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.


 

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