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NCT Number: NCT03521375

VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer

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.

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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heartlands Hospital, Birmingham, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥16 years of age
  • 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

  • Disease suitable for both minimal access (VATS) and open surgery

Exclusion criteria

  • 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

Treatment and study plan

Open Surgery

Procedure

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.

Other names: Open lobectomy

Video Assisted Thoracoscopic Surgery (VATS)

Procedure

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.

Other names: VATS lobectomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time from surgery to hospital discharge, assessed up to 12 months

    Time frame: Time from surgery to hospital discharge, assessed up to 12 months

  2. Adverse health events to 1 year

    Time frame: Adverse health events to 1 year

  3. 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

  4. 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

  5. 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

  6. Overall and disease-free survival to 1-year

    Time frame: 1 year

  7. 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

  8. Proportion of patients who experience prolonged incision pain (defined as the need of analgesia > 5 weeks post-randomisation)

    Time frame: Up to 1 year

  9. 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

    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.

  10. 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

    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.

  11. Generic HRQoL - EORTC EQ5D to 1-year

    Time frame: Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation

    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

  12. Resource use

    Time frame: Up to 1 year

    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)

Sponsors and collaborators

Lead sponsor

University of Bristol

Other

Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust
  • University of Oxford

Registry information

Official study title

VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer, a Multi-centre Randomised Controlled Trial With an Internal Pilot

Acronym: VIOLET

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
May 11, 2018
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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