Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Stony Brook University
Sponsor:
Information provided by (Responsible Party):
Roberto Bergamaschi, Stony Brook University
ClinicalTrials.gov Identifier:
NCT01702116
First received: August 11, 2011
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

This is a study that compares two types of surgery for rectal cancer. There are two procedures that can be used during this surgery, conventional abdominal resection (APR) and extended (or extralevator) APR. The investigators are doing this research to see whether the extralevator APR increases the likelihood that the edge of the tissue that is removed will be more likely to be free from cancer cells compared with the conventional APR surgery. At this time there is no evidence that one type of procedure is better at this than the other. The objective of this research is to determine whether extralevator APR is more likely to have clean margins (free of cancer) compared to the standard APR surgery.


Condition Intervention
Rectal Adenocarcinoma
Procedure: extralevator APR
Procedure: APR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • measurement of circumferential resection margin [ Time Frame: 0-10 minutes post surgery ] [ Designated as safety issue: No ]
    Measurement in millimeters (mm) of the circumferential resection margin.


Secondary Outcome Measures:
  • operative time [ Time Frame: 4-6 hours ] [ Designated as safety issue: No ]
    operative time from skin incision to skin closure

  • hospital stay [ Time Frame: from beginning of surgery through discharge, usually 4-5 days ] [ Designated as safety issue: No ]
    duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)

  • estimated blood loss [ Time Frame: 4-6 hours ] [ Designated as safety issue: No ]
    estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)


Estimated Enrollment: 34
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: extralevator APR
This is a modified and more extensive procedure that is used to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more "cylindrical" specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive.
Procedure: extralevator APR
Extralevator Abdominoperineal Resection For Rectal Adenocarcinoma. The aim of this modified and more extensive procedure is to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more "cylindrical" specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive.
Active Comparator: standard APR
conventional abdominoperineal resection (APR)
Procedure: APR
standard Abdominoperineal Resection For Rectal Adenocarcinoma

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resectable, histologically proven primary adenocarcinoma of the low rectum with internal and/or external sphincter muscle involvement. Staged as follows prior to neoadjuvant chemoradiation:
  • Stage T3 or T4 at MRI
  • N0-2 at MRI
  • M0 at CT scan
  • Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents

Exclusion Criteria:

  • Squamous cell carcinoma
  • Adenocarcinoma Stage T1-2, any N
  • T4 with one of the following:

with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed consent Pregnancy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702116

Contacts
Contact: Roberto Bergamaschi, MD, PhD 631-444-2704 rbergamaschi@notes.cc.sunysb.edu
Contact: Eileen Finnin, RN 631-444-5454 efinnin@notes.cc.sunysb.edu

Locations
United States, New York
State University Hospital Medical Center Recruiting
Stony Brook, New York, United States, 11794-8191
Contact: Roberto Bergamaschi, MD, PhD    631-444-2704    rbergamaschi@notes.cc.sunysb.edu   
Contact: Paula Denoya, MD    631-444-3431    pdenoya@notes.cc.sunysb.edu   
Sub-Investigator: Paula Denoya, MD         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Roberto Bergamaschi, MD, PhD    631-444-2704    rbergamaschi@notes.cc.sunysb.edu   
Principal Investigator: Roberto Bergamaschi, MD, PhD         
Sub-Investigator: Paula Denoya, MD         
Sub-Investigator: Sami Khan, MD         
Sub-Investigator: Meenakshi Singh, MD         
Sub-Investigator: Kenneth Shroyer, MD         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Roberto Bergamaschi, MD, PhD    631-444-2704    rbergamaschi@notes.cc.sunysb.edu   
Principal Investigator: Roberto Bergamaschi, MD, PhD         
Sub-Investigator: Paula Denoya, MD         
Sub-Investigator: Sami Khan, MD         
Sub-Investigator: Meenakshi Singh, MD         
Stony Broook University Medical Center Recruiting
Stony Brook, New York, United States, 11794-8191
Contact: Roberto Bergamaschi, MD, PhD    631-444-2704    rbergamaschi@notes.cc.sunysb.edu   
Contact: Paula Denoya, MD    631-444-3431    pdenoya@notes.cc.sunysb.edu   
Sub-Investigator: Paula Denoya, MD         
Sub-Investigator: Kenneth Shroyer, MD         
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Roberto Bergamaschi, MD, PhD Stony Brook University Medical Center
  More Information

No publications provided

Responsible Party: Roberto Bergamaschi, Professor and Chief, Colon and Rectal Surgery, Stony Brook University
ClinicalTrials.gov Identifier: NCT01702116     History of Changes
Other Study ID Numbers: APR2011
Study First Received: August 11, 2011
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
rectal adenocarcinoma
Standard APR
Extralevator APR

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014