COLOR III Trial: Transanal vs Laparoscopic TME (COLORIII)
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|ClinicalTrials.gov Identifier: NCT02736942|
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2016
Last Update Posted : June 6, 2019
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Laparoscopic
Procedure: Laparoscopic TME
Laparoscopic Total Mesorectal Excision
Transanal Total Mesorectal Excision
- Local recurrence rate [ Time Frame: 3 years ]Local recurrence rate, determined by MRI at 3 year follow-up
- 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
- Morbidity rate [ Time Frame: 5 years ]
- Mortality rate [ Time Frame: 5 years ]
- Percentage of participants with recurrence [ Time Frame: 5 years ]Local and distant.
- Disease-free survival rate [ Time Frame: 5 years ]
- Overall survival rate [ Time Frame: 5 years ]
- Percentage of sphincter saving procedures [ Time Frame: 4 years ]
- Change in functional outcomes (LARS questionnaire) [ Time Frame: Baseline and 1 year ]Measured by questionnaires
- Change in Health Related Quality of Life (EORTC QLQ-29 questionnaire) [ Time Frame: Baseline and 1 year ]Measured by questionnaires
- Change in Health Related Quality of Life (EORTC QLQ-30 questionnaire) [ Time Frame: Baseline and 1 year ]Measured by questionnaires
- Change in Health Related Quality of Life (EQ 5-D questionnaire) [ Time Frame: Baseline and 1 year ]Measured by questionnaires
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
|VU University Medical Center|
|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|