Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

April 23, 2013 updated by: Roberto Bergamaschi, Stony Brook University

Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
        • Sub-Investigator:
          • Paula Denoya, MD
        • Principal Investigator:
          • Roberto Bergamaschi, MD, PhD
        • Sub-Investigator:
          • Sami Khan, MD
        • Sub-Investigator:
          • Meenakshi Singh, MD
      • Stony Brook, New York, United States, 11794-8191
      • Stony Brook, New York, United States, 11794-8191
        • Recruiting
        • Stony Broook University Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Paula Denoya, MD
        • Sub-Investigator:
          • Kenneth Shroyer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of circumferential resection margin
Time Frame: 0-10 minutes post surgery
Measurement in millimeters (mm) of the circumferential resection margin.
0-10 minutes post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 4-6 hours
operative time from skin incision to skin closure
4-6 hours
hospital stay
Time Frame: from beginning of surgery through discharge, usually 4-5 days
duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)
from beginning of surgery through discharge, usually 4-5 days
estimated blood loss
Time Frame: 4-6 hours
estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)
4-6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Roberto Bergamaschi, MD, PhD, Stony Brook University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

August 11, 2011

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APR2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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