Study Summary
This trial will help determine if robotic technology is better than traditional methods for early stage lung cancer surgery.
Eligible Conditions
- Thoracic Surgery
- Non-Small Cell Lung Cancer
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 5 years post-surgery
1 year post-surgery
Resource utilization
12 weeks post-surgery
Difference in HRQOL scores at week 12 between the treatment groups
3 weeks post-surgery
Short-term clinical outcome differences
Year 5
Difference in HRQOL scores between the treatment groups
5 years post-surgery
Cost Effectiveness
Difference in 5-year survival rate between the two groups
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Thoracoscopic Lobectomy
1 of 2
Robotic Lobectomy
1 of 2
Active Control
592 Total Participants · 2 Treatment Groups
Primary Treatment: Thoracoscopic Lobectomy · No Placebo Group · N/A
Thoracoscopic Lobectomy
Procedure
ActiveComparator Group · 1 Intervention: Video-assisted thoracoscopic surgery · Intervention Types: ProcedureRobotic Lobectomy
Procedure
ActiveComparator Group · 1 Intervention: Robotic thoracic surgery · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years post-surgery
Who is running the clinical trial?
University of Toronto / Toronto General HospitalUNKNOWN
University of FloridaOTHER
1,274 Previous Clinical Trials
699,574 Total Patients Enrolled
Rouen Normandy University / CHU-Hopitaux de Rouen (Rouen, France)UNKNOWN
St Vincent's Hospital MelbourneOTHER
27 Previous Clinical Trials
6,684 Total Patients Enrolled
University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia)UNKNOWN
University of Melbourne / Barwon Health (Geelong, Australia)UNKNOWN
St. Joseph's Healthcare HamiltonLead Sponsor
187 Previous Clinical Trials
24,953 Total Patients Enrolled
1 Trials studying Thoracic Surgery
Waël C Hanna, MDCM, MBA, FRCSCPrincipal InvestigatorMcMaster University
3 Previous Clinical Trials
150 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have early-stage non-small cell lung cancer that has not spread too far.
The surgeon has determined that you are a suitable candidate for minimally invasive surgery to remove a part of your lung.
References
- Nasir, Basil S., Ayesha S. Bryant, Douglas J. Minnich, Ben Wei, and Robert J. Cerfolio. 2014. “Performing Robotic Lobectomy and Segmentectomy: Cost, Profitability, and Outcomes”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2014.02.051.
- Wei, Benjamin, and Thomas A. D’Amico. 2014. “Thoracoscopic Versus Robotic Approaches”. Thoracic Surgery Clinics. Elsevier BV. doi:10.1016/j.thorsurg.2014.02.001.
- Merritt, Robert E., Chuong D. Hoang, and Joseph B. Shrager. 2013. “Lymph Node Evaluation Achieved by Open Lobectomy Compared with Thoracoscopic Lobectomy for N0 Lung Cancer”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2013.05.044.
- Park, Bernard J., Franca Melfi, Alfredo Mussi, Patrick Maisonneuve, Lorenzo Spaggiari, Ruy Kuenzer Caetano Da Silva, and Giulia Veronesi. 2012. “Robotic Lobectomy for Non–small Cell Lung Cancer (NSCLC): Long-term Oncologic Results”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2011.10.055.
- Kent, Michael, Thomas Wang, Richard Whyte, Thomas Curran, Raja Flores, and Sidhu Gangadharan. 2014. “Open, Video-assisted Thoracic Surgery, and Robotic Lobectomy: Review of a National Database”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2013.07.117.
- Paul, Subroto, Jessica Jalbert, Abby J. Isaacs, Nasser K. Altorki, O. Wayne Isom, and Art Sedrakyan. 2014. “Comparative Effectiveness of Robotic-assisted Vs Thoracoscopic Lobectomy”. Chest. Elsevier BV. doi:10.1378/chest.13-3032.
- Cerfolio, Robert J.. 2014. “Total Port Approach for Robotic Lobectomy”. Thoracic Surgery Clinics. Elsevier BV. doi:10.1016/j.thorsurg.2014.02.006.
- “Euroqol - a New Facility for the Measurement of Health-related Quality of Life”. 1990. “Euroqol - a New Facility for the Measurement of Health-related Quality of Life”. Health Policy. Elsevier BV. doi:10.1016/0168-8510(90)90421-9.
- Ujiie, Hideki, Alexander Gregor, and Kazuhiro Yasufuku. 2019. “Minimally Invasive Surgical Approaches for Lung Cancer”. Expert Review of Respiratory Medicine. Informa UK Limited. doi:10.1080/17476348.2019.1610399.
- Cerfolio, Robert J., and Ayesha S. Bryant. 2013. “How to Teach Robotic Pulmonary Resection”. Seminars in Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1053/j.semtcvs.2013.01.004.
- Pickard, A Simon, Maureen P Neary, and David Cella. 2007. “Estimation of Minimally Important Differences in EQ-5D Utility and VAS Scores in Cancer”. Health and Quality of Life Outcomes. Springer Science and Business Media LLC. doi:10.1186/1477-7525-5-70.
- Veronesi, Giulia. 2014. “Robotic Thoracic Surgery”. Thoracic Surgery Clinics. Elsevier BV. doi:10.1016/j.thorsurg.2014.02.009.
- Louie, Brian E., Alexander S. Farivar, Ralph W. Aye, and Eric Vallières. 2012. “Early Experience with Robotic Lung Resection Results in Similar Operative Outcomes and Morbidity When Compared with Matched Video-assisted Thoracoscopic Surgery Cases”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2012.01.067.
- D'Amico, Thomas A., Joyce Niland, Rizvan Mamet, Carrie Zornosa, Elisabeth U. Dexter, and Mark W. Onaitis. 2011. “Efficacy of Mediastinal Lymph Node Dissection During Lobectomy for Lung Cancer by Thoracoscopy and Thoracotomy”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2011.03.134.
- Grogan, Eric L., and David R. Jones. 2008. “VATS Lobectomy Is Better Than Open Thoracotomy: What Is the Evidence for Short-term Outcomes?”. Thoracic Surgery Clinics. Elsevier BV. doi:10.1016/j.thorsurg.2008.04.007.
- Research Electronic Data Capture (RedCap). http://www.project-redcap.org
- Louie, Brian E., Alexander S. Farivar, Ralph W. Aye, and Eric Vallières. 2012. “Early Experience with Robotic Lung Resection Results in Similar Operative Outcomes and Morbidity When Compared with Matched Video-assisted Thoracoscopic Surgery Cases”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2012.01.067.
- Onaitis MW, Petersen RP, Balderson SS, et al. Thoracoscopic Lobectomy Is a Safe and Versatile Procedure. Transactions of the Meeting of the American Surgical Association. 2006;124:86-91. doi:10.1097/01.sla.0000234892.79056.63.
- Hanna, WC., Fahim, C., Patel, P., Shargall, Y., Waddell TK., Yasufuku, K. (2015). Robotic Pulmonary Resection for Lung Cancer: The First Canadian Series. Abstract Accepted for podium presentation at Canadian Association of Thoracic Surgeons (CATS) 18th Annual Meeting, September 17-20, Quebec, QC.
- Little, R.J.A. and Rubin, D.B. (1987) Statistical Analysis with Missing Data. J. Wiley & Sons, New York.
- SAS Institute Inc., SAS 9.4 Help and Documentation, Cary, NC: SAS Institute Inc., 2000-2012.
- Patel, Yogita S., Waël C. Hanna, Christine Fahim, Yaron Shargall, Thomas K. Waddell, Kazuhiro Yasufuku, Tiago N. Machuca, et al.. 2022. “RAVAL Trial: Protocol of an International, Multi-centered, Blinded, Randomized Controlled Trial Comparing Robotic-assisted Versus Video-assisted Lobectomy for Early-stage Lung Cancer”. Edited by Robert Jeenchen Chen. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0261767.
- Louie BE, Farivar AS, Aye RW, Vallieres E. Early experience with robotic lung resection results in similar operative outcomes and morbidity when compared with matched video-assisted thoracoscopic surgery cases. Ann Thorac Surg. 2012 May;93(5):1598-604; discussion 1604-5. doi: 10.1016/j.athoracsur.2012.01.067. Epub 2012 Mar 20.
- Cerfolio RJ, Bryant AS. How to teach robotic pulmonary resection. Semin Thorac Cardiovasc Surg. 2013 Spring;25(1):76-82. doi: 10.1053/j.semtcvs.2013.01.004. No abstract available.
- EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
- Veronesi G. Robotic thoracic surgery: technical considerations and learning curve for pulmonary resection. Thorac Surg Clin. 2014 May;24(2):135-41, v. doi: 10.1016/j.thorsurg.2014.02.009.
- Wei B, D'Amico TA. Thoracoscopic versus robotic approaches: advantages and disadvantages. Thorac Surg Clin. 2014 May;24(2):177-88, vi. doi: 10.1016/j.thorsurg.2014.02.001.
- Pickard AS, Neary MP, Cella D. Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes. 2007 Dec 21;5:70. doi: 10.1186/1477-7525-5-70. Erratum In: Health Qual Life Outcomes. 2010;8:4.
- Cerfolio RJ. Total port approach for robotic lobectomy. Thorac Surg Clin. 2014 May;24(2):151-6, v. doi: 10.1016/j.thorsurg.2014.02.006.
- Grogan EL, Jones DR. VATS lobectomy is better than open thoracotomy: what is the evidence for short-term outcomes? Thorac Surg Clin. 2008 Aug;18(3):249-58. doi: 10.1016/j.thorsurg.2008.04.007.
- Ujiie H, Gregor A, Yasufuku K. Minimally invasive surgical approaches for lung cancer. Expert Rev Respir Med. 2019 Jun;13(6):571-578. doi: 10.1080/17476348.2019.1610399. Epub 2019 May 6.
- Wael Hanna 2016. "Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02617186.
Frequently Asked Questions
Is enrollment for this experiment still open?
"According to records published on clinicaltrials.gov, this experiment is still recruiting patients. The initial post was made in January 2016 and the trial was recently updated in November 2022." - Anonymous Online Contributor
Unverified Answer
How many participants are being recruited for this medical experiment?
"Indeed, clinicaltrials.gov indicates that this trial is actively recruiting participants. It was first listed on January 1st 2016 and the most recent update occurred on November 2nd 2022. The study requires a total of 592 patients from one facility to be enrolled in order to commence its research agenda." - Anonymous Online Contributor
Unverified Answer