<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/NCT01679054</url>
  </required_header>
  <id_info>
    <org_study_id>Roche-TR116582</org_study_id>
    <secondary_id>TR116582VLKZ001</secondary_id>
    <nct_id>NCT01679054</nct_id>
  </id_info>
  <brief_title>Cost-minimization Analysis of Gastric Cancer Treatments in Hong Kong</brief_title>
  <official_title>Cost-minimization Analysis of Xeloda® vs 5-fluorouracil-based Treatment for Gastric Cancer Patients in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vivian Wing Yan Lee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Princess Margaret Hospital Department of Pharmacy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Princess Margaret Hospital Department of Clinical Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pamela Youde Nethersole Eastern Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective cost-minimization analysis study to compare the costs of treatment&#xD;
      with EOF vs EOX regimens in patients with gastric cancer (GC) in Hong Kong. Patient baseline&#xD;
      characteristics and cost data will be extracted from records and compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      The oral chemotherapy agent Xeloda® was recently extended by the Hong Kong Hospital Authority&#xD;
      as subsidized therapy for the treatment of colorectal cancer1. Xeloda®-based chemotherapy&#xD;
      regimen has shown to be more cost-effective than 5-fluorouracil (5-FU) considering they had&#xD;
      equivalent clinical efficacy in colorectal cancer treatment2,3. The total cost for 5-FU-based&#xD;
      regimen was higher for the healthcare provider and society as a whole. Gastric cancer ranks&#xD;
      fourth in cancer-related cause of death in the Hong Kong population4. 5-FU has known&#xD;
      antitumor activity and has been used successfully in advanced gastric cancer (aGC) with&#xD;
      cisplatin (FP), as well as with oxaliplatin ± epirubicin (FOLFOX4, EOF). When substituted&#xD;
      with Xeloda®, the XP and EOX regimens have demonstrated to be noninferior in terms of&#xD;
      progression-free survival when compared with FP and EOF, respectively5,6. In an economics&#xD;
      evaluation done by the manufacturer for NICE submission on the use of Xeloda® for treatment&#xD;
      of aGC, the use of XP regimen allowed a cost reduction while eliminating possible&#xD;
      complication related to intravenous therapy7. Moreover, FOLFOX4, one of the common 5-FU-based&#xD;
      regimens used locally, has demonstrated to produce a median overall survival of 10 months in&#xD;
      advanced/metastatic gastric cancer patients8. An effect similar to that of EOX. Currently,&#xD;
      there is no local data suggesting similar economic impact with Xeloda®-based regimen for&#xD;
      gastric cancer when compared with 5-FU-based regimens. It is worthwhile to see if&#xD;
      Xeloda®-based therapy for gastric cancer is a cost-effective alternative.&#xD;
&#xD;
      Study Objective&#xD;
&#xD;
      To compare retrospective costs of treatment with Xeloda®-based and 5-FU-based regiments in&#xD;
      patients with advanced gastric cancer in Hong Kong.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      This is a retrospective cost-minimization study to be conducted in a public hospital in Hong&#xD;
      Kong. Sixty (60) gastric cancer patients will be identified from existing case records (30&#xD;
      who completed a Xeloda®-based regimen and 30 who completed a 5-FU-based regimen) in the study&#xD;
      sites. Baseline characteristics from both groups prior to chemotherapy, including&#xD;
      demographics, ECOG performance score, liver/renal function, metastases, and survival will be&#xD;
      obtained. Cost data will also be extracted from patient records.&#xD;
&#xD;
      Information to be collected include cost of hospital admission and length of stay, outpatient&#xD;
      visits, diagnostic tests and treatments, chemotherapy regimens, all other drug therapy,&#xD;
      adverse side effect management, travel, and patient time. Baseline characteristics and costs&#xD;
      will be compared. Descriptive statistics will be utilized and sensitivity analysis will be&#xD;
      performed to investigate the robustness of the cost model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Expected and unexpected provider costs</measure>
    <time_frame>At the completion of respective chemotherapy regimen</time_frame>
    <description>Expected and unexpected provider costs (chemotherapy, hospital stay, lab tests, clinic visits, AE management, other drug costs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Expected and unexpected societal costs</measure>
    <time_frame>At the completion of respective chemotherapy regimen</time_frame>
    <description>Expected and unexpected societal costs (patient time, travel)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">58</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>EOX</arm_group_label>
    <description>Epirubicin + Oxaliplatin + Capecitabine (EOX) Epirubicin 50 mg/m2 iv bolus d1 q3w x 8 cycles Oxaliplatin (Eloxatin) 130 mg/m2 iv over 2 hours d1 q3w x 8 cycles Capecitabine (Xeloda) 625 mg/m2 po bid x 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FOLFOX4</arm_group_label>
    <description>FOLFOX4 Leucovorin 200 mg/m2 iv over 2 hrs before 5-FU, d1 and 2 5-FU 400 mg/m2 iv bolus and then 600 mg/m2 iv over 22 hrs, d 1 and d2 Oxaliplatin (Eloxatin) 85 mg/m2 iv d1 Q2w x 12 cycles</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        CDARS data will be accessed at respective sites to identify patients with aGC who have&#xD;
        completed either EOX or EOF regimens.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were diagnosed with gastric cancer and completed either EOX or EOF&#xD;
             chemotherapy treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years of age&#xD;
&#xD;
          -  Patient who did not meet inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>August 31, 2012</last_update_submitted>
  <last_update_submitted_qc>August 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Vivian Wing Yan Lee</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Neoplasm</keyword>
  <keyword>Gastric Cancer</keyword>
  <keyword>Cost</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 22, 2020</submitted>
    <returned>January 29, 2020</returned>
    <submitted>July 25, 2022</submitted>
    <returned>May 26, 2023</returned>
    <submitted>August 28, 2023</submitted>
  </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/NCT01679054
org study id: Roche-TR116582
secondary id: TR116582VLKZ001
nct id: NCT01679054
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a retrospective cost-minimization analysis study to compare the costs of treatment
      with EOF vs EOX regimens in patients with gastric cancer (GC) in Hong Kong. Patient baseline
      characteristics and cost data will be extracted from records and compared.
Background

      The oral chemotherapy agent Xeloda® was recently extended by the Hong Kong Hospital Authority
      as subsidized therapy for the treatment of colorectal cancer1. Xeloda®-based chemotherapy
      regimen has shown to be more cost-effective than 5-fluorouracil (5-FU) considering they had
      equivalent clinical efficacy in colorectal cancer treatment2,3. The total cost for 5-FU-based
      regimen was higher for the healthcare provider and society as a whole. Gastric cancer ranks
      fourth in cancer-related cause of death in the Hong Kong population4. 5-FU has known
      antitumor activity and has been used successfully in advanced gastric cancer (aGC) with
      cisplatin (FP), as well as with oxaliplatin ± epirubicin (FOLFOX4, EOF). When substituted
      with Xeloda®, the XP and EOX regimens have demonstrated to be noninferior in terms of
      progression-free survival when compared with FP and EOF, respectively5,6. In an economics
      evaluation done by the manufacturer for NICE submission on the use of Xeloda® for treatment
      of aGC, the use of XP regimen allowed a cost reduction while eliminating possible
      complication related to intravenous therapy7. Moreover, FOLFOX4, one of the common 5-FU-based
      regimens used locally, has demonstrated to produce a median overall survival of 10 months in
      advanced/metastatic gastric cancer patients8. An effect similar to that of EOX. Currently,
      there is no local data suggesting similar economic impact with Xeloda®-based regimen for
      gastric cancer when compared with 5-FU-based regimens. It is worthwhile to see if
      Xeloda®-based therapy for gastric cancer is a cost-effective alternative.

      Study Objective

      To compare retrospective costs of treatment with Xeloda®-based and 5-FU-based regiments in
      patients with advanced gastric cancer in Hong Kong.

      Methods

      This is a retrospective cost-minimization study to be conducted in a public hospital in Hong
      Kong. Sixty (60) gastric cancer patients will be identified from existing case records (30
      who completed a Xeloda®-based regimen and 30 who completed a 5-FU-based regimen) in the study
      sites. Baseline characteristics from both groups prior to chemotherapy, including
      demographics, ECOG performance score, liver/renal function, metastases, and survival will be
      obtained. Cost data will also be extracted from patient records.

      Information to be collected include cost of hospital admission and length of stay, outpatient
      visits, diagnostic tests and treatments, chemotherapy regimens, all other drug therapy,
      adverse side effect management, travel, and patient time. Baseline characteristics and costs
      will be compared. Descriptive statistics will be utilized and sensitivity analysis will be
      performed to investigate the robustness of the cost model.
observational model: Cohort
time perspective: Retrospective
measure: Expected and unexpected provider costs
time frame: At the completion of respective chemotherapy regimen
description: Expected and unexpected provider costs (chemotherapy, hospital stay, lab tests, clinic visits, AE management, other drug costs)
measure: Expected and unexpected societal costs
time frame: At the completion of respective chemotherapy regimen
description: Expected and unexpected societal costs (patient time, travel)
arm group label: EOX
description: Epirubicin + Oxaliplatin + Capecitabine (EOX) Epirubicin 50 mg/m2 iv bolus d1 q3w x 8 cycles Oxaliplatin (Eloxatin) 130 mg/m2 iv over 2 hours d1 q3w x 8 cycles Capecitabine (Xeloda) 625 mg/m2 po bid x 6 months
arm group label: FOLFOX4
description: FOLFOX4 Leucovorin 200 mg/m2 iv over 2 hrs before 5-FU, d1 and 2 5-FU 400 mg/m2 iv bolus and then 600 mg/m2 iv over 22 hrs, d 1 and d2 Oxaliplatin (Eloxatin) 85 mg/m2 iv d1 Q2w x 12 cycles
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Sponsor-Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Vivian Wing Yan Lee
investigator title: Associate Professor
mesh term: Stomach Neoplasms
submitted: January 22, 2020
returned: January 29, 2020
submitted: July 25, 2022
returned: May 26, 2023
submitted: August 28, 2023