Study ID: NCT03144765
Multicenter phase 2 study of transanal TME (taTME)
This surgical trial for patients diagnosed with resectable rectal cancer is studying the safety and efficacy of a new surgical procedure called low anterior resection with transanal total mesorectal excision (taTME). Transanal TME uses a “bottom-up approach” to overcome the technical difficulties of low pelvic dissection using an abdominal approach. Participants will undergo laparoscopic or robotic surgery.
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. The researchers seek to determine if taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.
- New diagnosis of histologically confirmed adenocarcinoma of the rectum
- 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
- Complete preoperative colonoscopy demonstrating no synchronous colon cancer
- 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
- Must have been newly diagnosed with resectable rectal cancer
- Must be willing to undergo laparoscopic or robotic surgical procedure
- Must not have a prior history of colorectal cancer or inflammatory bowel disease