<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/NCT02215889</url>
  </required_header>
  <id_info>
    <org_study_id>RAPID 2014</org_study_id>
    <nct_id>NCT02215889</nct_id>
  </id_info>
  <brief_title>Partial Liver Segment 2/3 Transplantation Study</brief_title>
  <official_title>A Phase I/II Clinical Trial to Evaluate the Benefit and Efficacy of Liver Resection And Partial Liver Segment 2/3 Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure&#xD;
      liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor&#xD;
      segments 2-3, the remaining liver segments of the recipient are removed. The patient will at&#xD;
      this time have only donor liver tissue in place.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">June 2028</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver transplantation</intervention_name>
    <arm_group_label>Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically verified adenocarcinoma in colon/rectum.&#xD;
&#xD;
          -  Liver metastases, not amenable to liver resection&#xD;
&#xD;
          -  No signs of extra hepatic metastatic disease or local recurrence according to PET/CT&#xD;
             scan within 4 weeks prior to the faculty meeting at the transplant unit, except&#xD;
             patients may have 1-3 resectable lung lesions all&lt;15mm.&#xD;
&#xD;
          -  No signs of extra hepatic metastatic disease on CT thorax/abdomen/pelvis within 4&#xD;
             weeks prior to the faculty meeting at the transplant unit, except patients may have&#xD;
             1-3 resectable lung lesions all&lt;15mm.&#xD;
&#xD;
          -  No local recurrence according to MR-pelvis scan in patients with rectal cancer within&#xD;
             4 weeks prior to the faculty meeting at the transplant unit&#xD;
&#xD;
          -  No signs of local recurrence judged by colonoscopy / CT colography within 12 months&#xD;
             prior to the faculty meeting at the transplant unit&#xD;
&#xD;
          -  Good performance status, ECOG 0 or 1.&#xD;
&#xD;
          -  Satisfactory blood tests: Hb &gt;10g/dl, neutrophiles &gt;1.0 (after any G-CSF), TRC &gt;75,&#xD;
             Bilirubin&lt;2 x upper normal level, ASAT,ALAT&lt;5 x upper normal level, Creatinine &lt;1.25 x&#xD;
             upper normal level. Albumin above lower normal level.&#xD;
&#xD;
          -  Signed informed consent and expected cooperation of the patients for the treatment and&#xD;
             follow up must be obtained and documented according to GCP, and national/local&#xD;
             regulations.&#xD;
&#xD;
          -  All patients should have received at least 8 weeks of chemotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight loss &gt;10% the last 6 months&#xD;
&#xD;
          -  Patient BMI &gt; 30&#xD;
&#xD;
          -  Previous diagnosed bone or CNS metastatic disease.&#xD;
&#xD;
          -  Previous diagnosed cancer mammae or malignant melanoma.&#xD;
&#xD;
          -  Palliative resection of primary CRC tumor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Magnus Smedman, MD</last_name>
    <phone>23026600</phone>
    <email>torha@ous-hf.no</email>
  </overall_contact>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0424 Oslo</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Magnus Smedman, MD</last_name>
      <phone>23026600</phone>
      <phone_ext>+47</phone_ext>
      <email>torha@ous-hf.no</email>
    </contact>
    <investigator>
      <last_name>Magnus Smedman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Magnus Smedman, MD</investigator_full_name>
    <investigator_title>M.D</investigator_title>
  </responsible_party>
  <keyword>Liver metastases</keyword>
  <keyword>Transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02215889
org study id: RAPID 2014
nct id: NCT02215889
lead sponsor: 
has dmc: No
The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure
      liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor
      segments 2-3, the remaining liver segments of the recipient are removed. The patient will at
      this time have only donor liver tissue in place.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.
time frame: 4 weeks
measure: Overall Survival
time frame: 5 years
arm group label: Surgery
arm group type: Experimental
intervention type: Procedure
intervention name: Liver transplantation
arm group label: Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Magnus Smedman, MD
phone: 23026600
email: torha@ous-hf.no
facility: 
status: Recruiting
contact: 
investigator: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Magnus Smedman, MD
investigator title: M.D
mesh term: Colorectal Neoplasms