Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Rectal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01702116
• Other study ID #: APR2011
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2011
• Last updated: April 23, 2013
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: April 2013
• Source: Stony Brook University
• Contact: Roberto Bergamaschi, MD, PhD
• Phone: 631-444-2704
• Email: rbergamaschi[@]notes.cc.sunysb.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Adenocarcinoma
• Rectal Neoplasms

Intervention

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.
• APR
standard Abdominoperineal Resection For Rectal Adenocarcinoma

Locations

Country	Name	City	State
United States	State University Hospital Medical Center	Stony Brook	New York
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Stony Broook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of circumferential resection margin	Measurement in millimeters (mm) of the circumferential resection margin.	0-10 minutes post surgery	No
Secondary	operative time	operative time from skin incision to skin closure	4-6 hours	No
Secondary	hospital stay	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	No
Secondary	estimated blood loss	estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)	4-6 hours	No