Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) With Laparoscopic Assistance for Rectal Cancer

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic assistance in 100 eligible subjects with resectable rectal cancer. Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
California
Cedars Sinai Medical Center
Recruiting
Los Angeles
Kaiser Permanente
Recruiting
Los Angeles
UC Irvine Hospital
Recruiting
Orange
Florida
Florida Hospital
Recruiting
Orlando
Cleveland Clinic Florida
Recruiting
Weston
Massachusetts
Lahey Clinic
Recruiting
Burlington
University of Massachusetts
Recruiting
Worcester
New York
Icahn School of Medicine at Mount Sinai
Recruiting
New York
Mount Sinai Beth Israel
Recruiting
New York
Ohio
Cleveland Clinic
Recruiting
Cleveland
Oregon
Providence Portland Medical Center
Recruiting
Portland
Pennsylvania
Lankenau Institute
Recruiting
Wynnewood
Other Locations
Canada
Toronto Western Hospital
Recruiting
Toronto
Contact Information
Primary
Patricia Sylla, MD
ustametrial@mountsinai.org
212-241-7943
Backup
Antoinette Bonaccorso, MD
ustametrial@mountsinai.org
212-241-2065
Time Frame
Start Date: April 21, 2017
Estimated Completion Date: December 2024
Participants
Target number of participants: 100
Treatments
Experimental: taTME
Enrolled subjects will undergo the study procedure, laparoscopically-assisted Transanal Total Mesorectal Excision (taTME).
Related Therapeutic Areas
Sponsors
Collaborators: Research Foundation of the American Society of Colon and Rectal Surgeons, Society of American Gastrointestinal and Endoscopic Surgeons
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov

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