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/NCT05987176</url>
    </required_header>
    <id_info>
      <org_study_id>AF-ICL 01</org_study_id>
      <nct_id>NCT05987176</nct_id>
    </id_info>
    <brief_title>Comparing Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases</brief_title>
    <acronym>NELMAS</acronym>
    <official_title>An International Multi-centre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase II Study Comparing Adjuvant Treatment With 177Lu-DOTATATE (Lutathera®) to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imperial College London</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        An international multi-centre, stratified, open, randomized, comparator-controlled,&#xD;
        parallel-group phase II study comparing adjuvant treatment with 177Lu-DOTATATE to best&#xD;
        supportive care in patients after resection of neuroendocrine liver metastases.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2028</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Disease Free Survival</measure>
      <time_frame>5 years</time_frame>
      <description>To compare overall Disease-Free Survival (DFS) at 3 years after treatment with 177Lu-DOTATATE to best supportive care in patients with R0/R1 resected liver metastases of well differentiated (grade 1 or 2) GEP NET and no extrahepatic disease manifestation prior to randomization in the study.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Neuroendocrine Tumors</condition>
    <arm_group>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control arm as per standard of care patients go on routine follow up post surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment with Lutathera post surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lutathera</intervention_name>
      <description>Dosage:&#xD;
  In total 14.8 GBq (400 mCi) 177Lu-DOTATATE administered in two equally divided doses. Each dose to be infused over 30 minutes.&#xD;
  Duration of treatment:&#xD;
  Two administrations of 177Lu-DOTATATE (each treatment 7.4 GBQ (200 mCi) at 8±1-week intervals, which can be extended to 16 weeks for resolving acute toxicity.</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent prior to any study related procedures&#xD;
  &#xD;
            2. Patients aged 18 years or older&#xD;
  &#xD;
            3. ECOG / WHO performance status 0 or 1&#xD;
  &#xD;
            4. Patients with well differentiated grade 1 or grade 2 (Ki67&lt;20%) GEP NET confirmed by&#xD;
               histological criteria with the primary localisation in stomach, pancreas, or gut&#xD;
  &#xD;
            5. Patients after R0 (complete macroscopic and microscopic resection) or R1 (complete&#xD;
               macroscopic resection, microscopically positive resection margins) resection of&#xD;
               neuroendocrine liver metastases confirmed by histological criteria&#xD;
  &#xD;
            6. Patients with a primary tumour already resected or in whom the primary tumour has been&#xD;
               resected synchronously with liver metastases&#xD;
  &#xD;
            7. MRI scan prior to surgery (within 4 -6 weeks) confirming liver metastases and no&#xD;
               extrahepatic disease (except resectable perihilar lymph node involvement and/or&#xD;
               primary tumour, if still in place)&#xD;
  &#xD;
            8. Somatostatin receptor-based imaging (68Ga DOTA-TATE PET/CT prior to surgery (within 12&#xD;
               weeks) confirming liver metastases and no extrahepatic disease (except resectable&#xD;
               perihilar lymph node involvement and/or primary tumour, if still in place)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Less than 4 weeks post-surgery, or any other medical treatment, including&#xD;
               chemotherapy, radiotherapy, and intrahepatic therapy&#xD;
  &#xD;
            2. High grade neuroendocrine tumours (G3 NET, or neuroendocrine carcinoma [NEC])&#xD;
  &#xD;
            3. After R2 (tumour debulking, macroscopically incomplete resection) resection of&#xD;
               neuroendocrine liver metastases&#xD;
  &#xD;
            4. Patients with non-resectable neuroendocrine liver metastases and/or non-resectable&#xD;
               primary tumour and /or non-resectable perihilar lymph node metastases&#xD;
  &#xD;
            5. Pregnancy&#xD;
  &#xD;
            6. Subjects of childbearing potential (both male and female participants) not willing to&#xD;
               use a combination of adequate contraceptive measures, e.g., oral contraceptives, IUD,&#xD;
               barrier methods of contraception (condom or occlusive cap with spermicide)&#xD;
  &#xD;
            7. Patients who have received prior systemic and/or liver-directed treatment for their&#xD;
               metastatic NET other than somatostatin analogues&#xD;
  &#xD;
            8. Hb concentration &lt;5.0 mmol/L (&lt;8.0 g/dL)&#xD;
  &#xD;
            9. WBC &lt;2x109/L (2000/mm3)&#xD;
  &#xD;
           10. Platelets &lt;75x109/L (75x103/mm3).&#xD;
  &#xD;
           11. Total bilirubin &gt;3 x ULN.&#xD;
  &#xD;
           12. Serum albumin &lt;3.0 g/dL unless prothrombin time is within the normal range.&#xD;
  &#xD;
           13. Uncontrolled congestive heart failure (NYHA II, III, IV).&#xD;
  &#xD;
           14. Uncontrolled diabetes mellitus as defined by a fasting blood glucose &gt;2 ULN.&#xD;
  &#xD;
           15. Prior external beam radiation therapy to more than 25% of the bone marrow.&#xD;
  &#xD;
           16. Kidney failure with serum creatinine &gt;150 µmol/L (&gt;1.7 mg/dL)&#xD;
  &#xD;
           17. Known hypersensitivity to somatostatin analogues&#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>Chynna Pascual</last_name>
      <phone>02033133170</phone>
      <email>nelmas-trial@imperial.ac.uk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neuroendocrine Tumors</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lutetium Lu 177 dotatate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05987176
  org study id: AF-ICL 01
  nct id: NCT05987176
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  An international multi-centre, stratified, open, randomized, comparator-controlled,
        parallel-group phase II study comparing adjuvant treatment with 177Lu-DOTATATE to best
        supportive care in patients after resection of neuroendocrine liver metastases.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Disease Free Survival
  time frame: 5 years
  description: To compare overall Disease-Free Survival (DFS) at 3 years after treatment with 177Lu-DOTATATE to best supportive care in patients with R0/R1 resected liver metastases of well differentiated (grade 1 or 2) GEP NET and no extrahepatic disease manifestation prior to randomization in the study.
  arm group label: Standard of Care
  arm group type: No Intervention
  description: Control arm as per standard of care patients go on routine follow up post surgery.
  arm group label: Treatment
  arm group type: Experimental
  description: Treatment with Lutathera post surgery.
  intervention type: Drug
  intervention name: Lutathera
  description: Dosage:
  In total 14.8 GBq (400 mCi) 177Lu-DOTATATE administered in two equally divided doses. Each dose to be infused over 30 minutes.
  Duration of treatment:
  Two administrations of 177Lu-DOTATATE (each treatment 7.4 GBQ (200 mCi) at 8±1-week intervals, which can be extended to 16 weeks for resolving acute toxicity.
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Chynna Pascual
  phone: 02033133170
  email: nelmas-trial@imperial.ac.uk
  responsible party type: Sponsor
  mesh term: Neuroendocrine Tumors
  mesh term: Lutetium Lu 177 dotatate
  sharing ipd: No