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.
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: A. The difference between groups in the average self-reported physical function at five weeks. B. 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. C. The cost effectiveness of VATs and open surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
503
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.
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.
Heartlands Hospital
Birmingham, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
Harefield Hospital
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
The James Cook University Hospital
Middlesbrough, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
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.
Time frame: 5 weeks post randomisation
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
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.
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
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.
Time frame: 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
Time frame: 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)
Time frame: Up to 1 year
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