<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/NCT01710592</url>
  </required_header>
  <id_info>
    <org_study_id>ICORG 06-05</org_study_id>
    <nct_id>NCT01710592</nct_id>
    <nct_alias>NCT00806949</nct_alias>
  </id_info>
  <brief_title>A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer</brief_title>
  <acronym>ELECT</acronym>
  <official_title>A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Trials Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Trials Ireland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Whilst oxaliplatin and docetaxel have established activity in the treatment of advanced&#xD;
      gastro-oesophageal cancer, their role, however, in the management of this disease remains&#xD;
      unclear. Furthermore it is unclear whether this disease is optimally treated with a&#xD;
      combination of two or three cytotoxic drugs. This trial aims to determine whether the&#xD;
      combination of oxaliplatin and weekly docetaxel warrants further investigation in a formal&#xD;
      phase III trial. The combination of epirubicin, oxaliplatin and capecitabine will be the&#xD;
      comparator arm for this evaluation.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is&#xD;
      comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation&#xD;
      in advanced gastro-oesophageal cancer.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      To examine the effect of treatment on time to progression, progression free survival, overall&#xD;
      survival, quality of life, and the associated toxicity from treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomised two-arm parallel group phase II study. 140 patients will be recruited&#xD;
      over a period of 12 months, and will be randomised to receive either eight 3-weekly cycles of&#xD;
      Epirubicin, Oxaliplatin and Capecitabine (EOX) or six 4-weekly cycles of Docetaxel and&#xD;
      Oxaliplatin (EITax).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2007</start_date>
  <primary_completion_date type="Actual">December 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>Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer</measure>
    <time_frame>Two Years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>In addition we will examine the effect of treatment on time to progression.</measure>
    <time_frame>Two Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To examine the associated toxicity from treatment</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To examine the effect of treatment on survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To examine the effect of treatment on Quality of life.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Gastro Oesophageal Cancer</condition>
  <arm_group>
    <arm_group_label>Epirubicin, Oxaliplatin, Capecitabine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epirubicin 50mg/m2 (day 1) bolus injection&#xD;
Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours&#xD;
Capecitabine 625mg/m2 (days 1-21) b.d. orally&#xD;
8 x 3-weekly cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Docetaxel, Oxaliplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Docetaxel 20mg/m2 (days 1, 8 &amp; 15)in 250mls of 5% dextrose. i.v. over 30mins (Dexamethasone 8mg i.v, Chlorpheniramine 10mg i.v,Ranitidine 50mg i.v. to be given 30 minutes prior to Docetaxel)&#xD;
Oxaliplatin 85mg/m2 (days 1 &amp; 15)in 250mls of 5% dextrose. i.v. over 2 hours&#xD;
6 x 4-weekly cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epirubicin</intervention_name>
    <arm_group_label>Epirubicin, Oxaliplatin, Capecitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <arm_group_label>Docetaxel, Oxaliplatin</arm_group_label>
    <arm_group_label>Epirubicin, Oxaliplatin, Capecitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <arm_group_label>Epirubicin, Oxaliplatin, Capecitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <arm_group_label>Docetaxel, Oxaliplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach,&#xD;
             gastro-oesophageal junction or lower third of the oesophagus with measurable disease&#xD;
             on CT scanning (see RECIST Criteria, Appendix C of the protocol for definition of&#xD;
             measureable disease).&#xD;
&#xD;
          -  No previous treatment for advanced disease (previous adjuvant/neo-adjuvant treatment&#xD;
             acceptable if &gt;12 months previously).&#xD;
&#xD;
          -  Absence of serious concomitant illness (i.e. MI within previous 6 months),&#xD;
             uncontrolled angina, uncontrolled hypertension, severe COPD (&gt;3 admissions for&#xD;
             infective exacerbation in past 12 months) etc.&#xD;
&#xD;
          -  ECOG performance status ≤ 2.&#xD;
&#xD;
          -  Age ≥ to 18.&#xD;
&#xD;
          -  Life expectancy ≥ 3 months&#xD;
&#xD;
          -  Adequate renal, hepatic and bone marrow function&#xD;
&#xD;
          -  Creatinine clearance ≥ 50 ml/min as calculated using the Cockcroft and Gault formula&#xD;
             (see Appendix L).&#xD;
&#xD;
          -  Liver function tests:&#xD;
&#xD;
        Bilirubin ≤ 1.0 x ULN, AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN,Haemoglobin &gt; 10.0 g/dl, Absolute&#xD;
        neutrophil count &gt;1.5 x 109 /L, Platelet count &gt; 100 x109/L.&#xD;
&#xD;
        •Before randomisation, written informed consent must be given according to ICH/GCP, and&#xD;
        national/local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptoms or signs of peripheral neuropathy.&#xD;
&#xD;
          -  Patients known to have second or third degree heart block.&#xD;
&#xD;
          -  Previous or concurrent malignancy, with the exception of basal cell carcinoma of the&#xD;
             skin or in-situ neoplasia of the uterine cervix.&#xD;
&#xD;
          -  Known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines.&#xD;
&#xD;
          -  Pregnant or nursing.&#xD;
&#xD;
          -  Female of child-bearing potential, or male partner of female of child bearing&#xD;
             potential not taking adequate contraceptive precautions.&#xD;
&#xD;
          -  Any psychological, familial, sociological or geographical condition potentially&#xD;
             hampering compliance with the study protocol and follow-up schedule; those conditions&#xD;
             should be discussed with the patient before registration in 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>Martin Eatock, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Trials Ireland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mercy University Hospital</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Misericordiae University hospital &amp; Mater Private Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James's Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Adelaide and Meath Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waterford Regional Hospital</name>
      <address>
        <city>Waterford</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>January 8, 2013</last_update_submitted>
  <last_update_submitted_qc>January 8, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2013</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>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Epirubicin</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/NCT01710592
org study id: ICORG 06-05
nct id: NCT01710592
nct alias: NCT00806949
lead sponsor: 
has dmc: No
Whilst oxaliplatin and docetaxel have established activity in the treatment of advanced
      gastro-oesophageal cancer, their role, however, in the management of this disease remains
      unclear. Furthermore it is unclear whether this disease is optimally treated with a
      combination of two or three cytotoxic drugs. This trial aims to determine whether the
      combination of oxaliplatin and weekly docetaxel warrants further investigation in a formal
      phase III trial. The combination of epirubicin, oxaliplatin and capecitabine will be the
      comparator arm for this evaluation.

      Primary Objective:

      Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is
      comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation
      in advanced gastro-oesophageal cancer.

      Secondary Objective:

      To examine the effect of treatment on time to progression, progression free survival, overall
      survival, quality of life, and the associated toxicity from treatment.
This is a randomised two-arm parallel group phase II study. 140 patients will be recruited
      over a period of 12 months, and will be randomised to receive either eight 3-weekly cycles of
      Epirubicin, Oxaliplatin and Capecitabine (EOX) or six 4-weekly cycles of Docetaxel and
      Oxaliplatin (EITax).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer
time frame: Two Years
measure: In addition we will examine the effect of treatment on time to progression.
time frame: Two Years
measure: To examine the associated toxicity from treatment
time frame: 2 years
measure: To examine the effect of treatment on survival
time frame: 2 years
measure: To examine the effect of treatment on Quality of life.
time frame: 2 years
arm group label: Epirubicin, Oxaliplatin, Capecitabine
arm group type: Active Comparator
description: Epirubicin 50mg/m2 (day 1) bolus injection
Oxaliplatin 130mg/m2 (day 1) in 250mls of 5% dextrose. i.v. over 2 hours
Capecitabine 625mg/m2 (days 1-21) b.d. orally
8 x 3-weekly cycle
arm group label: Docetaxel, Oxaliplatin
arm group type: Active Comparator
description: Docetaxel 20mg/m2 (days 1, 8 & 15)in 250mls of 5% dextrose. i.v. over 30mins (Dexamethasone 8mg i.v, Chlorpheniramine 10mg i.v,Ranitidine 50mg i.v. to be given 30 minutes prior to Docetaxel)
Oxaliplatin 85mg/m2 (days 1 & 15)in 250mls of 5% dextrose. i.v. over 2 hours
6 x 4-weekly cycle
intervention type: Drug
intervention name: Epirubicin
arm group label: Epirubicin, Oxaliplatin, Capecitabine
intervention type: Drug
intervention name: Oxaliplatin
arm group label: Docetaxel, Oxaliplatin
arm group label: Epirubicin, Oxaliplatin, Capecitabine
intervention type: Drug
intervention name: Capecitabine
arm group label: Epirubicin, Oxaliplatin, Capecitabine
intervention type: Drug
intervention name: Docetaxel
arm group label: Docetaxel, Oxaliplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Eatock, Dr
role: Principal Investigator
affiliation: Cancer Trials Ireland
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Ireland
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
mesh term: Docetaxel
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Epirubicin