<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/NCT01703910</url>
  </required_header>
  <id_info>
    <org_study_id>CNIO-GI-01-2012</org_study_id>
    <nct_id>NCT01703910</nct_id>
  </id_info>
  <brief_title>Study of Individualized Therapies Selection for Patients With Metastatic Colorectal Carcinoma According to the Therapeutic</brief_title>
  <official_title>Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Nacional de Investigaciones Oncologicas CARLOS III</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario de Fuenlabrada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Grupo Hospital de Madrid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Apices Soluciones S.L.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro Nacional de Investigaciones Oncologicas CARLOS III</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the feasibility of selecting personalized therapies&#xD;
      for colon cancer patients who have failed standard treatments, using a new methodology based&#xD;
      on the determination of a profile of chemosensitivity by comprehensive genetic expression&#xD;
      analysis from tumor samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a prospective, randomized study in patients with metastatic colorectal carcinoma&#xD;
      progressing after two lines of prior therapy. Patients will be randomized (1:1) to receive&#xD;
      chemotherapy as determined by its oncologist or treatment according to chemosensitivity&#xD;
      profile obtained. For obtaining the profile a histological tumor sample and a sample of&#xD;
      venous blood in a tube with heparin standard are necessary . This latter sample will be&#xD;
      processed to isolate circulating tumor cells by cell adhesion with matrix coated glass&#xD;
      spheres. The RNA from these circulating tumor cells as well as from tumor cells of tumor&#xD;
      biopsies from the same patients will be extracted by a standard procedure for extracting RNA&#xD;
      for genetic expression analysis. Based on the analysis performed on tumor biopsy is generated&#xD;
      a ranked list of potentially more effective treatments in every case&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Overall survival</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the tumor progression-free survival at 3 and 6 months (PFS3 and PFS6) in both groups of patients and identify whether there is a statistically significant difference</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gene expression profiles</measure>
    <time_frame>12 months</time_frame>
    <description>Assess the correlation between the gene expression profiles obtained from the CTC and the gene expression profiles obtained from tumor samples from the same patients.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Adenocarcinoma of Colon</condition>
  <condition>Adenocarcinoma of Rectum</condition>
  <condition>Metastatic Disease</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control treatment and will be treated with any of the schemes used in the study according to the discretion of the physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment guided by the gene expression profiles obtained from the CTC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Arm A chemotherapy</intervention_name>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>Capecitabine</other_name>
    <other_name>Cisplatin</other_name>
    <other_name>Cetuximab</other_name>
    <other_name>Doxorubicin</other_name>
    <other_name>Fluorouracil</other_name>
    <other_name>Gemcitabine</other_name>
    <other_name>Irinotecan</other_name>
    <other_name>Topotecan</other_name>
    <other_name>Mitomycin C</other_name>
    <other_name>Oxaliplatin</other_name>
    <other_name>Paclitaxel</other_name>
    <other_name>Docetaxel</other_name>
    <other_name>Pemetrexed</other_name>
    <other_name>Raltitrexed</other_name>
    <other_name>Sorafenib</other_name>
    <other_name>Erlotinib</other_name>
    <other_name>Vinorelbine</other_name>
    <other_name>Dasatinib</other_name>
    <other_name>Etoposide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>arm B chemotherapy</intervention_name>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Capecitabine</other_name>
    <other_name>Cisplatin</other_name>
    <other_name>Cetuximab</other_name>
    <other_name>Doxorubicin</other_name>
    <other_name>Fluorouracil</other_name>
    <other_name>Gemcitabine</other_name>
    <other_name>Irinotecan</other_name>
    <other_name>Topotecan</other_name>
    <other_name>Mitomycin C</other_name>
    <other_name>Oxaliplatin</other_name>
    <other_name>Paclitaxel</other_name>
    <other_name>Docetaxel</other_name>
    <other_name>Pemetrexed</other_name>
    <other_name>Raltitrexed</other_name>
    <other_name>Sorafenib</other_name>
    <other_name>Erlotinib</other_name>
    <other_name>Vinorelbine</other_name>
    <other_name>Dasatinib</other_name>
    <other_name>Etoposide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological examination showed of metastatic colon carcinoma.&#xD;
&#xD;
          -  Patients more than 18 years.&#xD;
&#xD;
          -  Measurable disease according to RECIST 1.1 criteriso&#xD;
&#xD;
          -  Life expectancymore than 3 months according to the criteria of the investigator.&#xD;
&#xD;
          -  Goodoverall condition determined by the ECOG scale (score 0-1)&#xD;
&#xD;
          -  Candidate for systemic treatment based on the profile of sensibility to drugs&#xD;
             determined by genetic analysis of the tumor sample. Patients should have received at&#xD;
             least two lines of standard treatment, including therapies antiEGFR in cases of tumors&#xD;
             with Kras oncogene B-Raf and native (non-mutated).&#xD;
&#xD;
          -  Availability of tumor tissue or potential for tumor biopsy correlation allowing the&#xD;
             RNA expression profile with that obtained from the peripheral blood CTCs.&#xD;
&#xD;
          -  Adequate hematologic function: ANCmore than 1.5 x 103 / L, platelet count absolute&#xD;
             more than 100 x 109 / L, normal values of INR and PTT.&#xD;
&#xD;
          -  Adequate liver function: total serum bilirubin no more than 2 mg / dL, ALT and AST no&#xD;
             more than 3 times the upper limit established by the laboratory (LSR) or no more than&#xD;
             5 LSR in patients with liver metastases.&#xD;
&#xD;
          -  Adequate renal function: serum creatinine no more than 1.5 LSR or calculated&#xD;
             creatinine clearance 60 ml / min (Crock).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has received systemic cancer treatment within two weeks prior to&#xD;
             extraction of the blood sample.&#xD;
&#xD;
          -  Patient has received therapeutic radioisotopes such as strontium 89 within 4 weeks&#xD;
             before blood extraction.&#xD;
&#xD;
          -  Patient has had major surgery or percutaneous procedures such as placement of central&#xD;
             venous catheter within 2 weeks prior to the blood draw.&#xD;
&#xD;
          -  Patient has a history as bone marrow transplantation and / or stem cell&#xD;
             transplantation.&#xD;
&#xD;
          -  Patient has any of the following concomitant diseases or current conditions:&#xD;
&#xD;
        chronic active liver disease of any origin, and / or cirrhosis with Child-Pugh score B or&#xD;
        C.&#xD;
&#xD;
        Uncontrolled active infection. carries the human immunodeficiency virus (HIV). Any other&#xD;
        significant disease that in the opinion of the investigator, substantially increase the&#xD;
        risk associated with patient participation in this study.&#xD;
&#xD;
        documented symptomatic brain metastases, progression or requiring corticosteroids or&#xD;
        associated to a leptomeningeal involvement.&#xD;
&#xD;
        Patients with uncontrolled systemic diseases. Patients with Hypertension or Diabetes&#xD;
        Mellitus is countable if at the time of inclusion deemed medically controlled.&#xD;
&#xD;
        Patients with inability for oral drug delivery, either by preventing gastrointestinal&#xD;
        administration situation or severe impairment of intestinal absorption&#xD;
&#xD;
          -  Any medical or psychiatric condition that, in the opinion of the investigator, may&#xD;
             limit the patient's ability to understand and fulfill all requirements under its&#xD;
             partcipación in the study.&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Gómez, M.D.,Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Centro Nacional de Investigaciones Oncológicas (CNIO)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario de Fuenlabrada</name>
      <address>
        <city>Fuenlabrada</city>
        <state>Madrid</state>
        <zip>28950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Madrid Norte Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 8, 2015</last_update_submitted>
  <last_update_submitted_qc>October 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Genomic expression profile in tumor samples</keyword>
  <keyword>Adult patients</keyword>
  <keyword>metastatic disease status and progression after two lines of systemic therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Vinorelbine</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Etoposide phosphate</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Cetuximab</mesh_term>
    <mesh_term>Erlotinib Hydrochloride</mesh_term>
    <mesh_term>Sorafenib</mesh_term>
    <mesh_term>Topotecan</mesh_term>
    <mesh_term>Dasatinib</mesh_term>
    <mesh_term>Mitomycins</mesh_term>
    <mesh_term>Mitomycin</mesh_term>
    <mesh_term>Raltitrexed</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/NCT01703910
org study id: CNIO-GI-01-2012
nct id: NCT01703910
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to assess the feasibility of selecting personalized therapies
      for colon cancer patients who have failed standard treatments, using a new methodology based
      on the determination of a profile of chemosensitivity by comprehensive genetic expression
      analysis from tumor samples.
It is a prospective, randomized study in patients with metastatic colorectal carcinoma
      progressing after two lines of prior therapy. Patients will be randomized (1:1) to receive
      chemotherapy as determined by its oncologist or treatment according to chemosensitivity
      profile obtained. For obtaining the profile a histological tumor sample and a sample of
      venous blood in a tube with heparin standard are necessary . This latter sample will be
      processed to isolate circulating tumor cells by cell adhesion with matrix coated glass
      spheres. The RNA from these circulating tumor cells as well as from tumor cells of tumor
      biopsies from the same patients will be extracted by a standard procedure for extracting RNA
      for genetic expression analysis. Based on the analysis performed on tumor biopsy is generated
      a ranked list of potentially more effective treatments in every case
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 12 months
description: To determine the tumor progression-free survival at 3 and 6 months (PFS3 and PFS6) in both groups of patients and identify whether there is a statistically significant difference
measure: gene expression profiles
time frame: 12 months
description: Assess the correlation between the gene expression profiles obtained from the CTC and the gene expression profiles obtained from tumor samples from the same patients.
arm group label: Arm A
arm group type: Active Comparator
description: Control treatment and will be treated with any of the schemes used in the study according to the discretion of the physician.
arm group label: Arm B
arm group type: Experimental
description: Treatment guided by the gene expression profiles obtained from the CTC
intervention type: Drug
intervention name: Arm A chemotherapy
arm group label: Arm A
other name: Capecitabine
other name: Cisplatin
other name: Cetuximab
other name: Doxorubicin
other name: Fluorouracil
other name: Gemcitabine
other name: Irinotecan
other name: Topotecan
other name: Mitomycin C
other name: Oxaliplatin
other name: Paclitaxel
other name: Docetaxel
other name: Pemetrexed
other name: Raltitrexed
other name: Sorafenib
other name: Erlotinib
other name: Vinorelbine
other name: Dasatinib
other name: Etoposide
intervention type: Drug
intervention name: arm B chemotherapy
arm group label: Arm B
other name: Capecitabine
other name: Cisplatin
other name: Cetuximab
other name: Doxorubicin
other name: Fluorouracil
other name: Gemcitabine
other name: Irinotecan
other name: Topotecan
other name: Mitomycin C
other name: Oxaliplatin
other name: Paclitaxel
other name: Docetaxel
other name: Pemetrexed
other name: Raltitrexed
other name: Sorafenib
other name: Erlotinib
other name: Vinorelbine
other name: Dasatinib
other name: Etoposide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 76 Years
healthy volunteers: No
last name: Carlos Gómez, M.D.,Ph.D
role: Study Director
affiliation: Centro Nacional de Investigaciones Oncológicas (CNIO)
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Colorectal Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Paclitaxel
mesh term: Etoposide
mesh term: Vinorelbine
mesh term: Docetaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Cisplatin
mesh term: Gemcitabine
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Fluorouracil
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Irinotecan
mesh term: Etoposide phosphate
mesh term: Pemetrexed
mesh term: Cetuximab
mesh term: Erlotinib Hydrochloride
mesh term: Sorafenib
mesh term: Topotecan
mesh term: Dasatinib
mesh term: Mitomycins
mesh term: Mitomycin
mesh term: Raltitrexed