<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/NCT03289741</url>
  </required_header>
  <id_info>
    <org_study_id>17-422</org_study_id>
    <nct_id>NCT03289741</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide</brief_title>
  <official_title>A Pilot Study To Evaluate Patient Experience With the Somatostatin Analogs Octreotide Long Acting Release and Lanreotide During the Treatment of Advanced, Nonfunctional, Well Differentiated Neuroendocrine Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</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>
      This study is being done to evaluate differences in patient experience during treatment with&#xD;
      octreotide LAR and lanreotide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">April 10, 2023</completion_date>
  <primary_completion_date type="Actual">April 10, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Two-arm randomized design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of mean pain scores</measure>
    <time_frame>2 years</time_frame>
    <description>Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain&quot; to 10 being &quot;Worst pain ever&quot; the pain or discomfort experienced with the SSA injection.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <arm_group>
    <arm_group_label>Octreotide then Lanreotide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lanreotide then Octreotide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octreotide</intervention_name>
    <description>Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections</description>
    <arm_group_label>Lanreotide then Octreotide</arm_group_label>
    <arm_group_label>Octreotide then Lanreotide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LAR Lanreotide</intervention_name>
    <description>Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections</description>
    <arm_group_label>Lanreotide then Octreotide</arm_group_label>
    <arm_group_label>Octreotide then Lanreotide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.</description>
    <arm_group_label>Lanreotide then Octreotide</arm_group_label>
    <arm_group_label>Octreotide then Lanreotide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent for the trial&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Histologically- or cytologically- confirmed locally advanced or metastatic WDNET&#xD;
&#xD;
          -  SSA therapy is recommended by physician for disease management, and has not yet begun&#xD;
&#xD;
          -  ECOG performance status of 0, 1, or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently participating in a study of an investigational agent&#xD;
&#xD;
          -  Prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day&#xD;
             1 or not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a&#xD;
             previously administered agent&#xD;
&#xD;
             *Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to&#xD;
             this criterion and may qualify for the study&#xD;
&#xD;
          -  No concurrent chemotherapy or targeted small molecule therapy&#xD;
&#xD;
          -  If received major surgery, not recovered adequately from the toxicity and/or&#xD;
             complications from the intervention prior to starting the study&#xD;
&#xD;
          -  Known additional malignancy that is progressing or requires active treatment&#xD;
&#xD;
          -  Active infection requiring systemic therapy&#xD;
&#xD;
          -  Known psychiatric or substance abuse disorders that would interfere with cooperation&#xD;
             with the requirements of the trial&#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_official>
    <last_name>Nitya Raj, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering West Harrison</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Octreotide</keyword>
  <keyword>Lanreotide</keyword>
  <keyword>17-422</keyword>
  <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>Octreotide</mesh_term>
    <mesh_term>Lanreotide</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/NCT03289741
org study id: 17-422
nct id: NCT03289741
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study is being done to evaluate differences in patient experience during treatment with
      octreotide LAR and lanreotide.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Two-arm randomized design
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of mean pain scores
time frame: 2 years
description: Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain" to 10 being "Worst pain ever" the pain or discomfort experienced with the SSA injection.
arm group label: Octreotide then Lanreotide
arm group type: Experimental
description: Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
arm group label: Lanreotide then Octreotide
arm group type: Experimental
description: Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
intervention type: Drug
intervention name: Octreotide
description: Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections
arm group label: Lanreotide then Octreotide
arm group label: Octreotide then Lanreotide
intervention type: Drug
intervention name: LAR Lanreotide
description: Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
arm group label: Lanreotide then Octreotide
arm group label: Octreotide then Lanreotide
intervention type: Behavioral
intervention name: Questionnaires
description: Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.
arm group label: Lanreotide then Octreotide
arm group label: Octreotide then Lanreotide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nitya Raj, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors
mesh term: Octreotide
mesh term: Lanreotide