<?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>IRCT20210306050600N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-26</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Brachytherapy with concurrent Capecitabine  in advanced cervical cancer</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of addition of concurrent Capecitabine to brachytherapy in patients with advanced cervical cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54921</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: Patient who are recruited into the trial, will be placed in the intervention arm. Control group will be matched patients who have not received concomitant chemotherapy with brachytherapy,  either have not entered the trial or those  previously treated.</study_design>
      <phase>2</phase>
      <hc_freetext>Cervical cancer, FIGO stage IB-IVA.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients who are eligible to enter the trial, are put on Capecitabine 825mg/m2 twice daily during their brachytherapy treatment, starting from the first fraction of their brachytherapy treatment till the last fraction, which can take between 10-14 days. Capecitabine is an oral chemotherapy drug, which can also increase the sensitivity of cells to radiation. In this study, capecitabine-ACTE will be used. Intervention 2: Control group: patients who have received the current standard treatment, that is brachytherapy done without concurrent chemotherapy, are compared with intervention group after they are matched based on variables like stage of disease, comorbidities and performance status. This group can be chosen from the patients who have not entered the trial, or patients who have received the standard treatment in the past.</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:
De-identified demographic information and data about the primary outcome measures will be shared

When:
starting 6 months after the publication

To whom:
data will only  be available to people working in academic institutions

Conditions:
data will only be available for research oriented prurposes

Where to obtain:
In order to access the data, applicant should send an email requesting access, to Dr Soudeh Arastouei(arastoueis971@mums.ac.ir)

How to obtain:
After receiving the email, communication will be done with the ethic committee of Mashad university of medical sciences for further authorization

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soudeh Arastouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Omid Hospital, Alandasht square, Kooh-Sangi Avenue</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176613775</zip>
        <telephone>+98 51 3842 6082</telephone>
        <email>arastoueis971@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Homaei Shandiz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Omid hospital, Alandasht square, Kooh-Sangi Avenue</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176613775</zip>
        <telephone>+98 51 3842 6082</telephone>
        <email>HomaeeF@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</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>definite diagnosis of cervical cancer in the pathological sample
histology of SCC or Adenocarcinoma
stage IB-IVA based on gynecologic examination and imaging, making these patients chemoradiotherapy candidates
no evidence of distant metastasis
adequate performance status ( ECOG ≥2)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>not willing to enter the trial
uncontrolled  comorbidities, like diabetes mellitus and hypertension
warfarin use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C53</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of cervix uteri</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: patients who are eligible to enter the trial, are put on Capecitabine 825mg/m2 twice daily during their brachytherapy treatment, starting from the first fraction of their brachytherapy treatment till the last fraction, which can take between 10-14 days. Capecitabine is an oral chemotherapy drug, which can also increase the sensitivity of cells to radiation. In this study, capecitabine-ACTE will be used.</i_keyword>
      <i_keyword>Control group: patients who have received the current standard treatment, that is brachytherapy done without concurrent chemotherapy, are compared with intervention group after they are matched based on variables like stage of disease, comorbidities and performance status. This group can be chosen from the patients who have not entered the trial, or patients who have received the standard treatment in the past.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disease free survival. Timepoint: every 3 months after intervention for 12 months. Method of measurement: Using patients' registries, which are the result of patient's follow up visits every three months after completion of treatment to the treating doctor.  Recurrence could be proved using biopsy or imaging.</prim_outcome>
      <prim_outcome>Acute Gastrointestinal side effects:  nausea and vomiting. Timepoint: During each brachytherapy session. which happens every second or third day. Method of measurement: By history taking, and the severity of this side effect will be recorded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.</prim_outcome>
      <prim_outcome>Acute hematologic side effects: Anemia. Timepoint: during every brachytherapy session which is done every second or third day or weeky during intervention. Method of measurement: By history taking, and looking for signs of cytopenias, like bruises, fever, weakness and mucositis. In case of suggesting history, Complete blood count is requested, otherwise a routine Complete blood count is done weekly.</prim_outcome>
      <prim_outcome>Acute hematologic side effects: leucopenia. Timepoint: During every brachytherapy session which is done every second or third day or weeky during intervention. Method of measurement: By history taking, and looking for signs of leukopenia, like fever and mucositis. In case of suggesting history, Complete blood count is requested, otherwise a routine Complete blood count is done weekly.</prim_outcome>
      <prim_outcome>Acute gastrointestinal side effects: diarrhoea. Timepoint: During each brachytherapy session, which happens every second or third day. Method of measurement: By history taking, and the severity of this side effect will be recorded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.</prim_outcome>
      <prim_outcome>Hand foot syndrome. Timepoint: During each brachytherapy session, which happens every second or third day. Method of measurement: By physical examination, and the severity of this side effect will be recorded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Overall survival( survival from the time of diagnosis till death). Timepoint: every 3 months after the intervention. Method of measurement: Results of 12 months of follow up of patients regarding overall survival will be recorded using patient's records or in case of lack of adherence to follow up, through phone call.</sec_outcome>
      <sec_outcome>Acute hematologic side effect: Thrombocytopenia. Timepoint: Every brachytherapy session, which happens every second or third day. Method of measurement: By history taking, asking for any bleeding or bruises, in case of positive history a complete blood count is requested. In case of negative history, a complete blood count is routinely done weekly during brachytherapy treatment, which takes ten to fourteen days,.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-28</approval_date>
        <contact_name>Ethics committee of Mashad University of medical Sciences</contact_name>
        <contact_address>Daneshgah Avenue Mashad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
