xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05984576</url>
    </required_header>
    <id_info>
      <org_study_id>5579</org_study_id>
      <nct_id>NCT05984576</nct_id>
    </id_info>
    <brief_title>Radiotherapy &amp; Total Neoadjuvant Therapy for Recurrent Rectal Cancer in Previously Irradiated Patients, an Italian Association for Radiotherapy and Clinical Oncology (AIRO)-GI Platform: a Multi-centre Prospective Observational Study</brief_title>
    <acronym>RETRY</acronym>
    <official_title>Radiotherapy &amp; Total Neoadjuvant Therapy for Recurrent Rectal Cancer in Previously Irradiated Patients, an Italian Association for Radiotherapy and Clinical Oncology (AIRO)-GI Platform: a Multi-centre Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The introduction of neoadjuvant chemoradiation therapy (CRT) and the use of advanced surgical&#xD;
        techniques have led to a reduction in mortality and recurrence rates for rectal cancer, the&#xD;
        rate of which currently stands at 4-8%. Complete cytoreduction (achieving R0) of local&#xD;
        recurrence is the main factor correlating with survival, but surgery can often be very&#xD;
        complex because of the change in anatomical planes caused by previous surgery. Reirradiation&#xD;
        of the recurrence may increase the rate of optimal resection (R0) and may palliate symptoms&#xD;
        in unresectable disease. It is a very complex procedure, because one has to take into account&#xD;
        the dose previously received by the organs at risk (OARs) and at the same time be able to&#xD;
        deliver an effective dose to the recurrence. However with modern irradiation techniques&#xD;
        (VMAT) it is possible to increasingly spare the OARs and deliver adequate doses in this&#xD;
        setting as well.&#xD;
  &#xD;
        Besides radiotherapy with conventional fractionation, other promising options are&#xD;
        stereotactic body radiotherapy (SBRT) with and proton (PT) and carbon ion RT (CIRT). Another&#xD;
        topic of interest is chemotherapy intensification (CHT): recent studies of concomitant and&#xD;
        neoadjuvant chemotherapy (Total Neoadjuvant Therapy) have shown high rates of antitumour&#xD;
        response, however even this option should be evaluated with caution, because it must take&#xD;
        into account previous cancer treatments received by the patient.&#xD;
  &#xD;
        Based on the evidence reported in the literature, it is reasonable to assume that treatment&#xD;
        of local recurrence of rectal cancer should be multimodal, integrating surgical treatment&#xD;
        with CHT and RT, using the different technologies available. To this end, proper&#xD;
        stratification of patients is necessary in order to target the appropriate therapy according&#xD;
        to the type of recurrence and their clinical condition.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 21, 2023</start_date>
    <completion_date type="Anticipated">June 5, 2031</completion_date>
    <primary_completion_date type="Anticipated">June 5, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Local control</measure>
      <time_frame>8 years</time_frame>
      <description>The primary aim of this study is to investigate whether the combination of total neoadjuvant therapy (TNT) with re-RT could lead to a better Local Control rate in Local recurrent rectal cancer patients previously irradiated.</description>
    </primary_outcome>
    <enrollment type="Anticipated">88</enrollment>
    <condition>Rectal Neoplasm</condition>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Reirradiation</intervention_name>
      <description>Reirradiation recurrent rectal cancer</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Recurrent rectal cancer previously irradiated&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years old;&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) 0-1;&#xD;
  &#xD;
            -  Adequate hematological function, i.e.:&#xD;
  &#xD;
            -  Granulocyte count &gt; 1500/µL;&#xD;
  &#xD;
            -  Hemoglobin level &gt;10 g/dL;&#xD;
  &#xD;
            -  Platelet count &gt; 100000/µL;&#xD;
  &#xD;
            -  Alanine aminotransferase (ALT)/aspartate aminotransferase (AST): 7-45 international&#xD;
               units (UI)/L.&#xD;
  &#xD;
            -  Potentially curable Oligo-metastatic disease;&#xD;
  &#xD;
            -  Life expectancy of more than 24 months;&#xD;
  &#xD;
            -  Histologically (if feasible) or radiologically MRI (magnetic resonance imaging), if no&#xD;
               contraindications, and CT (computed tomography) and/or Positron Emission Tomography&#xD;
               scan (PET) proven pelvic local recurrent rectal cancer (LRRC);&#xD;
  &#xD;
            -  Previous pelvic irradiation &gt; 6 months;&#xD;
  &#xD;
            -  Availability of the previous treatment plan in DICOM format only (Digital Imaging and&#xD;
               COmmunications in Medicine).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 y.o.;&#xD;
  &#xD;
            -  Pregnancy or lactating female patients;&#xD;
  &#xD;
            -  Psychological, familial, sociological or geographical condition potentially hampering&#xD;
               compliance with the study protocol and follow-up schedule (those conditions should be&#xD;
               discussed with the patient before registration in the trial);&#xD;
  &#xD;
            -  Important comorbidities (such as: severe cardiac or coagulative disease, moderate or&#xD;
               severe restrictive/obstructive lung deficit, severe cognitive impairment, moderate and&#xD;
               severe renal and hepatic impairment.&#xD;
  &#xD;
            -  Refusal to sign written informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fondazione Policlinico Gemelli</name>
        <address>
          <city>Rome</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maria Antonietta Gambacorta, Prof</last_name>
        <phone>0630157894</phone>
        <email>radioterapia@policlinicogemelli.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>GAMBACORTA MARIA ANTONIETTA</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Radiotherapy</keyword>
    <keyword>Reirradiation</keyword>
    <keyword>Recurrent Rectal Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05984576
  org study id: 5579
  nct id: NCT05984576
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The introduction of neoadjuvant chemoradiation therapy (CRT) and the use of advanced surgical
        techniques have led to a reduction in mortality and recurrence rates for rectal cancer, the
        rate of which currently stands at 4-8%. Complete cytoreduction (achieving R0) of local
        recurrence is the main factor correlating with survival, but surgery can often be very
        complex because of the change in anatomical planes caused by previous surgery. Reirradiation
        of the recurrence may increase the rate of optimal resection (R0) and may palliate symptoms
        in unresectable disease. It is a very complex procedure, because one has to take into account
        the dose previously received by the organs at risk (OARs) and at the same time be able to
        deliver an effective dose to the recurrence. However with modern irradiation techniques
        (VMAT) it is possible to increasingly spare the OARs and deliver adequate doses in this
        setting as well.
  
        Besides radiotherapy with conventional fractionation, other promising options are
        stereotactic body radiotherapy (SBRT) with and proton (PT) and carbon ion RT (CIRT). Another
        topic of interest is chemotherapy intensification (CHT): recent studies of concomitant and
        neoadjuvant chemotherapy (Total Neoadjuvant Therapy) have shown high rates of antitumour
        response, however even this option should be evaluated with caution, because it must take
        into account previous cancer treatments received by the patient.
  
        Based on the evidence reported in the literature, it is reasonable to assume that treatment
        of local recurrence of rectal cancer should be multimodal, integrating surgical treatment
        with CHT and RT, using the different technologies available. To this end, proper
        stratification of patients is necessary in order to target the appropriate therapy according
        to the type of recurrence and their clinical condition.
  observational model: Other
  time perspective: Prospective
  measure: Local control
  time frame: 8 years
  description: The primary aim of this study is to investigate whether the combination of total neoadjuvant therapy (TNT) with re-RT could lead to a better Local Control rate in Local recurrent rectal cancer patients previously irradiated.
  intervention type: Radiation
  intervention name: Reirradiation
  description: Reirradiation recurrent rectal cancer
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: GAMBACORTA MARIA ANTONIETTA
  investigator title: Professor
  mesh term: Rectal Neoplasms