Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
1 other identifier
interventional
34
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2011
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 11, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedApril 25, 2013
April 1, 2013
2 years
August 11, 2011
April 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
measurement of circumferential resection margin
Measurement in millimeters (mm) of the circumferential resection margin.
0-10 minutes post surgery
Secondary Outcomes (3)
operative time
4-6 hours
hospital stay
from beginning of surgery through discharge, usually 4-5 days
estimated blood loss
4-6 hours
Study Arms (2)
extralevator APR
EXPERIMENTALThis 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.
standard APR
ACTIVE COMPARATORconventional abdominoperineal resection (APR)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
State University Hospital Medical Center
Stony Brook, New York, 11794-8191, United States
Stony Broook University Medical Center
Stony Brook, New York, 11794-8191, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Related Publications (1)
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.
PMID: 27369739DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto Bergamaschi, MD, PhD
Stony Brook University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chief, Colon and Rectal Surgery
Study Record Dates
First Submitted
August 11, 2011
First Posted
October 5, 2012
Study Start
July 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
April 25, 2013
Record last verified: 2013-04