Transanal Total Mesorectal Excision with Laparoscopic Assistance in Treating Patients with Rectal Cancer
This phase II trial studies how well transanal mesorectal excision with laparoscopic assistance works in treating patients with rectal cancer. Transanal mesorectal excision with laparoscopic assistance is a procedure that combines standard laparoscopy, or multiple small abdominal incisions, with surgery through the anus in order to remove rectal cancer, and it may work better in treating patients with rectal cancer.
- New diagnosis of histologically confirmed adenocarcinoma of the rectum
- Rectal cancer originally staged as T1, T2, or T3, node negative (N0) or node positive (N1, N2) by pelvic magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Circumferential radial margin not involved with tumor on pelvic MRI
- No evidence of metastasis on staging computed tomography (CT) or positron emission tomography (PET) 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
- Participants must be eligible to undergo laparoscopic or robotic low anterior resection with or without a temporary diverting stoma, based on multidisciplinary tumor board consensus
- Ability to understand and the willingness to sign a written informed consent document
- Rectal cancer staged as T4 by pelvic MRI
- Participants with preoperatively staged T3, N1, or N2 tumors who return > 12 weeks following completion of neoadjuvant chemoradiation therapy (CRT)
- Severely symptomatic rectal tumors (near-completely obstructing, symptomatic bleeding)
- 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 including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with chemotherapy and/or radiation
- Subjects who cannot read or understand English
Locations & Contacts
Contact: Karen N. Zaghiyan
Contact: Elisabeth Christine McLemore
Contact: Alessio Pigazzi
Contact: Matthew Albert
Contact: Dana Sands
Contact: Peter W Marcello
Contact: Justin A. Maykel
Contact: Antoinette M Bonaccorso
Contact: Patricia Sylla
Contact: Scott Russell Steele
Contact: Mark H. Whiteford
Contact: John H. Marks
Contact: Sami A Chadi
Trial Objectives and Outline
I. To determine the efficacy of transanal (ta) total mesorectal excision (TME) as defined by pathological assessment of complete and near-complete mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.
I. To perform complete pathologic assessment of the surgical specimen.
II. To determine the incidence of 30-day perioperative complications including intraoperative and postoperative complications.
III. Long-term (> 30 days) complications.
IV. Changes in functional results (bowel function, urinary function, and sexual function).
V. Assess 3-year oncologic outcomes (recurrence and survival).
Patients undergo taTME with laparoscopic assistance.
After completion of study treatment, patients are followed up for up to 5 years.
Trial Phase & Type
Icahn School of Medicine at Mount Sinai
Secondary IDs NCI-2017-01497
Clinicaltrials.gov ID NCT03144765