Lung cancer (stage cT1a-2b N0-1 M0) Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
Trial participants will be randomised to lobectomy via VATS or open surgery in a 1:1 ratio.
Video-assisted thoracoscopic surgery (VATS):
VATS lobectomy is undertaken through one to four keyhole incis
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 08/01/2019: 1. Adults aged =16 years of age 2. Able to give written consent, undergoing either: 2.1. 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 2.2. 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 Previous participant inclusion criteria: 1. Adults aged =16 years of age 2. Able to give written consent, undergoing either: 2.1. Lobectomy for treatment of known or suspected primary lung cancer beyond lobular orifice in stage cT1a-2b N0-1 M0 or 2.2. Undergoing frozen section biopsy with the intention to proceed with lobectomy if primary lung cancer with a peripheral tumour beyond a lobular orifice in stage cT1a-2b N0-1 M0 is confirmed 3. Disease suitable for both minimal access (VATS) and open surgery
Exclusion criteria
Exclusion criteria: 1. Adults lacking capacity to consent 2. Previous malignancy that influences life expectancy 3. Patients in whom a pneumonectomy or non-anatomic resection (e.g. wedge dissection) is planned 4. Patients with a serious concomitant disorder that would compromise patient safety during surgery 5. Planned robotic surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is self-reported physical function (QLQ-C30) at 5 weeks post randomisation. Physical function has been chosen because it is a patient-centred outcome that will reflect the anticipated earlier recovery with video-assisted surgery and has been used in other minimal access surgery trials. The primary endpoint has been chosen to be 5 weeks (1 month post-surgery) to capture the early benefits of minimal access surgery on recovery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/01/2019: 1. Time from surgery to hospital discharge 2. Adverse health events 3. Proportion and time to uptake of adjuvant treatment 4. Proportion of patients upstaged to pN2 disease after the procedure 5. Overall and disease-free survival to 1 year 6. Proportion of patients who undergo complete resection during the procedure 7. Proportion of patients who experience prolonged incision pain (defined as the need of analgesia > 5 weeks after surgery) 8. Generic and disease-specific HRQoL: EORTC QLQ-C30, QLQ-LC13 and EQ5D to 1 year (measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation) 9. Resource use to 1 year (measured for the duration of post-operative hospital stay until discharge, and at 2 weeks, 5 weeks, 3 months, 6 months and 1-year post randomisation) Previous secondary outcome measures: 1. Time from surgery to hospital discharge 2. Adverse health events 3. Proportion and time to uptake of adjuvant treatment 4. Proportion of patients upstaged to pN2 disease after the procedure 5. Overall and disease-free survival to 1 year 6. Proportion of patients who undergo complete resection during the procedure 7. Proportion of patients who experience prolonged incision pain (defined as the need of analgesia > 6 weeks after surgery) 8. Generic and disease-specific HRQoL: EORTC QLQ-C30, QLQ-LC13 and EQ5D to 1 year (measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation) 9. Resource use to 1 year (measured for the duration of post-operative hospital stay until discharge, and at 2 weeks, 5 weeks, 3 months, 6 months and 1-year post randomisation) | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactSurinder Kaur
Outcome results
None listed