Transanal Total Mesorectal Excision with Laparoscopic Assistance in Treating Patients with Rectal Cancer

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

California

Los Angeles
Cedars Sinai Medical Center
Status: Active
Contact: Karen N. Zaghiyan
Phone: 310-289-9224
Email: kzaghiyan@yahoo.com
Kaiser Permanente Los Angeles Medical Center
Status: Active
Contact: Elisabeth Christine McLemore
Phone: 323-783-6848
Email: Elisabeth.C.Mclemore@kp.org
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Alessio Pigazzi
Phone: 714-456-6924
Email: apigazzi@uci.edu

Florida

Orlando
AdventHealth Orlando
Status: Active
Contact: Matthew Albert
Phone: 407-303-2615
Email: Matthew.Albert.MD@flhosp.org
Weston
Cleveland Clinic-Weston
Status: Active
Contact: Dana Sands
Phone: 954-659-5251
Email: sandsd@ccf.org

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Peter W Marcello
Phone: 781-744-3706
Email: peter.w.marcello@lahey.org
Worcester
University of Massachusetts Medical School
Status: Active
Contact: Justin A. Maykel
Phone: 508-334-8195
Email: Justin.Maykel@umassmemorial.org

New York

New York
Icahn School of Medicine at Mount Sinai
Status: Active
Contact: Antoinette M Bonaccorso
Phone: 212-241-2065
Email: Antoinette.bonaccorso@mountsinai.org
Mount Sinai Union Square
Status: Active
Contact: Patricia Sylla
Phone: 212-241-2895
Email: patricia.sylla@mountsinai.org

Ohio

Cleveland
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Status: Active
Contact: Scott Russell Steele
Phone: 216-444-4715
Email: Steeles3@ccf.org

Oregon

Medford
Providence Cancer Center
Status: Active
Contact: Mark H. Whiteford
Phone: 503-963-2866
Email: mwhiteford@orclinic.com

Pennsylvania

Wynnewood
Lankenau Medical Center
Status: Active
Contact: John H. Marks
Phone: 610-645-9093
Email: MarksJ@Mlhs.org

Ontario

Toronto
Toronto Western Hospital
Status: Active
Contact: Sami A Chadi
Email: sami.chadi@uhn.ca

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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 & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Icahn School of Medicine at Mount Sinai

Principal Investigator
Patricia Sylla

Trial IDs

Primary ID 16-2009
Secondary IDs NCI-2017-01497
Clinicaltrials.gov ID NCT03144765