Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
Status unconfirmed · Not applicable
Conditions studied: Rectal Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT01702116
- Run by
- Stony Brook University
- People needed
- 34
- Starts
- 2011-07-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2013-04-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- State University Hospital Medical Center — Stony Brook, New York, United States (enrolling)
- Stony Broook University Medical Center — Stony Brook, New York, United States (enrolling)
- Stony Brook University Medical Center — Stony Brook, New York, United States (enrolling)
- Stony Brook University Medical Center — Stony Brook, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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