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Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Primary Purpose

Rectal Adenocarcinoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
extralevator APR
APR
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Adenocarcinoma focused on measuring rectal adenocarcinoma, Standard APR, Extralevator APR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State University Hospital Medical CenterRecruiting
  • Stony Broook University Medical CenterRecruiting
  • Stony Brook University Medical CenterRecruiting
  • Stony Brook University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

extralevator APR

standard APR

Arm Description

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.

conventional abdominoperineal resection (APR)

Outcomes

Primary Outcome Measures

measurement of circumferential resection margin
Measurement in millimeters (mm) of the circumferential resection margin.

Secondary Outcome Measures

operative time
operative time from skin incision to skin closure
hospital stay
duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)
estimated blood loss
estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)

Full Information

First Posted
August 11, 2011
Last Updated
April 23, 2013
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT01702116
Brief Title
Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
Official Title
Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Adenocarcinoma
Keywords
rectal adenocarcinoma, Standard APR, Extralevator APR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
extralevator APR
Arm Type
Experimental
Arm Description
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.
Arm Title
standard APR
Arm Type
Active Comparator
Arm Description
conventional abdominoperineal resection (APR)
Intervention Type
Procedure
Intervention Name(s)
extralevator APR
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
APR
Intervention Description
standard Abdominoperineal Resection For Rectal Adenocarcinoma
Primary Outcome Measure Information:
Title
measurement of circumferential resection margin
Description
Measurement in millimeters (mm) of the circumferential resection margin.
Time Frame
0-10 minutes post surgery
Secondary Outcome Measure Information:
Title
operative time
Description
operative time from skin incision to skin closure
Time Frame
4-6 hours
Title
hospital stay
Description
duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)
Time Frame
from beginning of surgery through discharge, usually 4-5 days
Title
estimated blood loss
Description
estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)
Time Frame
4-6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Bergamaschi, MD, PhD
Phone
631-444-2704
Email
rbergamaschi@notes.cc.sunysb.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Finnin, RN
Phone
631-444-5454
Email
efinnin@notes.cc.sunysb.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Bergamaschi, MD, PhD
Organizational Affiliation
Stony Brook University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University Hospital Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8191
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Bergamaschi, MD, PhD
Phone
631-444-2704
Email
rbergamaschi@notes.cc.sunysb.edu
First Name & Middle Initial & Last Name & Degree
Paula Denoya, MD
Phone
631-444-3431
Email
pdenoya@notes.cc.sunysb.edu
First Name & Middle Initial & Last Name & Degree
Paula Denoya, MD
Facility Name
Stony Broook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8191
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Bergamaschi, MD, PhD
Phone
631-444-2704
Email
rbergamaschi@notes.cc.sunysb.edu
First Name & Middle Initial & Last Name & Degree
Paula Denoya, MD
Phone
631-444-3431
Email
pdenoya@notes.cc.sunysb.edu
First Name & Middle Initial & Last Name & Degree
Paula Denoya, MD
First Name & Middle Initial & Last Name & Degree
Kenneth Shroyer, MD
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Bergamaschi, MD, PhD
Phone
631-444-2704
Email
rbergamaschi@notes.cc.sunysb.edu
First Name & Middle Initial & Last Name & Degree
Roberto Bergamaschi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Paula Denoya, MD
First Name & Middle Initial & Last Name & Degree
Sami Khan, MD
First Name & Middle Initial & Last Name & Degree
Meenakshi Singh, MD
First Name & Middle Initial & Last Name & Degree
Kenneth Shroyer, MD
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Bergamaschi, MD, PhD
Phone
631-444-2704
Email
rbergamaschi@notes.cc.sunysb.edu
First Name & Middle Initial & Last Name & Degree
Roberto Bergamaschi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Paula Denoya, MD
First Name & Middle Initial & Last Name & Degree
Sami Khan, MD
First Name & Middle Initial & Last Name & Degree
Meenakshi Singh, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
27369739
Citation
Bianco F, Romano G, Tsarkov P, Stanojevic G, Shroyer K, Giuratrabocchetta S, Bergamaschi R; International Rectal Cancer Study Group. Extralevator with vs nonextralevator abdominoperineal excision for rectal cancer: the RELAPe randomized controlled trial. Colorectal Dis. 2017 Feb;19(2):148-157. doi: 10.1111/codi.13436.
Results Reference
derived

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Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

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