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 colortrial@ vumc.nl dr JB Tuynman t rial direct or www.color3trial.com S E van Oost endorp coordinat or
CAT-tool Continuous PRETRIAL Quality assurance S urgical Quality assessment COLOR III summary | February 2019
In- and exclusion criteria 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
Design 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 Pre-trial S QA MRI MRF > 1 mm Central completed Curative and restorative intent Review Eligibility MRI Randomization Transanal TME Laparoscopic TME VIDEO local recurrence at MRI Primary outcome 3-years Pathology, Morbidity, S econdary PHOTO HrQOL, DFS , OS COLOR III summary | February 2019
COLOR III summary | February 2019
Sites open for accrual COLOR III summary | February 2019
In process of joining Center Local investigator City Country Center Local investigator City Country Hospital Clínic A. Lacy Barcelona Spain Hongkong University Chi-chung Foo Hongkong China OLVG Gerhards Amsterdam Netherlands National University Hospital Choon Seng Singapore Singapore Zorgsaam Lagae Terneuzen Netherlands National Cancer Center Goyang Sung Chan Park Goyang Korea Muratore Agnelli Hospital Pinerolo Italy Chinese university of HK S. Ng Hongkong China San Andrea Berti Spezia Italy Royal Brisbane Hospital Stevenson Brisbane Australia Gemelli Persiani Rome Italy Florida Hospital Monson Orlando USA Gradenigo Borreca Turin Italy Kantonsspital Brunner St. gallen Swiss Limirick Coffey Limerick Ireland Rotkreuzklinikum Thasler München Germany UHFJD C.Pastor Idolate Madrid Spain Asklepios Buia Langen Germany Hospital Clinico Universitario Moro Valdezate Valencia Spain Uniklinik Jansen-Winkeln Leipzig Germany St. Marks Miskovic London UK Johannes Gutenburg Kneist Mainz Germany Yeovil District Hospital (YDH) Francis Yeovil UK UZ Gent Van Nieuwenhove Gent Belgium Rink Klinikum Leverkusen Germany Jessah Knol Hasselt Belgium Universitätsklinikum Würzburg Kim Würzburg Germany COLOR III summary | December 2018
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