Transanal Total Mesorectal Excision with Laparoscopic Assistance in Treating Patients with Rectal Cancer
Inclusion Criteria
- 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
Exclusion Criteria
- 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
California
Los Angeles
Orange
Florida
Orlando
Weston
Massachusetts
Burlington
Worcester
New York
New York
Ohio
Cleveland
Oregon
Medford
Pennsylvania
Wynnewood
Ontario
Toronto
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
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).
OUTLINE:
Patients undergo taTME with laparoscopic assistance.
After completion of study treatment, patients are followed up for up to 5 years.
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Icahn School of Medicine at Mount Sinai
Principal Investigator
Patricia Sylla
- Primary ID 16-2009
- Secondary IDs NCI-2017-01497
- Clinicaltrials.gov ID NCT03144765