COLOR III trial A multicentre randomised clinical trial comparing - - PowerPoint PPT Presentation
COLOR III trial A multicentre randomised clinical trial comparing Transanal TME versus Laparoscopic TME for mid and low rectal cancer COLOR III study group Amsterdam UMC, location VUmc Contact: prof HJ Bonj er principal invest igat or
Amsterdam UMC, location VUmc
prof HJ Bonj er principal invest igat or dr JB Tuynman t rial direct or S E van Oost endorp coordinat or
Contact: colortrial@ vumc.nl www.color3trial.com
CAT-tool S urgical Quality assessment
PRETRIAL
COLOR III summary | February 2019
Main inclusion criteria: solitary mid or distal rectal cancer (0-10cm; sagittal MRI) suitable for elective surgery curative intent Restorative intent (anastomosis either colorectal or coloanal) Main exclusion criteria: T4 (after neoadj uvant therapy) T3 with <1mm distance to MRF after neoadj uvant therapy Distant metastases Planned APE/ colostomy(hartmann)
* Robot assisted approach for abdominal phase allowed
COLOR III summary | February 2019
Non - inferiority trial TaTME : Laparoscopic TME Randomization 2:1 Primary endpoint = local recurrence at 3-years Estimated recurrence = 5% , difference < 4% N = 1104 patients
COLOR III summary | February 2019
ycT1-3N0-2 M0 MRI MRF > 1 mm Curative and restorative intent Eligibility Randomization Transanal TME Laparoscopic TME local recurrence at 3-years Pathology, Morbidity, HrQOL, DFS , OS
Pre-trial S QA completed
S econdary Primary outcome
MRI VIDEO MRI PHOTO
Central Review
COLOR III summary | February 2019
COLOR III summary | February 2019
COLOR III summary | February 2019
Center Local investigator City Country Hongkong University Chi-chung Foo Hongkong China National University Hospital Choon Seng Singapore Singapore National Cancer Center Goyang Sung Chan Park Goyang Korea Chinese university of HK
Hongkong China Royal Brisbane Hospital Stevenson Brisbane Australia Florida Hospital Monson Orlando USA Kantonsspital Brunner
Swiss Rotkreuzklinikum Thasler München Germany Asklepios Buia Langen Germany Uniklinik Jansen-Winkeln Leipzig Germany Johannes Gutenburg Kneist Mainz Germany Klinikum Rink Leverkusen Germany Universitätsklinikum Würzburg Kim Würzburg Germany Center Local investigator City Country Hospital Clínic
Barcelona Spain OLVG Gerhards Amsterdam Netherlands Zorgsaam Lagae Terneuzen Netherlands Agnelli Hospital Muratore Pinerolo Italy San Andrea Berti Spezia Italy Gemelli Persiani Rome Italy Gradenigo Borreca Turin Italy Limirick Coffey Limerick Ireland UHFJD C.Pastor Idolate Madrid Spain Hospital Clinico Universitario Moro Valdezate Valencia Spain
Miskovic London UK Yeovil District Hospital (YDH) Francis Yeovil UK UZ Gent Van Nieuwenhove Gent Belgium Jessah Knol Hasselt Belgium
COLOR III summary | December 2018