Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

COLOR III Trial: Transanal vs Laparoscopic TME (COLORIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736942
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2016
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
H.J. Bonjer, VU University Medical Center

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.


Condition or disease Intervention/treatment Phase
Rectal Carcinoma Surgery Procedure: Laparoscopic TME Procedure: TaTME Phase 3

Detailed Description:

To improve oncological and functional outcomes of patients with rectal cancer new surgical techniques are being developed. The adoption of the TME technique has resulted in better oncological outcome in the last decades. The addition of neoadjuvant therapy has further improved oncological outcome. The minimal invasive laparoscopic resection of rectal cancer has shown to be safe and to result in improved short-term outcomes and reduced morbidity.

Nevertheless, the laparoscopic resection of mid and low rectal cancer remains challenging due to the anatomy of the narrow pelvis and is associated with a relative high risk of resections with an involved CRM resulting in increased risk of a local recurrence.

In attempt to improve the quality of the TME procedure in low rectal cancer and further improve oncological results the TaTME has been developed, in which the rectum is dissected transanally according to TME principles. First series have been described since 2010 and although randomised evidence is still lacking this new technique has shown to be feasible and safe. The rectum including the total mesorectum is mobilised transanally in a reversed way with minimally invasive surgery including high quality imaging techniques.

The TaTME technique for mid and low rectal cancer has shown to have potential benefits: better specimen quality with less R1 resections, less morbidity, less conversion to laparotomy and more sphincter saving rectal resections without compromising oncological outcomes.

The investigators propose to evaluate the TaTME technique compared with conventional laparoscopic rectal resection for patients with mid and low rectal cancer in an international randomised trial: the COLOR III trial.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COLOR III: A Multicentre Randomised Clinical Trial Comparing Transanal TME Versus Laparoscopic TME for Mid and Low Rectal Cancer
Actual Study Start Date : December 2, 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2025

Arm Intervention/treatment
Active Comparator: Laparoscopic
Laparoscopic TME
Procedure: Laparoscopic TME
Laparoscopic Total Mesorectal Excision

Experimental: Transanal
TaTME
Procedure: TaTME
Transanal Total Mesorectal Excision




Primary Outcome Measures :
  1. Local recurrence rate [ Time Frame: 3 years ]
    Local recurrence rate, determined by MRI at 3 year follow-up


Secondary Outcome Measures :
  1. Percentage of participants with involvement of circumferential resection margin (tumour cells < 1mm from circumferential resection margin) [ Time Frame: Post operative 1 month ]
    Pathological microscopic examination of specimen

  2. Morbidity rate [ Time Frame: 5 years ]
  3. Mortality rate [ Time Frame: 5 years ]
  4. Percentage of participants with recurrence [ Time Frame: 5 years ]
    Local and distant.

  5. Disease-free survival rate [ Time Frame: 5 years ]
  6. Overall survival rate [ Time Frame: 5 years ]
  7. Percentage of sphincter saving procedures [ Time Frame: 4 years ]
  8. Change in functional outcomes (LARS questionnaire) [ Time Frame: Baseline and 1 year ]
    Measured by questionnaires

  9. Change in Health Related Quality of Life (EORTC QLQ-29 questionnaire) [ Time Frame: Baseline and 1 year ]
    Measured by questionnaires

  10. Change in Health Related Quality of Life (EORTC QLQ-30 questionnaire) [ Time Frame: Baseline and 1 year ]
    Measured by questionnaires

  11. Change in Health Related Quality of Life (EQ 5-D questionnaire) [ Time Frame: Baseline and 1 year ]
    Measured by questionnaires



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736942


Locations
Layout table for location information
Netherlands
VU University Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
VU University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Hendrik J. Bonjer, MD, PhD VU University Medical Center
Principal Investigator: Antonio M. Lacy, MD, PhD Hospital Clinic of Barcelona
Principal Investigator: George B. Hanna, MD, PhD Imperial College London
Study Director: Jurriaan B. Tuynman, MD, PhD VU University Medical Center
Study Director: Colin Sietses, MD, PhD Gelderse Vallei Hospital Ede

Additional Information:
Layout table for additonal information
Responsible Party: H.J. Bonjer, Professor of Surgery, MD, PhD, FRCSC, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02736942     History of Changes
Other Study ID Numbers: 2015.449
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are not sharing confidential individual patient data.