Video Assisted Thoracoscopic Lobectomy Versus Conventional Open Lobectomy For Lung Cancer, A Multi-Centre Randomised Controlled Trial With An Internal Pilot: The VIOLET Study
Funder: NIHR/HTA (project number 13/04/03)
Sponsor: Royal Brompton and Harefield NHS Foundation Trust
REC Number: 14/LO/2129
Status: Recruitment finished to the main study, recruitment to the sub-study is ongoing.
Lung cancer is the leading cause of cancer death worldwide and survival in the UK remains amongst the lowest in Europe. Surgery is the main method of managing early stage disease with over 5000 resections being performed for primary lung cancer within the UK in 2010. Of these, the majority (75%) involved surgical excision of the pulmonary lobe containing the tumour (lobectomy), which is the standard treatment strategy for patients with early stage non-small cell lung cancer.
This type of surgery can be undertaken via traditional open surgery or a form of keyhole surgery called video assisted thoracoscopic surgery (VATS). Both ways of performing the operation are currently used within the NHS and both aim to remove the lobe of the lung containing the tumour. However, at present, we do not know which offers the best treatment and recovery for patients.
Therefore, the aim of the VIOLET study is to generate high quality evidence to compare clinical and patient-reported outcomes between VATS and open surgery in a randomised controlled trial (RCT). A well designed and conducted RCT comparing the effectiveness and cost-effectiveness of VATS and open surgery is urgently needed to inform current NHS practice, health policy and individual surgeon and patient decision-making.
The VIOLET study will involve 500 patients recruited from several hospitals across the UK. The study design includes an internal pilot phase to ensure deliverability of the full RCT.
Whilst surgery involves compete resection of the tumour, disease recurrence is common. Work undertaken at the Royal Brompton Hospital in patients after lung cancer surgery identified 58% patients with detectable cancer DNA in their blood. Identifying the presence of cancer DNA may indicate that cancer is more likely to return and could aid in earlier diagnosis. Therefore, in addition to the main RCT, patients will also be offered the option to participate in a VIOLET sub-study, which aims to determine an association between cancer DNA in the blood and disease recurrence and survival to 5 years.
VIOLET has an embedded sub-study which aims to determine if the presence of molecular residual disease detected in blood samples taken at pre-defined time points after surgery is associated with early cancer recurrence. Consenting participants will have blood drawn at baseline (pre-surgery) and at 5 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months (post-surgery). The blood results of those patients whose cancer returns will be compared to the blood results of those patients who remain cancer-free. The sub-study will continue after recruitment to the main study has finished.
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health.
Chief Investigator: Mr Eric Lim, Consultant Thoracic Surgeon, Royal Brompton Hospital
Study coordinator: Holly McKeon
Further information can be found on Cancer Research UK