<?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>IRCT2017090236033N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-22</date_registration>
      <primary_sponsor>Vice-chancellery for Research of Mashhad University of Medicla Sciences</primary_sponsor>
      <public_title>Pathologic response, side-effects, and overall survival in cervical cancer under treatment with neo-adjuvant chemotherapy and surgery</public_title>
      <acronym></acronym>
      <scientific_title>Inquiry into pathologic response, complications, and overall survival in patients with locally advanced cervical cancer treated by neo-adjuvant chemotherapy and surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27064</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>locally advanced cervical cancer.</hc_freetext>
      <i_freetext>Intervention Group: The study has a single group. Pretreatment evaluation includes examination, pelvic magnetic resonance imaging, abdominal sonography, and chest x-ray. Patients receive three one-week periods of neo-adjuvant chemotherapy with paclitaxel (135 milligrams per square meter) on day 1 and cisplatin (75 milligrams per square meter) on day 2 every three weeks for three cycles. Patients without desirable response to chemotherapy will undergo standard pelvic chemoradiotherapy. In case the disease worsens in the 4 to 6 weeks later, the patient will undergo Wertham surgery along with three further chemotherapy cycles. The patients will be candidate for postoperative adjuvant radiation in case they have positive surgical margins, lymph nodes or parametric involvement, or at least two of the following factors: deep stromal invasion, lymphovascular invasion, or size greater than 4 centimeters in the histopathology report of the surgical specimen. Pathologic response of the tumor to treatment will be assessed at the first presentation, after each cycle, and after surgery. Complication of chemoradiotherapy (e.g., nausea, vomit, neutropenia, edema, and neauropathy) will be evaluated after each cycle. Overall survival will be assessed one year after initiation of intervention..</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 Elahe Aghel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Radiation Oncology Ward, Imam Reza Hospital, Ibn-Sina Ave.,</address>
        <city>Mashhad,</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3842 6933</telephone>
        <email>aghele941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sare Hossaini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital, Daneshgah Ave.,</address>
        <city>Mashhad,</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3842 6936</telephone>
        <email>Hossainis@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sceinces</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Definitive pathologic diagnosis of squamous cell carcinoma; stages IB2, IIA2, and IIB based on the International Federation of Gynecology and Obstetrics classification; age between 18 and 70 years; World Health Organization performance of grade 2 or lower; adequate renal and hepatic function and bone marrow reserve (i.e., absolute granulocyte count equal to or above 2×103 per liter, platelet count equal to or above 100×103 per liter; hemoglobin equal to or above 8.0 grams per deciliter, and glomerular filtration rate equal to or above 50); feasibility of follow-up in the ordered time; and informed consent. &#13;
Exclusion criteria: history of injection of chemotherapy drug in four weeks before study; serious comorbidities, for example, cardiac disease, poorly controlled diabetes mellitus, malignant hypertension, or bleeding tendency; overt infection; multiple concurrent active cancers; neuropathy grade 2 or greater; pregnancy; and history of serious hypersensitivity or allergy to cisplatin and paclitaxel.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: The study has a single group. Pretreatment evaluation includes examination, pelvic magnetic resonance imaging, abdominal sonography, and chest x-ray. Patients receive three one-week periods of neo-adjuvant chemotherapy with paclitaxel (135 milligrams per square meter) on day 1 and cisplatin (75 milligrams per square meter) on day 2 every three weeks for three cycles. Patients without desirable response to chemotherapy will undergo standard pelvic chemoradiotherapy. In case the disease worsens in the 4 to 6 weeks later, the patient will undergo Wertham surgery along with three further chemotherapy cycles. The patients will be candidate for postoperative adjuvant radiation in case they have positive surgical margins, lymph nodes or parametric involvement, or at least two of the following factors: deep stromal invasion, lymphovascular invasion, or size greater than 4 centimeters in the histopathology report of the surgical specimen. Pathologic response of the tumor to treatment will be assessed at the first presentation, after each cycle, and after surgery. Complication of chemoradiotherapy (e.g., nausea, vomit, neutropenia, edema, and neauropathy) will be evaluated after each cycle. Overall survival will be assessed one year after initiation of intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Edema. Timepoint: after each course of chemotherapy. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Clinical response of tumor to treatment. Timepoint: At the first presentation, after each cycle of chemotherapy, and after surgery. Method of measurement: Physical examination and pathology.</prim_outcome>
      <prim_outcome>Overall survival. Timepoint: On year after initiation of treatment. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Nausea. Timepoint: after each course of chemotherapy. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Vomit. Timepoint: after each course of chemotherapy. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Neutropenia. Timepoint: after each course of chemotherapy. Method of measurement: complete blood count.</prim_outcome>
      <prim_outcome>Neuropathy. Timepoint: after each course of chemotherapy. Method of measurement: Clinical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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 Medicla Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-08</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vice-chancellery for Reasearch, 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>
