COLOR III Trial: Transanal vs Laparoscopic TME

NCT02736942 | Unknown Phase 3 DMC

• 1 other identifier: 2015.449
• Study Type: interventional
• Target: 1,104
• Locations: 1 country
• Sites: 1

Brief Summary

Background Surgery for mid and low rectal cancer is associated with relative high rates of incomplete mesorectal excisions and high rates of circumferential resection margin (CRM) involvement resulting in significant number of local recurrences. Moreover, patients with mid and low rectal cancer suffer from high rates of morbidity, permanent colostomies and impairment of quality of life. The transanal TME (TaTME) has been developed to improve the quality of TME surgery in mid and low rectal cancer. Study design The COLOR III trial is an international multicentre randomised study comparing short- and long-term outcomes of TaTME and laparoscopic TME for rectal cancer. The study will include a quality assessment phase before randomisation to ensure required competency level and uniformity of the new TaTME technique and the laparoscopic TME. During the trial clinical data will be reviewed centrally to ensure uniform quality. Endpoints The primary endpoint of the study is the local recurrence rate at 3-years follow-up. 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. Statistics In laparoscopic TME the percentage of local recurrence at 3-years follow-up is estimated 5%. With the non-inferiority margin set at 4%, with a one-sided level of significance of 2.5% and a power of 80%, a total of 1104 patients is needed, 669 patients in the TaTME arm and 335 patients in the laparoscopic TME arm. All analyses will be performed on intention-to-treat basis. Main selection criteria 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. Hypothesis The hypothesis is that TaTME will result in a comparable local recurrence rate at 3-years follow-up with benefit of lower morbidity and conversions. Furthermore, because of direct endoscopic visualization, even in very low tumors a coloanal anastomosis can be created, resulting in a lower colostomy rate compared with laparoscopic and open resection. Because long-term outcomes are unknown, within a trial setting the technique can be standardized and quality control can be performed.

Conditions

Rectal Carcinoma; Surgery

Outcome Measures

Primary Outcomes (1)

• Local recurrence rate

  Local recurrence rate, determined by MRI at 3 year follow-up

  3 years

Secondary Outcomes (11)

• Percentage of participants with involvement of circumferential resection margin (tumour cells < 1mm from circumferential resection margin)

  Post operative 1 month

• Morbidity rate

  5 years

• Mortality rate

  5 years

• Percentage of participants with recurrence

  5 years

• Disease-free survival rate

  5 years

Study Arms (2)

Laparoscopic

ACTIVE COMPARATOR

Laparoscopic TME

Procedure: Laparoscopic TME

Transanal

EXPERIMENTAL

TaTME

Procedure: TaTME

Interventions

Laparoscopic TME PROCEDURE

Laparoscopic Total Mesorectal Excision

Laparoscopic

TaTME PROCEDURE

Transanal Total Mesorectal Excision

Transanal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Solitary mid (5.1-10cm from anal verge on MRI) or low (0-5cm from anal verge on MRI) rectal cancer observed at colonoscopy and histologically proven through biopsy
• Distal border of the tumour within 10cm from the anal verge on MRI-scan
• Tumour with threatened margins downstaged after neoadjuvant therapy to free margins
• No evidence for distal metastases on imaging of thorax and abdomen
• Suitable for elective surgical resection
• Informed consent according to local requirements

You may not qualify if:

• T3 tumours with margins less than 1mm to the MRF, determined by MRI-scan (as staged after preoperative chemo- and/or radiotherapy)
• T4 tumours, as staged after preoperative chemo- and/or radiotherapy
• Tumours with in growth more than 1/3 of anal sphincter complex or levator ani
• Malignancy other than adenocarcinoma at histological examination
• Patients under 18 years of age
• Pregnancy
• Previous rectal surgery (excluding local excision, EMR (endoscopic mucosal resection) or polypectomy)
• Signs of acute intestinal obstruction
• Multiple colorectal tumours
• Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative colitis
• Planned synchronous abdominal organ resections
• Preoperative suspicion of invasion of adjacent organs through MRI-scan
• Preoperative evidence for distant metastases through imaging of the thorax and abdomen
• Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
• Absolute contraindications to general anaesthesia or prolonged pneumoperitoneum, as severe cardiovascular or respiratory disease (ASA class \> III)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University Medical Center

Amsterdam, Netherlands

Location

Related Links

• Official trial website

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hendrik J. Bonjer, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Antonio M. Lacy, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• George B. Hanna, MD, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Jurriaan B. Tuynman, MD, PhD

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

• Colin Sietses, MD, PhD

  Gelderse Vallei Hospital Ede

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, MD, PhD, FRCSC

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: April 13, 2016
• Study Start: December 2, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2025
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)