<?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>IRCT201203225283N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-28</date_registration>
      <primary_sponsor>Women's Reproductive Health Research Center, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison  the results of combination platinium based neoadjuvant chemotherapy regimens using gemcitabin/ciplatin with carboplatin/paclitaxel in advanced stage ovarian cancer patients; A RCT</public_title>
      <acronym></acronym>
      <scientific_title>Comparison  the results of combination platinium based neoadjuvant chemotherapy regimens using gemcitabin/ciplatin with carboplatin/paclitaxel in advanced stage ovarian cancer patients; A RCT</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>206</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5654</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with advanced serous ovarian cancer, Figo stage III and IV.</hc_freetext>
      <i_freetext>Intervention 1: For first group, at first daycombination ofgemcitabin (1000 mg per square meter on days 1 and 8 IV during 30 minutes) and cisplatin (75 mg per square meter, IV) are administrated. This protocol can be repeated every 21 days. This protocol is  repeated every 21 days,  and up to 3 courses of chemotherapy is done. Then   patients undergo immediate interval debulking surgery. Intervention 2: For  group 2, combination of carboplatin (carboplatin at an area under the concentration-time curve (AUC) of 5-6 mg/mL/min IV over 1 hour and  paclitaxel (175 mg per square meter IV over 3 hours) on the first day will be prescribed. This protocol is  repeated every 21 days,  and up to 3 courses of chemotherapy is done. Then   patients undergo immediate interval debulking surgery.</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>Manizheh Sayyah-Melli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South ArteshAve.,Tabriz, Iran.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1553 9161</telephone>
        <email>manizheh.sayyahmelli@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Manizheh sayyah-melli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South ArteshAve.,Tabriz, Iran.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1553 9161</telephone>
        <email>manizheh.sayyahmelli@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with advanced serous ovarian cancer Figo Stage III and IV; the volume of ascites, that is determined by ultrasound or CT scan, more than  500cc</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>90 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>c56</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of ovary</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>For first group, at first daycombination ofgemcitabin (1000 mg per square meter on days 1 and 8 IV during 30 minutes) and cisplatin (75 mg per square meter, IV) are administrated. This protocol can be repeated every 21 days. This protocol is  repeated every 21 days,  and up to 3 courses of chemotherapy is done. Then   patients undergo immediate interval debulking surgery.</i_keyword>
      <i_keyword>For  group 2, combination of carboplatin (carboplatin at an area under the concentration-time curve (AUC) of 5-6 mg/mL/min IV over 1 hour and  paclitaxel (175 mg per square meter IV over 3 hours) on the first day will be prescribed. This protocol is  repeated every 21 days,  and up to 3 courses of chemotherapy is done. Then   patients undergo immediate interval debulking surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>CA-125 levels. Timepoint: before surgery. Method of measurement: Lab measurement.</prim_outcome>
      <prim_outcome>The volume of residual tumor. Timepoint: During  surgery. Method of measurement: Clinical judgment.</prim_outcome>
      <prim_outcome>The volume of ascites. Timepoint: During surgery. Method of measurement: Clinical estimation.</prim_outcome>
      <prim_outcome>Bleeding. Timepoint: During surgery. Method of measurement: Clinical estimation.</prim_outcome>
      <prim_outcome>Surgery duration. Timepoint: During surgery. Method of measurement: During surgery.</prim_outcome>
      <prim_outcome>Death during surgery. Timepoint: During surgery. Method of measurement: observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Wound infection, dehicsence, nausea, vomiting,diarrhea, illeus, intestinal obstruction, hospital stay. Timepoint: 24 h after surgery. Method of measurement: observation, ultrasonography, CT-scan.</sec_outcome>
      <sec_outcome>Ascites collection. Timepoint: 24 hours after surgery. Method of measurement: observation, ultrasonography, CT-scan.</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>Women's Reproductive Health Research Center, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-05-24</approval_date>
        <contact_name>Tabriz University of medical Sciences</contact_name>
        <contact_address>Golgasht Ave., Vice Chancellor deputy of Research, Tabriz University of medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
