<?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>IRCT20201220049776N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-27</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of 3-weekly  administration of continuous dose cisplatin with divided dose in head and neck carcinoma</public_title>
      <acronym></acronym>
      <scientific_title>Complication assessment of concurrent chemoradiotherapy with 100 mg/m2 continuous dose vs 100 mg/m2 divided into three consecutive days in patients with head and neck squamous cell carcinoma , A Randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53206</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization 60 participants was planned by 15 random blocks of 4, each including two interventions and two controls via online system (http://sealedenvelope.com). In order to apply concealment, unique codes was produced by the online system. Physicians knew the codes and  after enrollment the participants allocated group become visible to patients and physicians by the physician's secretory.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Malignant neoplasm of base of tongue. Condition 2: Malignant neoplasm of other and unspecified parts of tongue. Condition 3: Malignant neoplasm of oropharynx. Condition 4: Malignant neoplasm of nasopharynx. Condition 5: Malignant neoplasm of hypopharynx. Condition 6: Malignant neoplasm of pyriform sinus. Condition 7: Malignant neoplasm of larynx.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In this group, they received cisplatin every 21 days  at a dose of 100 mg per cubic meter divided into three consecutive days. Chemotherapy courses were between 2 and 3 courses during the course of radiation therapy. Intervention 2: Control group: In this group, they received cisplatin every 21 days at a dose of 100 mg per cubic meter continuously in 24 hours. Chemotherapy courses were between 2 and 3 courses during the course.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arefeh Saeedian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, at the end of Keshavarz Boulevard, Dr. Gharib Street. Imam Khomeini Hospital Complex</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2587</telephone>
        <email>a-saeedian@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Aghili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, at the end of Keshavarz Boulevard, Dr. Gharib Street;Imam Khomeini Hospital Complex</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2587</telephone>
        <email>aghili@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men and women under 70 years of age, known case of head and neck SCC with karnofsky performance status &gt;= 70%
Definitive chemoradiation or adjuvant chemoradiation in patients with extranodal extension or positive margin
Radiation dose 66-70 Gy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of chemotherapy
Kidney disease and Diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C01</hc_code>
      <hc_code>C02</hc_code>
      <hc_code>C10</hc_code>
      <hc_code>C11</hc_code>
      <hc_code>C13</hc_code>
      <hc_code>C12</hc_code>
      <hc_code>C32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of base of tongue</hc_keyword>
      <hc_keyword>Malignant neoplasm of other and unspecified parts of tongue</hc_keyword>
      <hc_keyword>Malignant neoplasm of oropharynx</hc_keyword>
      <hc_keyword>Malignant neoplasm of nasopharynx</hc_keyword>
      <hc_keyword>Malignant neoplasm of hypopharynx</hc_keyword>
      <hc_keyword>Malignant neoplasm of pyriform sinus</hc_keyword>
      <hc_keyword>Malignant neoplasm of larynx</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In this group, they received cisplatin every 21 days  at a dose of 100 mg per cubic meter divided into three consecutive days. Chemotherapy courses were between 2 and 3 courses during the course of radiation therapy.</i_keyword>
      <i_keyword>Control group: In this group, they received cisplatin every 21 days at a dose of 100 mg per cubic meter continuously in 24 hours. Chemotherapy courses were between 2 and 3 courses during the course.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mucositis. Timepoint: Weekly during radiation for 7 weeks. Method of measurement: Examination.</prim_outcome>
      <prim_outcome>Disphasia. Timepoint: Weekly during radiation for 7 weeks. Method of measurement: Examination.</prim_outcome>
      <prim_outcome>Cytopenia. Timepoint: Weekly during radiation for 7 weeks. Method of measurement: Laboratory data.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disease free survival. Timepoint: 18 months. Method of measurement: Phone calls. Visit at the Office.</sec_outcome>
      <sec_outcome>Overall survival. Timepoint: 18 months. Method of measurement: Phone calls. Visit at the Office.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-02</approval_date>
        <contact_name>National Ethics Committee in Biomedical Research</contact_name>
        <contact_address>Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
