<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/NCT04425564</url>
  </required_header>
  <id_info>
    <org_study_id>201516007.3</org_study_id>
    <nct_id>NCT04425564</nct_id>
  </id_info>
  <brief_title>Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients</brief_title>
  <official_title>Clinico-pharmacological Study of Metronomic Capecitabine and Oxaliplatin Versus Classic XELOX in Egyptian Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute, Egypt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer (CRC) in Egypt is advanced tumors at diagnosis. Although, the dramatic&#xD;
      increase in efficacy, reduction of mortality, and improvements in survival by the use of&#xD;
      standard doses of chemotherapy, some CRC patients suffer from severe toxicities besides&#xD;
      disease progression. Use of chemotherapy less than the maximum tolerated dose, with no&#xD;
      prolonged drug free breaks incapacitates the cells to engage in progression mechanisms,&#xD;
      suggesting that it could be a better alternative to standard dose therapy with better&#xD;
      toxicity profile&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized phase II prospective study that included 70 (35 in each arm) metastatic&#xD;
      Egyptian CRC cancer patients diagnosed at the National Cancer Institute, Cairo University&#xD;
      between January 2016 and June 2018). Patients were randomly treated with either classic XELOX&#xD;
      (arm A) or with capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg/m2 weekly X 8&#xD;
      weeks) then 2 weeks rest (arm B). Toxicities and the survival analysis after two years for&#xD;
      both regimens were recorded. Blood samples are taken from both groups to assess&#xD;
      pharmacokinetics of capecitabine and its relation to dosing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response rates</measure>
    <time_frame>two years</time_frame>
    <description>Calculated with 95% confidence interval</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of toxicities and grades</measure>
    <time_frame>two years</time_frame>
    <description>Categorical data summarized by pecentages</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak and trough levels of capecitabine and relation to dosing</measure>
    <time_frame>Two years</time_frame>
    <description>Numerical data summarized by means and standard deviation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>two years</time_frame>
    <description>Cox proportional hazard model</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Two years</time_frame>
    <description>Kaplan and Meier test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Clinical Response</condition>
  <condition>Toxicity</condition>
  <condition>Survival</condition>
  <arm_group>
    <arm_group_label>Classic (A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients recieving classic XELOX (oxaliplatin 130mg/m2 and capecitabine 1000mg/m2 bid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metronomic (B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients recieving low dose capecitabine (2000mg daily divided in two doses for 8 weeks) and oxaliplatin (30mg/m2 weekly for eight weeks) followed by 2 weeks rest.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metronomic XELOX</intervention_name>
    <arm_group_label>metronomic (B)</arm_group_label>
    <other_name>Capecitabine</other_name>
    <other_name>Oxaliplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Classic XELOX</intervention_name>
    <arm_group_label>Classic (A)</arm_group_label>
    <other_name>Capecitabine</other_name>
    <other_name>Oxaliplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood samples for pharmacological studies</intervention_name>
    <arm_group_label>Classic (A)</arm_group_label>
    <arm_group_label>metronomic (B)</arm_group_label>
    <other_name>No other names</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient age 18-70 years of both sexes.&#xD;
&#xD;
          -  PS 0-2 and histologically proven mCRC with unresectable metastases (rectal cancer is&#xD;
             included to left side cancers).&#xD;
&#xD;
          -  They should have measurable lesions (that can be accurately measured in at least one&#xD;
             dimension using calipers or ruler and measurement must be at least 20 mm using&#xD;
             conventional techniques or 10 mm using spiral CT scan).&#xD;
&#xD;
          -  No previous treatment for metastatic disease and had ended adjuvant treatment &gt; 6&#xD;
             months.&#xD;
&#xD;
          -  peripheral neuritis less than grade 2.&#xD;
&#xD;
          -  Normal organ functions:(Creatinine ≤1.2, Bilirubin ≤1.2, SGOT/SGPT&lt; 2N, HB &gt;9gm/dl,&#xD;
             WBC&gt;3.5/dl with ANC &gt;1.5/dl, Plat ≥100/dl).&#xD;
&#xD;
          -  For patients with liver metastases, Bilirubin should not be &gt;2.5N and transaminases&#xD;
             not &gt;5N. (All patients were screened for HCV and HBS Ag by PCR).&#xD;
&#xD;
          -  Adequate cardiac functions (EF&gt;55%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with only ascites or bone metastasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colorectal cancer</keyword>
  <keyword>metronomic capecitabine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 17, 2020</submitted>
    <returned>October 9, 2020</returned>
    <submitted>March 9, 2021</submitted>
    <returned>April 2, 2021</returned>
  </pending_results>
  <!-- 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/NCT04425564
org study id: 201516007.3
nct id: NCT04425564
lead sponsor: 
has dmc: Yes
Colorectal cancer (CRC) in Egypt is advanced tumors at diagnosis. Although, the dramatic
      increase in efficacy, reduction of mortality, and improvements in survival by the use of
      standard doses of chemotherapy, some CRC patients suffer from severe toxicities besides
      disease progression. Use of chemotherapy less than the maximum tolerated dose, with no
      prolonged drug free breaks incapacitates the cells to engage in progression mechanisms,
      suggesting that it could be a better alternative to standard dose therapy with better
      toxicity profile
This is a randomized phase II prospective study that included 70 (35 in each arm) metastatic
      Egyptian CRC cancer patients diagnosed at the National Cancer Institute, Cairo University
      between January 2016 and June 2018). Patients were randomly treated with either classic XELOX
      (arm A) or with capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg/m2 weekly X 8
      weeks) then 2 weeks rest (arm B). Toxicities and the survival analysis after two years for
      both regimens were recorded. Blood samples are taken from both groups to assess
      pharmacokinetics of capecitabine and its relation to dosing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: response rates
time frame: two years
description: Calculated with 95% confidence interval
measure: Rate of toxicities and grades
time frame: two years
description: Categorical data summarized by pecentages
measure: Peak and trough levels of capecitabine and relation to dosing
time frame: Two years
description: Numerical data summarized by means and standard deviation
measure: Progression free survival
time frame: two years
description: Cox proportional hazard model
measure: Overall survival
time frame: Two years
description: Kaplan and Meier test
arm group label: Classic (A)
arm group type: Active Comparator
description: patients recieving classic XELOX (oxaliplatin 130mg/m2 and capecitabine 1000mg/m2 bid)
arm group label: metronomic (B)
arm group type: Experimental
description: patients recieving low dose capecitabine (2000mg daily divided in two doses for 8 weeks) and oxaliplatin (30mg/m2 weekly for eight weeks) followed by 2 weeks rest.
intervention type: Drug
intervention name: metronomic XELOX
arm group label: metronomic (B)
other name: Capecitabine
other name: Oxaliplatin
intervention type: Drug
intervention name: Classic XELOX
arm group label: Classic (A)
other name: Capecitabine
other name: Oxaliplatin
intervention type: Other
intervention name: Blood samples for pharmacological studies
arm group label: Classic (A)
arm group label: metronomic (B)
other name: No other names
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Capecitabine
mesh term: Oxaliplatin
sharing ipd: No
submitted: September 17, 2020
returned: October 9, 2020
submitted: March 9, 2021
returned: April 2, 2021