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


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Adenocarcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

measurement of circumferential resection margin

Outcome Description:

Measurement in millimeters (mm) of the circumferential resection margin.

Outcome Time Frame:

0-10 minutes post surgery

Safety Issue:

No

Principal Investigator

Roberto Bergamaschi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stony Brook University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

APR2011

NCT ID:

NCT01702116

Start Date:

July 2011

Completion Date:

July 2013

Related Keywords:

  • Rectal Adenocarcinoma
  • rectal adenocarcinoma
  • Standard APR
  • Extralevator APR
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms

Name

Location

Stony Brook University Medical CenterStony Brook, New York  11794
State University Hospital Medical CenterStony Brook, New York  11794-8191
Stony Broook University Medical CenterStony Brook, New York  11794-8191