Recruiting

Extralevator vs. Standard

Sponsor:

Stony Brook University

Code:

NCT01702116

Conditions

Rectal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

extralevator APR

APR

Study Details

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.

Conditions

Rectal Adenocarcinoma

Study ID

NCT01702116

Start date

Jul, 2011

Status verified date

Apr, 2013

Completion date

Jul, 2013

Anticipated

Primary completion date

Jul, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: standard APR

conventional abdominoperineal resection (APR)

Interventions

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.

APR

standard Abdominoperineal Resection For Rectal Adenocarcinoma

Primary outcome measure

  • measurement of circumferential resection margin [ Time Frame: 0-10 minutes post surgery ]

Central Contacts and Locations

Central contacts

Roberto Bergamaschi, MD, PhD

631-444-2704rbergamaschi@notes.cc.sunysb.edu

Eileen Finnin, RN

631-444-5454efinnin@notes.cc.sunysb.edu

Locations

State University Hospital Medical Center

Recruiting

Stony Brook, New York, United States, 11794-8191

Contacts

Roberto Bergamaschi, MD, PhD

631-444-2704rbergamaschi@notes.cc.sunysb.edu

Paula Denoya, MD

631-444-3431pdenoya@notes.cc.sunysb.edu

Stony Broook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794-8191

Contacts

Roberto Bergamaschi, MD, PhD

631-444-2704rbergamaschi@notes.cc.sunysb.edu

Paula Denoya, MD

631-444-3431pdenoya@notes.cc.sunysb.edu

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Roberto Bergamaschi, MD, PhD

631-444-2704rbergamaschi@notes.cc.sunysb.edu

Principal Investigator:

Roberto Bergamaschi, MD, PhD

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Roberto Bergamaschi, MD, PhD

631-444-2704rbergamaschi@notes.cc.sunysb.edu

Principal Investigator:

Roberto Bergamaschi, MD, PhD

More Information

Sponsor

Stony Brook University

Last update posted

Apr 25, 2013

Last verified

Apr, 2013

Keywords

  • rectal adenocarcinoma
  • Standard APR
  • Extralevator APR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2013-04-25.