Clinical trial NCT03521375: VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer
Official title: VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer, a Multi-centre Randomised Controlled Trial With an Internal Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Keywords: lung
cancer
lobectomy
Lead sponsor: University of Bristol
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
name: University of Oxford
First posted: 2018-05-11
Enrollment: 503
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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:

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.

Eligibility criteria: Inclusion Criteria:

1. Adults aged ≥16 years of age
2. Able to give written consent, undergoing either:

   i. 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
3. Disease suitable for both minimal access (VATS) and open surgery

Exclusion Criteria:

1. Adults lacking capacity to consent
2. Previous malignancy that influences life expectancy
3. Patients in whom a pneumonectomy, segmentectomy or non-anatomic resection (e.g. wedge resection) is planned
4. Patients with a serious concomitant disorder that would compromise patient safety during surgery.
5. Planned robotic surgery

Primary outcomes:
measure: Self-reported physical function using HRQoL questionnaire QLQ-C30
timeFrame: 5 weeks post randomisation
Secondary outcomes:
measure: Time from surgery to hospital discharge, assessed up to 12 months
timeFrame: Time from surgery to hospital discharge, assessed up to 12 months
measure: Adverse health events to 1 year
timeFrame: Adverse health events to 1 year
measure: Proportion of patients taking up adjuvant treatment, assessed up to 12 months
timeFrame: Proportion and time to uptake of adjuvant treatment, assessed up to 12 months
measure: Time to uptake of adjuvant treatment, assessed up to 12 months
timeFrame: Proportion and time to uptake of adjuvant treatment, assessed up to 12 months
measure: Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post surgery
timeFrame: Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post-surgery
measure: Overall and disease-free survival to 1-year
timeFrame: 1 year
measure: Proportion of patients who undergo complete resection during the procedure, , assessed up to 12 months
timeFrame: Proportion of patients who undergo complete resection during the procedure, assessed up to 12 months
measure: Proportion of patients who experience prolonged incision pain (defined as the need of analgesia > 5 weeks post-randomisation)
timeFrame: Up to 1 year
measure: Disease-specific HRQoL - EORTC QLQ-C30 to 1-year
timeFrame: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation
measure: Disease-specific HRQoL - EORTC QLQ-LC13 to 1-year
timeFrame: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation
measure: Generic HRQoL - EORTC EQ5D to 1-year
timeFrame: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation
measure: Resource use
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Harefield Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Bristol
name: Chris Rogers
role: STUDY_DIRECTOR
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Eric Lim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.