Name of the study
A MULTICENTRE RANDOMISED CLINICAL TRIAL COMPARING TRANSANAL TME VERSUS LAPAROSCOPIC TME FOR MID AND LOW RECTAL CANCER
Researchers and contact information
Professor dr. H.J. Bonjer
Dr. J.B. Tuynman
Other principal investigators
Prof. dr. G.B. Hanna
Imperial College London
Prof. dr. A.M. Lacy.
Professor dr. W.A. Bemelman
Amsterdam UMC locatie AMC
Dr. C. Sietses
Ziekenhuis Gelderse Vallei
Dr. R. Hompes
Amsterdam UMC locatie AMC
Prof. Dr. J.W.R. Twisk
Head dept of epidemiology and biostatistics, Amsterdam UMC location VUmc
Drs. SE. (Stefan) van Oostendorp
Amsterdam UMC locatie VUmc
Afdeling Heelkunde, Kamer 7F 20
De Boelelaan 1117, 1081 HV Amsterdam
Tel: +31 20 4443529
The quality of rectal cancer surgery has improved during the last decades with the total mesorectal excision (TME) technique, adaptation of laparoscopic surgery and extralevatory approach for abdominoperineal resection (APR). Nevertheless, surgery for mid and low rectal cancer is associated with relative high rates of conversions, permanent colostomies, and incomplete mesorectal excisions and relative high rates of circumferential resection margin (CRM) involvement resulting in significant number of local recurrences.
The transanal TME (TaTME) has been developed with use of laparoscopic single port platforms to improve the quality of the TME procedure in mid and low rectal cancer. In TaTME, the tumour is distally approached through the anus with laparoscopic instruments. In TaTME, the tumour is distally approached through the anus with laparoscopic instruments. Latest systematic review of cohort studies showed that the TaTME technique is feasible and facilitates difficult resections in the lower pelvis. A low conversion rate and more sphincter saving procedures are reported. Moreover the current data from cohort studies have shown that the TaTME procedure is safe and is associated with less conversions and less morbidity in experienced centers compared with laparoscopic TME.
Before adaptation of the TaTME as standard surgical therapy for mid an low rectal cancer, a well-designed study is essential to demonstrate its efficacy and safety in a multicenter randomized setting. The primary concern is oncological safety in terms of local recurrence rate. Secondary concerns are conversion rate, permanent colostomy rate and safety in terms of pathology, morbidity and functional outcome.
The COLOR III trial is an international multicenter randomized study comparing short- and long term outcomes of TaTME and laparoscopic TME for rectal cancer. The design is non-inferiority compared to conventional laparoscopic surgery. The study will include a quality assessment phase before entering the randomization-phase to ensure required competency level and uniformity of the new TaTME technique and the laparoscopic TME. During the trial the clinical data will be reviewed centrally to ensure uniform quality.
Patients with histologically proven single mid or distal rectum carcinoma (0 to 10 cm from anal verge) at MRI, eligible for restorative surgery with a curative intent, are included. Patients with a T1 tumor suitable for local excision, T3 tumors with a suspected involved circumferential resection margin and T4 tumors are excluded.
Local recurrence on MRI at 3 years follow-up after TME
Secondary endpoints include sphincter saving procedures, short-term morbidity and mortality, involved circumferential resection margin (CRM), disease-free and overall survival at 3 and 5 years, completeness of mesorectum and quality of life.
1104 patients in total; 669 in the TaTME arm and 335 in the laparoscopic TME arm to demonstrate a comparable local recurrence (LR) rate at 3-years follow-up. Expected LR rate is 5% in the control group, non-inferiority margin of 4% with a power 80% with a one-sided level of significance of 2.5%)
Laparoscopic abdominal TME resection
Transanal TME resection
Participating centers (Nederland)
Amsterdam UMC, locatie VUmc, dr JB Tuynman
Amsterdam UMC locatie AMC, prof WA Bemelman, dr PJ Tanis, dr R Hompes
Ziekenhuis Gelderse Vallei, dr C Sietses
Spaarne Gasthuis, dr HBAC Stockmann, Dr SJ Oosterling, dr. R Vuylsteke
IJsselland ziekenhuis, Dr EJ de Graaf, dr PG Doornebosch
Deventer ziekenhuis, Dr K Talsma, Dr. R Bosker
Nog niet open:
OLVG Amsterda, dr MF Gerhards
Zorgsaam Zeeuws-Vlaanderen, dr EAL Lagae
For a full list of all participating centers globally, please visit www.color3trial.com