<?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>IRCT2017091428815N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-28</date_registration>
      <primary_sponsor>Vice-chancellery for Research of Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Results and complications of intraoperative radiotherapy as boost after neoadjuvant chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>A clinical trial evaluating the results and complications of intraoperative radiotherapy as boost after neoadjuvant chemotherapy in patients with nonmetastatic breast cancer candidate for breast conserving surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>a detectable marker will be inserted under the guide of sonography in the tumor. Afterwards, the patients will receive neoadjuvant chemotherapy based on the standards of the treating institute. Before each course of chemotherapy, the patients will be examined for clinical response to chemotherapy. At the end of neoadjuvant treatment, the patients will undergo full physical examination and mammographic and sonographic assessment. In case of appropriate clinical response, the patients will undergo lumpectomy two weeks after completion of neoadjuvant treatment. During surgery, the patients will receive 20 gray intraoperative radiotherapy by intrabeam system Zeiss. After surgery, the patients will receive external beam radiotherapy (50 gray to the whole breast and 45 to 50 gray to the supraclavicular lymph node). Patients will be followed up every 3 months during the first 2 year, and then every 6 months until 5 years by physical examination and annual mammography (or sonography in case of dense breast)..</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Alireza Keramati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koohsangi Ave.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>917661377</zip>
        <telephone>+98 51 3842 6083</telephone>
        <email>keramatia941@mums.ac.ir</email>
        <affiliation>Omid Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Fatemeh Homaee Shandiz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koohsangi Ave.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3842 6083</telephone>
        <email>@mums.ac.irHomaeeF</email>
        <affiliation>Omid Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Women between 30 and 70 years old; informed consent for participation; pathologic confirmation of invasive ductal carcinoma of breast; tumor stages of T3N1M0, T3N0M0, T2N1M0, and T2N0M0 based on classification of American Joint Committee on Cancer; and operable breast cancer patient who is candidate for breast conserving surgery. &#13;
Exclusion criteria: Pregnancy and breast feeding; active collagen vascular diseases like scleroderma; history of chest wall radiotherapy for Hodgkin lymphoma; multifocal breast cancer in two separate quadrants of breast; presence of metastasis during treatment; and poor clinical response to the neoadjuvant chemotherapy.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Breast, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>a detectable marker will be inserted under the guide of sonography in the tumor. Afterwards, the patients will receive neoadjuvant chemotherapy based on the standards of the treating institute. Before each course of chemotherapy, the patients will be examined for clinical response to chemotherapy. At the end of neoadjuvant treatment, the patients will undergo full physical examination and mammographic and sonographic assessment. In case of appropriate clinical response, the patients will undergo lumpectomy two weeks after completion of neoadjuvant treatment. During surgery, the patients will receive 20 gray intraoperative radiotherapy by intrabeam system Zeiss. After surgery, the patients will receive external beam radiotherapy (50 gray to the whole breast and 45 to 50 gray to the supraclavicular lymph node). Patients will be followed up every 3 months during the first 2 year, and then every 6 months until 5 years by physical examination and annual mammography (or sonography in case of dense breast).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Two-year disease-free survival. Timepoint: every 3 months. Method of measurement: physical examination and mammography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dermatitis. Timepoint: every 3 months in the first two years; every 6 months in the third to fifth years after intervention. Method of measurement: physical examination.</sec_outcome>
      <sec_outcome>Skin necrosis. Timepoint: every 3 months in the first two years; every 6 months in the third to fifth years after intervention. Method of measurement: physical examination.</sec_outcome>
      <sec_outcome>Beauty. Timepoint: every 3 months in the first two years; every 6 months in the third to fifth years after intervention. Method of measurement: physical examination.</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>Vice-chancellery for Research of Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-08</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vice-chancellery for Research, Mashhad University of Medical Sciences, Daneshgah Ave., Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
