<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180919041070N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-21</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Rectal retractor in prostate cancer</public_title>
      <acronym></acronym>
      <scientific_title>Clinical evaluation and comparison of rectal toxicity and absorbed dose effects of radiation therapy with and without rectal retractor on patients with  prostate cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46385</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization is used to randomize subjects. The block size is Four (Two patients in the intervention group and Two patient in the control group). For random allocation, since 36 patients should be allocated in two groups of 18, nine random blocks (each block consisting of four patients) are generated using an online software (WWW.sealedenvelope.com).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prostate cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients who are treated with rectal retractor in order to retract the rectum and distance it from prostate, Intervention: A rectal retractor probe which is designed with CATIA V5R2 software and is constructed by Mahdavi et. al. in Iran University of Medical Sciences. The probe is made of Acrylic which is equivalent to body tissue.The rectal retractor is used in the intervention group for 20 sessions of 35sessions of radiation therapy treatment sessions. Intervention 2: Control group: Patients with localized prostate cancer who are treated with 35 sessions radiation therapy without rectal retractor.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information about main outcomes of the study

When:
Six months after publishing the results

To whom:
Researchers in universities and scientific and research centers

Conditions:
In order to improve the treatment of the disease and subsequent research and with the permission of the authors

Where to obtain:
Department of Radiation Oncology of Iran University of Medical Sciences

How to obtain:
Sending the request in writing or by email to the authors

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahshid Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Firoozgar Hospital, Beh Afarin St, Valiasr Sq., District 6</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15937-47811</zip>
        <telephone>+98 21 8214 1201</telephone>
        <email>mahshid.abbasi2011@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pedram Fadavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Firoozgar Hospital, Beh Afarin St, Valiasr Sq., District 6</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15937-47811</zip>
        <telephone>+98 21 8214 1201</telephone>
        <email>Fadavi.p@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with localized prostate cancer who are candidates for  radiation therapy with 5 fields technique
pathologically confirmed prostate cancer in patients who have not undergone prostate surgery</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Anorectal disorders (Hemorrhoidsm, rectal fistula)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of prostate</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients who are treated with rectal retractor in order to retract the rectum and distance it from prostate, Intervention: A rectal retractor probe which is designed with CATIA V5R2 software and is constructed by Mahdavi et. al. in Iran University of Medical Sciences. The probe is made of Acrylic which is equivalent to body tissue.The rectal retractor is used in the intervention group for 20 sessions of 35sessions of radiation therapy treatment sessions.</i_keyword>
      <i_keyword>Control group: Patients with localized prostate cancer who are treated with 35 sessions radiation therapy without rectal retractor</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Early and late lower gastrointestinal complications grade based on Radiation therapy oncology group (RTOG) criteria. Timepoint: During treatment course, 1-3 months after treatment, 9-12 months after treatment. Method of measurement: according to Radiation therapy oncology group (RTOG) criteria.</prim_outcome>
      <prim_outcome>Rectum to prostate distance in CT scan images. Timepoint: At the beginning of study (During intervention). Method of measurement: Axial CT scan images.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maximum dose (Dmax). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6  ).</sec_outcome>
      <sec_outcome>Minimum dose (Dmin). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6  ).</sec_outcome>
      <sec_outcome>Mean dose (Dmean). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6  ).</sec_outcome>
      <sec_outcome>Dose 30% (D30%): The dose that covers 30% of rectum. Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6  ).</sec_outcome>
      <sec_outcome>Dose 50% (D50%): The dose that covers 50% of rectum. Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6  ).</sec_outcome>
      <sec_outcome>Dose volume histograms for rectum and planning treatment volume (PTV). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6  ).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-07</approval_date>
        <contact_name>Research Ethics Committee of Medical School of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
