<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/NCT03251612</url>
  </required_header>
  <id_info>
    <org_study_id>Tumorspheres Colrec</org_study_id>
    <nct_id>NCT03251612</nct_id>
  </id_info>
  <brief_title>Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer</brief_title>
  <official_title>Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vejle Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vejle Hospital</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>
      The purpose of the present study is to investigate the benefit of anti-cancer therapy&#xD;
      administered on the basis of drug sensitivity testing. This concerns colorectal cancer&#xD;
      patients who have previously received standard treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">March 21, 2022</completion_date>
  <primary_completion_date type="Actual">August 23, 2021</primary_completion_date>
  <phase>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>Progression free survival 8 weeks after start of treatment</measure>
    <time_frame>42-63 days after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Every 8 weeks until progression or death up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Every 3 months up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>Every 8 weeks until progression up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as measured by questionnaire EQ-5D-5L</measure>
    <time_frame>Every 8 weeks up to 2.5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Colorectal Cancer Metastatic</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Based on sensitivity analysis</intervention_name>
    <description>5FU, infusional&#xD;
Capecitabine&#xD;
Oxaliplatin (FOLFOX)&#xD;
Irinotecan (FOLFIRI)&#xD;
FOLFOXIRI (triplet)&#xD;
Bevacizumab&#xD;
Panitumumab&#xD;
Cetuximab&#xD;
Regorafenib&#xD;
Tas-102&#xD;
Ramucirumab&#xD;
Aflibercept&#xD;
Pembrolizumab&#xD;
Nivolumab&#xD;
Vinorelbine and capecitabine&#xD;
Sorafenib&#xD;
Gemcitabine and capecitabine&#xD;
Olaparib&#xD;
Epirubicin</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastatic colorectal cancer&#xD;
&#xD;
               -  Biopsy proven adenocarcinoma compatible with colorectal origin (primary tumor or&#xD;
                  metastasis)&#xD;
&#xD;
               -  If only biopsy from metastasis can be obtained, the patient must have a&#xD;
                  previously resected or image proven tumor of the colon or rectum (scanning or&#xD;
                  endoscopy)&#xD;
&#xD;
               -  Non-resectable metastatic spread&#xD;
&#xD;
          -  Previously exposed to or intolerance or contraindications to standard systemic&#xD;
             therapy, defined as&#xD;
&#xD;
               -  oxaliplatin&#xD;
&#xD;
               -  irinotecan&#xD;
&#xD;
               -  5-fluorouracil (or similar such as capecitabine, S1)&#xD;
&#xD;
               -  VEGF inhibitor bevacizumab&#xD;
&#xD;
               -  EGFR inhibitor panitumumab or cetuximab (if RAS/RAF wt)&#xD;
&#xD;
          -  Progressive disease defined as progression according to RECIST 1.1&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
          -  Adequate bone marrow, liver and renal function allowing systemic chemotherapy&#xD;
&#xD;
               -  Absolute neutrophil count ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/l.&#xD;
&#xD;
               -  Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper&#xD;
                  normal value&#xD;
&#xD;
               -  Calculated or measured renal glomerular filtration rate at least 30 mL/min&#xD;
&#xD;
          -  Anticonception for fertile women and for male patients with a fertile partner.&#xD;
             Intrauterine device, vasectomy of a female subject's male partner or hormonal&#xD;
             contraceptive are acceptable&#xD;
&#xD;
          -  Written and orally informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incapacity, frailty, disability, or comorbidity to a degree that according to the&#xD;
             investigator is not compatible with participation in the protocol&#xD;
&#xD;
          -  Other active malignant disease requiring therapy&#xD;
&#xD;
          -  Other systemic anti-cancer therapy (palliative radiotherapy is allowed).&#xD;
&#xD;
          -  Pregnant (positive pregnancy test) or breast feeding women&#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>Lars H Jensen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Vejle Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oncology, Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Oncology, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departmen of Oncology, Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 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>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/NCT03251612
org study id: Tumorspheres Colrec
nct id: NCT03251612
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the present study is to investigate the benefit of anti-cancer therapy
      administered on the basis of drug sensitivity testing. This concerns colorectal cancer
      patients who have previously received standard treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival 8 weeks after start of treatment
time frame: 42-63 days after start of treatment
measure: Progression free survival
time frame: Every 8 weeks until progression or death up to 2.5 years
measure: Overall survival
time frame: Every 3 months up to 2.5 years
measure: Response rate
time frame: Every 8 weeks until progression up to 2.5 years
measure: Quality of life as measured by questionnaire EQ-5D-5L
time frame: Every 8 weeks up to 2.5 years
arm group label: Treatment
arm group type: Other
description: 1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.
intervention type: Drug
intervention name: Based on sensitivity analysis
description: 5FU, infusional
Capecitabine
Oxaliplatin (FOLFOX)
Irinotecan (FOLFIRI)
FOLFOXIRI (triplet)
Bevacizumab
Panitumumab
Cetuximab
Regorafenib
Tas-102
Ramucirumab
Aflibercept
Pembrolizumab
Nivolumab
Vinorelbine and capecitabine
Sorafenib
Gemcitabine and capecitabine
Olaparib
Epirubicin
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars H Jensen, MD
role: Study Chair
affiliation: Vejle Hospital
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Germany
responsible party type: Sponsor
mesh term: Colorectal Neoplasms