<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/NCT03803436</url>
  </required_header>
  <id_info>
    <org_study_id>INT 108/18</org_study_id>
    <nct_id>NCT03803436</nct_id>
  </id_info>
  <brief_title>Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation</brief_title>
  <acronym>COLT</acronym>
  <official_title>Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation: a Prospective Parallel Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Istituto Di Ricerche Farmacologiche Mario Negri</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gruppo Oncologico del Nord-Ovest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The COLT trial is an investigator-driven, multicenter, non-randomized, open-label,&#xD;
      controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall&#xD;
      survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a&#xD;
      matched cohort of patients bearing the same tumor characteristics, collected during the same&#xD;
      time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study will compare survival in the population of patients enrolled in the COLT trial with the OS in the COLT-eligible population enrolled in the parallel TRIPLETE trial conducted by the GONO Group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>5 years</time_frame>
    <description>Time from enrolement to either death or censoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>5 years</time_frame>
    <description>Time from enrolement to either progression or censoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications rate</measure>
    <time_frame>90 days after liver transplant</time_frame>
    <description>Complications according to Dindo Clavien Classification</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Liver Metastases</condition>
  <condition>Colorectal Cancer Metastatic</condition>
  <condition>Liver Neoplasm</condition>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Study arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liver transplant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parallel arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver transplant</intervention_name>
    <description>Liver transplant from cadaveric donors</description>
    <arm_group_label>Study arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>mFOLFOX</description>
    <arm_group_label>Parallel arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Panitumumab</description>
    <arm_group_label>Parallel arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed non-mucinous colon adenocarcinoma.&#xD;
&#xD;
          -  Primary tumor as pT1-3, pN0 or pN1 (metastases in &lt; 4 regional lymph nodes), confirmed&#xD;
             R0 resection.&#xD;
&#xD;
          -  RAS and BRAF wild-type &amp; MSS molecular status as per local testing.&#xD;
&#xD;
          -  Liver metastases not eligible for curative liver resection&#xD;
&#xD;
          -  Objective response according to RECIST 1.1 to first-line treatment, with sustained&#xD;
             response for at least 4 months, OR disease control (CR+PR+SD) during second-line&#xD;
             treatment for at least 4 months.&#xD;
&#xD;
          -  A maximum of two prior chemotherapy treatment lines.&#xD;
&#xD;
          -  Performance status, ECOG 0.&#xD;
&#xD;
          -  Satisfactory blood tests Hb &gt;10g/dl, neutrophils &gt;1.0 (after any G-CSF), TRC &gt;75,&#xD;
             Bilirubin&lt;2 x upper normal level, AST, ALT&lt;5 x upper normal level, creatinine &lt;1.25 x&#xD;
             upper normal level.&#xD;
&#xD;
          -  CEA&lt;50 ng/ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hereditary CRC syndromes including FAP and Lynch syndrome.&#xD;
&#xD;
          -  Prior extra hepatic metastatic disease or primary tumor local relapse.&#xD;
&#xD;
          -  Extra-peritoneal cancers (rectum).&#xD;
&#xD;
          -  Other malignancies in the previous 5 years&#xD;
&#xD;
          -  Active intra-venous or alcohol abusers&#xD;
&#xD;
          -  HIV infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincenzo Mazzaferro, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Istituto Nazionale Tumori di Milano</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vincenzo Mazzaferro, MD, PhD</last_name>
    <phone>+39 02 23902760</phone>
    <email>segreteria.mazzaferro@istitutotumori.mi.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carlo Sposito, MD</last_name>
    <phone>+39 02 23903496</phone>
    <email>carlo.sposito@istitutotumori.mi.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Marco Vivarelli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ASST Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Michele Colledan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Domenico Pinelli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Enzo Andorno, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Maggiore di Milano Policlinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Giorgio Rossi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Barbara Antonelli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paolo Reggiani, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedale Niguarda Ca' Granda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Luciano De Carlis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrea Sartore Bianchi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stefano Di Sandro, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto NAzionale Tumori di Milano</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Conte</last_name>
      <phone>+39 02 23902544</phone>
      <email>andrea.conte@istitutotumori.mi.it</email>
    </contact>
    <investigator>
      <last_name>Carlo Sposito, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Filippo Pietrantonio, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vincenzo Mazzaferro, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)</name>
      <address>
        <city>Palermo</city>
        <zip>90133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Salvatore Gruttadauria, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Duilio Pagano, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alfredo Falcone, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chiara Cremolini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carlotta Antoniotti, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A.Gemelli IRCCS</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Alfonso Avolio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Universitario Molinette S. Giovanni Battista di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Renato Romagnoli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Umberto Baccarani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Umberto Tedeschi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paola Violi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amedeo Carraro, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Liver Transplant</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Metastasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03803436
org study id: INT 108/18
nct id: NCT03803436
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The COLT trial is an investigator-driven, multicenter, non-randomized, open-label,
      controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall
      survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a
      matched cohort of patients bearing the same tumor characteristics, collected during the same
      time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The study will compare survival in the population of patients enrolled in the COLT trial with the OS in the COLT-eligible population enrolled in the parallel TRIPLETE trial conducted by the GONO Group.
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: 5 years
description: Time from enrolement to either death or censoring
measure: Progression Free Survival
time frame: 5 years
description: Time from enrolement to either progression or censoring
measure: Complications rate
time frame: 90 days after liver transplant
description: Complications according to Dindo Clavien Classification
arm group label: Study arm
arm group type: Experimental
description: Liver transplant
arm group label: Parallel arm
arm group type: Active Comparator
description: Chemotherapy
intervention type: Procedure
intervention name: Liver transplant
description: Liver transplant from cadaveric donors
arm group label: Study arm
intervention type: Drug
intervention name: Chemotherapy
description: mFOLFOX
arm group label: Parallel arm
intervention type: Drug
intervention name: Chemotherapy
description: Panitumumab
arm group label: Parallel arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Vincenzo Mazzaferro, MD, PhD
role: Principal Investigator
affiliation: Fondazione IRCCS Istituto Nazionale Tumori di Milano
last name: Vincenzo Mazzaferro, MD, PhD
phone: +39 02 23902760
email: segreteria.mazzaferro@istitutotumori.mi.it
last name: Carlo Sposito, MD
phone: +39 02 23903496
email: carlo.sposito@istitutotumori.mi.it
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Liver Neoplasms
sharing ipd: No