Last updated on February 2020

Multicenter Phase II Study of Transanal TME (taTME)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Colon Cancer Screening | Surgery | Surgical aspects | Colorectal Cancer | Rectal Cancer | Colon cancer; rectal cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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