<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01702116</url>
  </required_header>
  <id_info>
    <org_study_id>APR2011</org_study_id>
    <nct_id>NCT01702116</nct_id>
  </id_info>
  <brief_title>Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma</brief_title>
  <official_title>Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study that compares two types of surgery for rectal cancer. There are two&#xD;
      procedures that can be used during this surgery, conventional abdominal resection (APR) and&#xD;
      extended (or extralevator) APR. The investigators are doing this research to see whether the&#xD;
      extralevator APR increases the likelihood that the edge of the tissue that is removed will be&#xD;
      more likely to be free from cancer cells compared with the conventional APR surgery. At this&#xD;
      time there is no evidence that one type of procedure is better at this than the other. The&#xD;
      objective of this research is to determine whether extralevator APR is more likely to have&#xD;
      clean margins (free of cancer) compared to the standard APR surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measurement of circumferential resection margin</measure>
    <time_frame>0-10 minutes post surgery</time_frame>
    <description>Measurement in millimeters (mm) of the circumferential resection margin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operative time</measure>
    <time_frame>4-6 hours</time_frame>
    <description>operative time from skin incision to skin closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>from beginning of surgery through discharge, usually 4-5 days</time_frame>
    <description>duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated blood loss</measure>
    <time_frame>4-6 hours</time_frame>
    <description>estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Rectal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>extralevator APR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This 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 &quot;cylindrical&quot; specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard APR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional abdominoperineal resection (APR)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>extralevator APR</intervention_name>
    <description>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 &quot;cylindrical&quot; specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive.</description>
    <arm_group_label>extralevator APR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>APR</intervention_name>
    <description>standard Abdominoperineal Resection For Rectal Adenocarcinoma</description>
    <arm_group_label>standard APR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resectable, histologically proven primary adenocarcinoma of the low rectum with&#xD;
             internal and/or external sphincter muscle involvement. Staged as follows prior to&#xD;
             neoadjuvant chemoradiation:&#xD;
&#xD;
          -  Stage T3 or T4 at MRI&#xD;
&#xD;
          -  N0-2 at MRI&#xD;
&#xD;
          -  M0 at CT scan&#xD;
&#xD;
          -  Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation&#xD;
             over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Squamous cell carcinoma&#xD;
&#xD;
          -  Adenocarcinoma Stage T1-2, any N&#xD;
&#xD;
          -  T4 with one of the following:&#xD;
&#xD;
        with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or&#xD;
        total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete&#xD;
        R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed&#xD;
        consent Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto Bergamaschi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stony Brook University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roberto Bergamaschi, MD, PhD</last_name>
    <phone>631-444-2704</phone>
    <email>rbergamaschi@notes.cc.sunysb.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eileen Finnin, RN</last_name>
    <phone>631-444-5454</phone>
    <email>efinnin@notes.cc.sunysb.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>State University Hospital Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-8191</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Bergamaschi, MD, PhD</last_name>
      <phone>631-444-2704</phone>
      <email>rbergamaschi@notes.cc.sunysb.edu</email>
    </contact>
    <contact_backup>
      <last_name>Paula Denoya, MD</last_name>
      <phone>631-444-3431</phone>
      <email>pdenoya@notes.cc.sunysb.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Paula Denoya, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stony Broook University Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-8191</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Bergamaschi, MD, PhD</last_name>
      <phone>631-444-2704</phone>
      <email>rbergamaschi@notes.cc.sunysb.edu</email>
    </contact>
    <contact_backup>
      <last_name>Paula Denoya, MD</last_name>
      <phone>631-444-3431</phone>
      <email>pdenoya@notes.cc.sunysb.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Paula Denoya, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kenneth Shroyer, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Bergamaschi, MD, PhD</last_name>
      <phone>631-444-2704</phone>
      <email>rbergamaschi@notes.cc.sunysb.edu</email>
    </contact>
    <investigator>
      <last_name>Roberto Bergamaschi, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paula Denoya, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sami Khan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Meenakshi Singh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kenneth Shroyer, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Bergamaschi, MD, PhD</last_name>
      <phone>631-444-2704</phone>
      <email>rbergamaschi@notes.cc.sunysb.edu</email>
    </contact>
    <investigator>
      <last_name>Roberto Bergamaschi, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paula Denoya, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sami Khan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Meenakshi Singh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>August 11, 2011</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>April 23, 2013</last_update_submitted>
  <last_update_submitted_qc>April 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stony Brook University</investigator_affiliation>
    <investigator_full_name>Roberto Bergamaschi</investigator_full_name>
    <investigator_title>Professor and Chief, Colon and Rectal Surgery</investigator_title>
  </responsible_party>
  <keyword>rectal adenocarcinoma</keyword>
  <keyword>Standard APR</keyword>
  <keyword>Extralevator APR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702116
org study id: APR2011
nct id: NCT01702116
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: measurement of circumferential resection margin
time frame: 0-10 minutes post surgery
description: Measurement in millimeters (mm) of the circumferential resection margin.
measure: operative time
time frame: 4-6 hours
description: operative time from skin incision to skin closure
measure: hospital stay
time frame: from beginning of surgery through discharge, usually 4-5 days
description: duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)
measure: estimated blood loss
time frame: 4-6 hours
description: estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon)
arm group label: extralevator APR
arm group type: Experimental
description: This 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.
arm group label: standard APR
arm group type: Active Comparator
description: conventional abdominoperineal resection (APR)
intervention type: Procedure
intervention name: extralevator APR
description: 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.
arm group label: extralevator APR
intervention type: Procedure
intervention name: APR
description: standard Abdominoperineal Resection For Rectal Adenocarcinoma
arm group label: standard APR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberto Bergamaschi, MD, PhD
role: Principal Investigator
affiliation: Stony Brook University Medical Center
last name: Roberto Bergamaschi, MD, PhD
phone: 631-444-2704
email: rbergamaschi@notes.cc.sunysb.edu
last name: Eileen Finnin, RN
phone: 631-444-5454
email: efinnin@notes.cc.sunysb.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
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investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stony Brook University
investigator full name: Roberto Bergamaschi
investigator title: Professor and Chief, Colon and Rectal Surgery
mesh term: Adenocarcinoma
mesh term: Rectal Neoplasms