Multicenter Phase II Study of Transanal TME (taTME)

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · May 8, 2017

Keywords

ClinConnect Summary

This clinical trial is testing a new surgical method called transanal total mesorectal excision (taTME) for patients with rectal cancer. This technique aims to improve surgery outcomes by allowing doctors to access the rectum from below, which may help avoid some difficulties encountered with traditional methods. The study will involve around 100 participants who have been diagnosed with resectable rectal cancer and have specific criteria, such as having tumors that are not too advanced and having no other serious health issues.

Participants will undergo a surgery called low anterior resection (LAR) with the taTME method, potentially using robotic assistance. Throughout the study, researchers will monitor the safety and effectiveness of this approach, looking to see if it performs as well as standard surgical techniques. Eligible participants must be at least 18 years old and diagnosed with certain types of rectal cancer, while those with more advanced cancers or certain health problems may not qualify. It’s important to note that this trial is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

• 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