<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/NCT03278600</url>
  </required_header>
  <id_info>
    <org_study_id>Fudan CUP-001</org_study_id>
    <nct_id>NCT03278600</nct_id>
  </id_info>
  <brief_title>Tissue-of-origin Directing Therapy in Patients With Cancer of Unknown Primary</brief_title>
  <official_title>The Value of Tissue-of-origin (ORIGIN-PanCA○R) Profiling in Predicting Primary Site and Directing Therapy in Patients With Cancer of Unknown Primary: a Prospective Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</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>
      This study is designed to evaluate the value of tissue-of-origin (ORIGIN-PanCA○R) profiling&#xD;
      in predicting primary site and directing therapy in patients with cancer of unknown primary.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">March 18, 2021</completion_date>
  <primary_completion_date type="Actual">March 18, 2021</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Tissue-of-origin test</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression free survival</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall response rate</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>biomarker analysis</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Cancer of Unknown Primary Site</condition>
  <arm_group>
    <arm_group_label>site-specific therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>standard treatments of sites of origin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard empiric chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard empiric chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>tissue-of-origin (ORIGIN-PanCA○R) profiling</intervention_name>
    <description>90-gene assay to predict the primary tumor site</description>
    <arm_group_label>site-specific therapy</arm_group_label>
    <arm_group_label>standard empiric chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  had a diagnosis of cancer of unknown primary (CUP) after a standard evaluation&#xD;
             (medical history, physical examination, blood counts, chemistry profile, chest/abdomen&#xD;
             computed tomography scans, positron emission tomography scan, and directed evaluation&#xD;
             of all symptomatic areas). Patients were required to have one of the following&#xD;
             histologies: adenocarcinoma, poorly differentiated neoplasms, poorly differentiated&#xD;
             carcinoma, squamous carcinoma. Sufficient archived biopsy tissue from a surgical or&#xD;
             core needle biopsy was required to perform the molecular profiling assay. Eastern&#xD;
             Cooperative Oncology Group performance status of 0 to 2; no previous systemic therapy;&#xD;
             measurable or evaluable disease (RECIST); and adequate organ function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  carcinoma limited to single site which can be potentially cured by surgery of&#xD;
             radiotherapy.patients with symptomatic brain metastases, active clinical severe&#xD;
             infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fudan University Cancer Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>January 21, 2022</last_update_submitted>
  <last_update_submitted_qc>January 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Xichun Hu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms, Unknown Primary</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/NCT03278600
org study id: Fudan CUP-001
nct id: NCT03278600
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to evaluate the value of tissue-of-origin (ORIGIN-PanCA○R) profiling
      in predicting primary site and directing therapy in patients with cancer of unknown primary.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Tissue-of-origin test
primary purpose: Treatment
masking: None (Open Label)
measure: progression free survival
time frame: 6 months
measure: overall response rate
time frame: 2 months
measure: overall survival
time frame: 12 months
measure: Adverse Events
time frame: 2 months
measure: biomarker analysis
time frame: 6 months
arm group label: site-specific therapy
arm group type: Experimental
description: standard treatments of sites of origin
arm group label: standard empiric chemotherapy
arm group type: Active Comparator
description: standard empiric chemotherapy
intervention type: Genetic
intervention name: tissue-of-origin (ORIGIN-PanCA○R) profiling
description: 90-gene assay to predict the primary tumor site
arm group label: site-specific therapy
arm group label: standard empiric chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Xichun Hu
investigator title: Professor
mesh term: Neoplasms, Unknown Primary
sharing ipd: No