Clinical trial NCT01702116: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Adenocarcinoma
Keywords: rectal adenocarcinoma
Standard APR
Extralevator APR
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: measurement of circumferential resection margin
timeFrame: 0-10 minutes post surgery
Secondary outcomes:
measure: operative time
timeFrame: 4-6 hours
measure: hospital stay
timeFrame: from beginning of surgery through discharge, usually 4-5 days
measure: estimated blood loss
timeFrame: 4-6 hours
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: State University Hospital Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Broook University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
Study officials:
affiliation: Stony Brook University Medical Center
name: Roberto Bergamaschi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.