Clinical trial NCT02617186: Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT
Official title: Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Thoracic Surgery
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: University of Toronto / Toronto General Hospital
name: University of Florida
name: University Hospital, Rouen
name: St Vincent's Hospital Melbourne
name: University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia)
name: University of Melbourne / Barwon Health (Geelong, Australia)
First posted: 2015-11-30
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the surgeons increased range of motion during the surgery, and research demonstrates that RTS has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a prospective manner.

There are two major barriers against the widespread adoption of robotic thoracic surgery. The first barrier is the lack of high-quality prospective data. To our knowledge, there are no prospective trials comparing VATS to RTS for early stage lung cancer. The second major barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy for early stage lung cancer.

Prospective randomization will eliminate the biases of retrospective data and will serve to determine whether there exist any advantages to Health Related Quality of life (HRQOL) or patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a prospective cost-utility analysis, this trial will provide the highest quality data to evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian health system.


Eligibility criteria: Inclusion Criteria:

1. Age \>/= 18 years
2. Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
3. Candidates for minimally invasive pulmonary lobectomy, as determined by the operating surgeon.

Exclusion Criteria:

1. Clinical stage IIIb or IV NSCLC
2. Not a candidate for minimally invasive surgery.

Primary outcomes:
measure: Difference in HRQOL scores at week 12 between the treatment groups
timeFrame: 12 weeks post-surgery
Secondary outcomes:
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Short-term clinical outcome differences
timeFrame: 3 weeks post-surgery
measure: Resource utilization
timeFrame: 1 year post-surgery
measure: Resource utilization
timeFrame: 1 year post-surgery
measure: Resource utilization
timeFrame: 1 year post-surgery
measure: Resource utilization
timeFrame: 1 year post-surgery
measure: Resource utilization
timeFrame: 1 year post-surgery
measure: Resource utilization
timeFrame: 1 year post-surgery
measure: Resource utilization
timeFrame: 1 year post-surgery
measure: Resource utilization
timeFrame: 1 year post-surgery
measure: Cost Effectiveness
timeFrame: 5 years post-surgery
measure: Difference in HRQOL scores between the treatment groups
timeFrame: 3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgery
measure: Difference in 5-year survival rate between the two groups
timeFrame: 5 years post-surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University / St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Waël C Hanna, MDCM, MBA, FRCSC
role: PRINCIPAL_INVESTIGATOR
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