health events to 1 year
Time frame: Adverse health events to 1 year
Proportion of patients taking up adjuvant treatment, assessed up to 12 months
Time frame: Proportion and time to uptake of adjuvant treatment, assessed up to 12 months
Time to uptake of adjuvant treatment, assessed up to 12 months
Time frame: Proportion and time to uptake of adjuvant treatment, assessed up to 12 months
Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post surgery
Time frame: Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post-surgery
Overall and disease-free survival to 1-year
Time frame: 1 year
Proportion of patients who undergo complete resection during the procedure, , assessed up to 12 months
Time frame: Proportion of patients who undergo complete resection during the procedure, assessed up to 12 months
Proportion of patients who experience prolonged incision pain (defined as the need of analgesia > 5 weeks post-randomisation)
Time frame: Up to 1 year
Disease-specific HRQoL - EORTC QLQ-C30 to 1-year
Time frame: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation
Disease-specific HRQoL - EORTC QLQ-LC13 to 1-year
Time frame: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation
Generic HRQoL - EORTC EQ5D to 1-year
Time frame: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation
Resource use
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Background: PubMed 31615795Lim E, Batchelor T, Shackcloth M, Dunning J, McGonigle N, Brush T, Dabner L, Harris R, Mckeon HE, Paramasivan S, Elliott D, Stokes EA, Wordsworth S, Blazeby J, Rogers CA; VIOLET Trialists. Study protocol for VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a UK multicentre randomised controlled trial with an internal pilot (the VIOLET study). BMJ Open. 2019 Oct 14;9(10):e029507. doi: 10.1136/bmjopen-2019-029507.
- Protocol paper publicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Rogers study director
University of Bristol
Eric Lim principal investigator
Royal Brompton & Harefield NHS Foundation Trust
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Surgery and Video Assisted Thoracoscopic Surgery (VATS) in people with Lung Neoplasms, run by University of Bristol at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported physical function using HRQoL questionnaire QLQ-C30 (time frame: 5 weeks post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03521375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.