<?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>IRCT20200803048281N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-29</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of chemotherapy in rectal cancer</public_title>
      <acronym></acronym>
      <scientific_title>The evaluation of pathologic complete response and clinical complete response in locally advanced rectal cancer who treated with total neoadjuvant therapy compared with standard treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52086</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomized to two groups by Permuted block method;The group treated with TNT approach and the group treated with standard treatment.
Randomization method: block
Randomization unit: individual
Randomization tool: online software (Sealed Envelope Ltd. 2020)
How to make a random sequence: Online software at:
https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 6 Nov 2020].</study_design>
      <phase>3</phase>
      <hc_freetext>Rectal cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will include patients who have all chemotherapy sessions before surgery, 3 sessions before radiotherapy and 3 sessions after radiotherapy. Medications include oxaliplatin 135 mg / m2, d1, and capecitabine (ACTe) 1000 mg / m2, d1-d14 every three weeks.  Concurrently with radiotherapy, capcitabine 825 mg / m2 is prescribed during the radiotherapy treatment. Intervention 2: Control group: The control group includes patients who are treated by the standard protocol; preoperative chemoradiation and postoperative chemotherapy. Capecitabin is prescribed at a dose of 825 mg /m2 during radiotherapy, and after surgery, chemotherapy includes oxaliplatin 135 mg / m2, d1 and capecitabin (Acte company) 1000 mg / m2, d1-d14 every three weeks up to 5-6 courses.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Moshtaghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cancer institute, Imam khomeini hospital complex, Qarib st, Keshavarz blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733147</zip>
        <telephone>+98 21 6119 2585</telephone>
        <email>mahsa.moshtaghian@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Babaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cancer institute, Imam khomeini hospital complex, Qarib st, Keshavarz blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2585</telephone>
        <email>m-babaei@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with pathologically confirmed rectal cancer who are in locally advanced stage based on imaging</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients diagnosed with Renal disease who are not candidates for chemotherapy or need to adjust the dose
Patients diagnosed with hepatic disease who are not candidates for chemotherapy or need to adjust the dose
Patients diagnosed with Cardiovascular disease who are not candidates for chemotherapy
Patients with underlying colorectal disease such as Crohn's disease or ulcerative collitis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of rectum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will include patients who have all chemotherapy sessions before surgery, 3 sessions before radiotherapy and 3 sessions after radiotherapy. Medications include oxaliplatin 135 mg / m2, d1, and capecitabine (ACTe) 1000 mg / m2, d1-d14 every three weeks.  Concurrently with radiotherapy, capcitabine 825 mg / m2 is prescribed during the radiotherapy treatment.</i_keyword>
      <i_keyword>Control group: The control group includes patients who are treated by the standard protocol; preoperative chemoradiation and postoperative chemotherapy. Capecitabin is prescribed at a dose of 825 mg /m2 during radiotherapy, and after surgery, chemotherapy includes oxaliplatin 135 mg / m2, d1 and capecitabin (Acte company) 1000 mg / m2, d1-d14 every three weeks up to 5-6 courses.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pathologic Complete response to treatment. Timepoint: Before the surgery. Method of measurement: Based on preoperative history, examination and imaging.</prim_outcome>
      <prim_outcome>Pathologic Complete response to treatment. Timepoint: After the surgery. Method of measurement: Based on the surgical pathology report.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age. Timepoint: Before the intervention. Method of measurement: Asking the patient, patient ID card.</sec_outcome>
      <sec_outcome>Sex. Timepoint: Before the intervention. Method of measurement: Patient ID card.</sec_outcome>
      <sec_outcome>Performance. Timepoint: Before the intervention. Method of measurement: Based on Eastern Cooperative Oncology Group criteria.</sec_outcome>
      <sec_outcome>Hematologic disorders. Timepoint: Before the intervention, weekly during chemotherapy and radiotherapy, and after treatment. Method of measurement: Complete blood count test.</sec_outcome>
      <sec_outcome>Gastrointestinal side effects. Timepoint: Weekly during chemotherapy and radiotherapy. Method of measurement: Asking the patient, according to the Common Terminology Criteria for Adverse Events.</sec_outcome>
      <sec_outcome>Neuropathic complications. Timepoint: Weekly during chemotherapy and radiotherapy. Method of measurement: Asking the patient, according to the Common Terminology Criteria for Adverse Events.</sec_outcome>
      <sec_outcome>Staging of the disease. Timepoint: Before the intervention. Method of measurement: Based on endosonogeraphy or MRI.</sec_outcome>
      <sec_outcome>Tumor distance from anal verge. Timepoint: Before the intervention. Method of measurement: Based on colonoscopy or endosonogeraphy or MRI.</sec_outcome>
      <sec_outcome>Chemotherapy regimen. Timepoint: Before the chemotherapy. Method of measurement: Patient's file.</sec_outcome>
      <sec_outcome>Radiotherapy technique. Timepoint: Before the radiation therapy. Method of measurement: Patient's file.</sec_outcome>
      <sec_outcome>Radiotherapy dose. Timepoint: Before the treatment. Method of measurement: Patient's file.</sec_outcome>
      <sec_outcome>Concurrent chemotherapy with radiotherapy. Timepoint: Before the treatment. Method of measurement: Patient's file.</sec_outcome>
      <sec_outcome>Number of days between the last session of neoadjuvant treatment to surgery. Timepoint: Between the last session of neoadjuvant treatment to surgery. Method of measurement: Patient's file.</sec_outcome>
      <sec_outcome>Number of days between the surgery to adjuvant treatment. Timepoint: Between the surgery to adjuvant treatment. Method of measurement: Patient's file.</sec_outcome>
      <sec_outcome>Type of the surgery Low anterior resection or Abdominoperineal resection. Timepoint: After the surgery. Method of measurement: Patient's file.</sec_outcome>
      <sec_outcome>Tumor margins in surgery. Timepoint: After the surgery. Method of measurement: Pathology report.</sec_outcome>
      <sec_outcome>Response rate to treatment. Timepoint: After surgery. Method of measurement: Pathology report, based on Tumor regression grade.</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>2019-09-04</approval_date>
        <contact_name>Ethics Committee in Research of Imam Khomeini Hospital Complex - Tehran University of Medical Scienc</contact_name>
        <contact_address>Imam Khomeini Hospital Complex, Gharib St., Keshavarz Boulevard. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
