RoLaCaRT1

Project name: RoLaCaRT1

Full title of study: RoLaCaRT-1: Robotic versus Laparoscopic Colon - a Randomized Trial.  An international randomised phase II trial comparing robotic-assisted right hemicolectomy versus laparoscopic-assisted hemicolectomy for resection of adenocarcinoma of the caecum, ascending or proximal transverse colon.

Lead investigators: Professor Andrew Stevenson, Dr Stephen Pillinger, Dr Craig Lynch, Professor John Simes, Professor Val Gebski.

Collaborators (individuals, nations or Tripartite partners):
Surgeons in Australia, USA and UK will collaborate for this study.  The Australasian Gastrointestinal Trials Group (AGITG) is study sponsor and the NHMRC Clinical Trials Centre at the University of Sydney is the trial coordination centre.

Australian Sites

Steve Pillinger and Craig Lynch Mark Muhlmann and Shing Wong Kirk Austin, Peter Lee, Chris Byrne Sandy Heriot and Craig Lynch Satish Warrier and Sandy Heriot Stephen Bell Andrew Stevenson and Carina Chow Andrew Stevenson Chris Gillespie and Joy Chakraborty Darren Tonkin

Sydney Adventist Hospital (1) - NSW Prince of Wales Private Hospital (2) Royal Prince Alfred Hospital (3) Epworth (4) - VIC Peter MacCallum Cancer Centre (5) Cabrini Malvern (6) Royal Brisbane & Women's Hospital (7) -QLD St Vincent’s Private Northside (8) Mater Misericordiae Private Hospital Brisbane (9) The Queen Elizabeth Hospital (10) - SA

USA Sites

Dave Larson Luca Stocchi and Amit Merchea

Mayo Clinic, Rochester MN (11) Mayo Clinic, Jacksonville, Florida (12)

 UK Sites

Jim Khan Danilo Miskovic

Portsmouth Hospital, UK (13) St Marks Hospital, London (14)

Trial Management Committee &  Regional leadership roles

Name Andrew Stevenson Steve Pillinger Craig Lynch Andrew Clouston Stephen Bell Darren Tonkin David Larson Alessio Pigazzi Larissa Temple Jim Khan Danilo Miskovic Nader Francis Nathan Curtis John Simes Rachel O'Connell Kate Wilson Julie Marker

Expertise Study Chair, Surgery Surgery Surgery Pathology Surgery Surgery Surgery Surgery Surgery Surgery Surgery Surgery Surgery Trial Methodology Statistics Trial Management Consumer Representation

Region Brisbane AU Sydney AU Melbourne AU Brisbane AU Melbourne AU Adelaide AU Rochester MI Ithaca NY NY, USA Portsmouth UK London UK Yeovil, UK Yeovil, UK Sydney AU Sydney AU Sydney AU Sydney AU

Institution Royal Brisbane and Women’s Hospital Sydney Adventist Hospital Epworth Hospital Royal Brisbane and Women’s Hospital / Envoi Pathology Cabrini Malvern Hospital The Queen Elizabeth Hospital Mayo Rochester Cornell University Uni of Rochester Medical Center Porstmouth Hospital St Marks Hospital Yeovil District Hospital Yeovil District Hospital NHMRC CTC, University of Sydney NHMRC CTC, University of Sydney NHMRC CTC, University of Sydney AGITG Consumer Panel

 Surgical Assessment Committee

Name Andrew Stevenson Steve Pillinger Craig Lynch Danilo Miskovic Nader Francis Nathan Curtis

Expertise Surgery Surgery Surgery Surgery Surgery Surgery

Region Brisbane AU Sydney AU Melbourne AU London UK Yeovil, UK Yeovil, UK

Institution Royal Brisbane and Women’s Hospital Sydney Adventist Hospital Epworth Hospital St Marks Hospital Yeovil District Hospital Yeovil District Hospital

Contact email:  RoLaCaRT@ctc.usyd.edu.au
Permission to include project and contact email on Tripartite 2022 website: yes 
Twitter handle if available: not available
Website if available:  https://gicancer.org.au/clinical-trial/rolacart-1/|

Short update on progress so far (180 words max):

This international trial will open in April 2021 at ten sites in Australia, two sites in the UK and two sites in the US.  Overall 21 surgeons will be accredited to join the study.   50 patients will be randomised to either Arm A: (Experimental) Robotic right hemicolectomy (RRHC) with intra/extracorporeal anastomosis (33 patients) or Arm B: (Control) Laparoscopic right hemicolectomy (LRHC) with intra/extracorporeal anastomosis (17 patients).  The randomisation ratio is 2:1 to robotic and stratified by gender, BMI (<30 v >30), tumour site (caecum/ascending colon v. hepatic flexure or proximal transverse colon), surgeon.

The study aims to determine if performing right hemicolectomy robotically compared with laparoscopic hemicolectomy in patients with adenocarcinoma of the caecum, ascending or proximal transverse colon improves surgical morbidity.  The primary endpoint is surgical morbidity/mortality up to 90 days (Clavien-Dindo and the Comprehensive Complication Index). Secondary endpoints include pathological quality assessment with completeness of mesocolon excision (CME) be assessed according to Benz classification and patient reported outcomes. An expanded RoLaCaRT-2 study with 320 patients is expected to commence in 2022 as follow on from this study.