Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2011 |
| End Date: | July 2013 |
| Contact: | Roberto Bergamaschi, MD, PhD |
| Email: | rbergamaschi@notes.cc.sunysb.edu |
| Phone: | 631-444-2704 |
Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma
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.
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.
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
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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