Clinical Trial of the Week: Interventional trial for patients diagnosed with resectable rectal cancer

By Donna Loyle, communications specialist, LIMR

March is Colorectal Cancer Awareness Month, which makes this a great time to highlight the taTME clinical trial available at Lankenau Medical Center.

This five-year, phase II, multicenter, single-arm surgical trial is for patients diagnosed with resectable rectal cancer. Researchers are studying the safety and efficacy of a surgical procedure called low anterior resection (LAR) 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 undergo laparoscopic or robotic surgery. The researchers seek to determine if taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.

The study is based on the TATA procedure that was developed and first performed by the team of John H Marks, MD, chief of colorectal surgery and director of minimally invasive colorectal surgery and rectal cancer management fellowship program at Main Line Health. Dr. Marks is serving as Main Line Health’s principal investigator for the study.

The taTME procedure combines standard laparoscopy, or multiple small abdominal incisions, with surgery through the anus to remove cancerous tissue of the rectum. An alternative to standard abdominal surgery, taTME overcomes many challenges related to deep pelvic surgeries.

Inclusion criteria for this surgical trial:

  • No prior history of colorectal cancer or inflammatory bowel disease
  • 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

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