<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/NCT02236910</url>
  </required_header>
  <id_info>
    <org_study_id>TX-LUT-001-London</org_study_id>
    <secondary_id>Lu-DOTA-TATE</secondary_id>
    <nct_id>NCT02236910</nct_id>
  </id_info>
  <brief_title>An Open Label Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours</brief_title>
  <official_title>An Open Label Phase II, Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as&#xD;
      being effective in controlling symptoms and increase quality of life; induce stable disease&#xD;
      and extend progression free survival; induce a (good) partial remission and induce a complete&#xD;
      remission in patients with a somatostatin receptor positive tumour.&#xD;
&#xD;
      The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression&#xD;
      free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE,&#xD;
      and the quality of life of the patients treated with Lu-DOTA-TATE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neuroendocrine (NET) tumours have secretory and metabolic pathways not typically found in&#xD;
      other cancers that can be utilized for molecular imaging and therapeutic targeting. The most&#xD;
      important is somatostatin. Somatostatin receptors are useful tools in the diagnosis and&#xD;
      treatment of NET tumours because the somatostatin analogue octreotate can be radiolabeled&#xD;
      with lutetium-177 for imaging and therapy.&#xD;
&#xD;
      In selected populations of patients, radioisotope therapy in expert hands has been shown to&#xD;
      be a safe and effective palliative therapy with stable disease, progression free survival&#xD;
      benefit, symptom control and improvements in quality of life. Lutetium-177 (DOTA0, Tyr3)&#xD;
      octreotate has been used in a significant number of clinical studies shown to be safe and&#xD;
      effective as a therapeutic agent in patients with NET tumours. The investigators intend to&#xD;
      further confirm these benefits with lutetium-177 octreotate, which could form the basis for a&#xD;
      national registry study leading to registration of this therapeutic intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumour response measured by RECIST criteria</measure>
    <time_frame>7 years (end of study)</time_frame>
    <description>Target lesions will be assigned after treatment 1 base done either the Lu-177 scan, or the CT/MRI scan within 2 weeks prior to treatment 1. Tumour response will be measured using response evaluation criteria in solid tumours (RECIST).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>7 years (end of study)</time_frame>
    <description>Progression free survival will be measured from the date of enrollment to the date the target lesion progresses as per RECIST criteria, or death sue to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>7 years (end of study)</time_frame>
    <description>Quality of life changes due to treatment with Lu-DOTA-TATE, measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire(QLQ) EORTC QLQ-C30.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Neuroendocrine Carcinoma</condition>
  <arm_group>
    <arm_group_label>Primary Therapy with Lu-DOTA-TATE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lu-DOTA-TATE (Lutetium-177 Octreotate) will be administered by intravenous infusion to participants who have not been previously treated with Lu-DOTA-TATE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary Therapy with Lu-DOTA-TATE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who have received previous treatment with Lu-DOTA-TATE (Lutetium-177 Octreotate) under the special access program are eligible to be treated in this study. Patients will receive Lu-DOTA-TATE by intravenous infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lu-DOTA-TATE</intervention_name>
    <arm_group_label>Primary Therapy with Lu-DOTA-TATE</arm_group_label>
    <arm_group_label>Secondary Therapy with Lu-DOTA-TATE</arm_group_label>
    <other_name>Lutetium-177 Octreotate</other_name>
    <other_name>radiopharmaceutical</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group A: Primary therapy subjects will be included in the study if they meet all of the&#xD;
        following general criteria:&#xD;
&#xD;
          1. Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and&#xD;
             outside of the window of 10 days since the first day of the last menstrual period, a&#xD;
             negative pregnancy test is required.&#xD;
&#xD;
          2. Presence of somatostatin receptor positive tumour(s) (either histologically or&#xD;
             Octreoscan image proven), with at least 1 tumour site reliably evaluable by CT or MRI&#xD;
             of at least 1.5 cm (smallest dimension) with respect to RECIST criteria (the target&#xD;
             lesion).&#xD;
&#xD;
          3. Presence of somatostatin receptors on (at least) the target lesion demonstrated by&#xD;
             uptake of OctreoScan® at least equal to liver uptake within 12 weeks of enrollment.&#xD;
&#xD;
          4. Life expectancy greater than 26 weeks from enrollment.&#xD;
&#xD;
          5. Serum creatinine ≤ 130 μmol/L, and a measured glomerular filtration rate (GFR) using&#xD;
             plasma clearance of ≥50 mL/min measured within 2 weeks of enrollment.&#xD;
&#xD;
          6. Haemoglobin concentration ≥ 90 g/L; white blood cell count (WBC) ≥ 3 x 109/L;&#xD;
             platelets ≥ 100 x 109/L measured within 2 weeks of enrollment.&#xD;
&#xD;
          7. Liver function tests (serum albumin, total bilirubin, alanine amniotransferase&#xD;
             (ALT),aspartate aminotransferase (AST) and alkaline phosphatase) ≤ 3 X the limit of&#xD;
             normal.&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within&#xD;
             2 weeks of enrollment.&#xD;
&#xD;
          9. Provide written informed consent prior to enrollment.&#xD;
&#xD;
         10. Ki 67 &lt; 20%, unless patients has been treated with chemotherapy and lesions are stable&#xD;
             (Ki 67 &lt; 30%)&#xD;
&#xD;
        Group B: Secondary therapy subjects will be included in the study if they meet all of the&#xD;
        following general criteria:&#xD;
&#xD;
          1. Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and&#xD;
             outside of the window of 10 days since the first day of the last menstrual period, a&#xD;
             negative pregnancy test is required.&#xD;
&#xD;
          2. Have received Lu-DOTA-TATE treatment at the London Health Sciences Centre under the&#xD;
             Special Access Programed or other radionuclide therapy for neuroendocrine tumor.&#xD;
&#xD;
          3. Provide written informed consent prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Group A: Primary therapy subjects will be excluded from the study if they meet any of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Potential for surgery with curative intent. Local surgery for symptomatic relief&#xD;
             permitted as long as target lesion unaffected.&#xD;
&#xD;
          2. Surgery, radiation therapy, radioisotope therapy, change in Sandostatin LAR therapy&#xD;
             dosage, cytotoxic chemotherapy, embolization or other investigative therapy&#xD;
             [interferons, mammalian target of rapamycin (mTOR) inhibitors] within 12 weeks of&#xD;
             enrollment. Localized external beam irradiation permitted as long as target lesion&#xD;
             unaffected.&#xD;
&#xD;
          3. Known brain metastases unless these metastases have been treated or stable (confirmed&#xD;
             by CT) for ≥ 6 months prior to enrollment&#xD;
&#xD;
          4. Uncontrolled diabetes mellitus defined as fasting glucose ≥ 3 X the upper limit of&#xD;
             normal within 12 weeks of enrollment.&#xD;
&#xD;
          5. Another significant medical, psychiatric or surgical condition uncontrolled by&#xD;
             treatment, which may interfere with completion or conduct of the study (such as&#xD;
             urinary incontinence, co-existing malignancies).&#xD;
&#xD;
          6. Pregnancy.&#xD;
&#xD;
          7. Breast feeding.&#xD;
&#xD;
          8. Prior radiation therapy to more than 25% of the bone marrow.&#xD;
&#xD;
        Group B: Secondary therapy subjects will be excluded from the study if they meet any of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Another significant medical, psychiatric or surgical condition uncontrolled by&#xD;
             treatment, which may interfere with completion or conduct of the study (such as&#xD;
             urinary incontinence, co-existing malignancies).&#xD;
&#xD;
          2. Pregnancy.&#xD;
&#xD;
          3. Breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>david laidley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre &amp; Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>somatostatin receptor positive tumour</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Neuroendocrine</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiopharmaceuticals</mesh_term>
    <mesh_term>Lutetium Lu 177 dotatate</mesh_term>
  </intervention_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/NCT02236910
org study id: TX-LUT-001-London
secondary id: Lu-DOTA-TATE
nct id: NCT02236910
lead sponsor: 
has dmc: No
Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as
      being effective in controlling symptoms and increase quality of life; induce stable disease
      and extend progression free survival; induce a (good) partial remission and induce a complete
      remission in patients with a somatostatin receptor positive tumour.

      The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression
      free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE,
      and the quality of life of the patients treated with Lu-DOTA-TATE.
Neuroendocrine (NET) tumours have secretory and metabolic pathways not typically found in
      other cancers that can be utilized for molecular imaging and therapeutic targeting. The most
      important is somatostatin. Somatostatin receptors are useful tools in the diagnosis and
      treatment of NET tumours because the somatostatin analogue octreotate can be radiolabeled
      with lutetium-177 for imaging and therapy.

      In selected populations of patients, radioisotope therapy in expert hands has been shown to
      be a safe and effective palliative therapy with stable disease, progression free survival
      benefit, symptom control and improvements in quality of life. Lutetium-177 (DOTA0, Tyr3)
      octreotate has been used in a significant number of clinical studies shown to be safe and
      effective as a therapeutic agent in patients with NET tumours. The investigators intend to
      further confirm these benefits with lutetium-177 octreotate, which could form the basis for a
      national registry study leading to registration of this therapeutic intervention.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumour response measured by RECIST criteria
time frame: 7 years (end of study)
description: Target lesions will be assigned after treatment 1 base done either the Lu-177 scan, or the CT/MRI scan within 2 weeks prior to treatment 1. Tumour response will be measured using response evaluation criteria in solid tumours (RECIST).
measure: Progression Free Survival
time frame: 7 years (end of study)
description: Progression free survival will be measured from the date of enrollment to the date the target lesion progresses as per RECIST criteria, or death sue to any cause.
measure: Quality of Life
time frame: 7 years (end of study)
description: Quality of life changes due to treatment with Lu-DOTA-TATE, measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire(QLQ) EORTC QLQ-C30.
arm group label: Primary Therapy with Lu-DOTA-TATE
arm group type: Experimental
description: Lu-DOTA-TATE (Lutetium-177 Octreotate) will be administered by intravenous infusion to participants who have not been previously treated with Lu-DOTA-TATE
arm group label: Secondary Therapy with Lu-DOTA-TATE
arm group type: Experimental
description: Patients who have received previous treatment with Lu-DOTA-TATE (Lutetium-177 Octreotate) under the special access program are eligible to be treated in this study. Patients will receive Lu-DOTA-TATE by intravenous infusion.
intervention type: Other
intervention name: Lu-DOTA-TATE
arm group label: Primary Therapy with Lu-DOTA-TATE
arm group label: Secondary Therapy with Lu-DOTA-TATE
other name: Lutetium-177 Octreotate
other name: radiopharmaceutical
criteria: 
gender: All
minimum age: 14 Years
maximum age: 90 Years
healthy volunteers: No
last name: david laidley, MD
role: Principal Investigator
affiliation: London Health Sciences Centre & Lawson Health Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Carcinoma, Neuroendocrine
mesh term: Radiopharmaceuticals
mesh term: Lutetium Lu 177 dotatate