Multicenter Phase II Study of Transanal TME (taTME) (NCT03144765) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Multicenter Phase II Study of Transanal TME (taTME)
United States, Canada100 participantsStarted 2017-09-25
Plain-language summary
Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation treatment (CRT), complete TME with negative resection margins is associated with sustained local and systemic control even in locally advanced disease. Over the last 2 decades, laparoscopic and robotic techniques have been increasingly adopted due to reduced surgical trauma and faster patient recovery. Yet, both approaches are associated with equivalent postoperative morbidity and disturbances in sexual, urinary and defecatory function relative to open TME. Furthermore, laparoscopic and robotic TME remain associated with substantial conversion rates and variable rates of TME completeness as a result of the procedural difficulties reaching the low rectum from the abdominal approach. Transanal TME (taTME) with laparoscopic assistance was developed to facilitate completion of TME using a primary transanal endoscopic approach. Transanal TME uses a "bottom-up approach" to overcome the technical difficulties of low pelvic dissection using an abdominal approach. Published results from single-center taTME series and an international registry suggest the short-term procedural and oncologic safety of this approach in resectable rectal cancer. No multicenter phase II study has yet been conducted to validate the procedural safety, functional outcomes or long-term oncologic outcomes of this approach.
Study Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic assistance in 100 eligible subjects with resectable rectal cancer.
Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* New diagnosis of histologically confirmed adenocarcinoma of the rectum
* Age ≥18
* Clinical stage cT1 (high-risk), T2, or T3, cN0, N1, N2 on staging pelvic MRI
* Negative predicted CRM on staging pelvic MRI
* No evidence of metastasis on CT scans of the chest, abdomen and pelvis
* Rectal cancer located within 10 cm from the anal verge based on proctoscopy and digital rectal examination (DRE)
* Complete preoperative colonoscopy demonstrating no synchronous colon cancer
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
* Eligible to undergo laparoscopic or robotic LAR with or without a temporary diverting stoma, based on multidisciplinary tumor board consensus
* Able to understand and willing to sign a written informed consent form
Exclusion Criteria:
* cT4 on staging pelvic MRI
* \>12 weeks delay between completion of neoadjuvant CRT and planned study procedure
* Severely symptomatic rectal tumors
* Tumors invading into the internal anal sphincter muscle based on DRE and pelvic MRI
* Fecal incontinence at baseline
* Prior history of rectal resection
* Prior history of colorectal cancer
* History of inflammatory bowel disease
* Uncontrolled concurrent illness
* Pregnancy
* Subjects who cannot read or understand English
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.