xml: <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/NCT05997524</url>
    </required_header>
    <id_info>
      <org_study_id>SHL/2021/01</org_study_id>
      <nct_id>NCT05997524</nct_id>
    </id_info>
    <brief_title>Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer.</brief_title>
    <official_title>Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer: A Multicenter, Phase II Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Trastuzumab plus chemotherapy prolonged the median overall survival in patients with human&#xD;
        epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Among&#xD;
        chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin,&#xD;
        and becoming an increasingly popular option for the treatment of AGC. The aim of the study&#xD;
        was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and&#xD;
        oxaliplatin (CAPOX) in HER2-positive AGC.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">February 28, 2022</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>Loco-regional and Distant Tumor Control After Completion of Treatment</measure>
      <time_frame>12 months</time_frame>
      <description>Response Evaluation Criteria in Solid Tumors was used to measure outcome:&#xD;
  Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions.&#xD;
  Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions.&#xD;
  Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>28 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>28 months</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Advanced Gastric Carcinoma</condition>
    <arm_group>
      <arm_group_label>Tras-Capox</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Trastuzumab</intervention_name>
      <description>Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w).</description>
      <arm_group_label>Tras-Capox</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxaliplatin</intervention_name>
      <description>Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles.</description>
      <arm_group_label>Tras-Capox</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capecitabine</intervention_name>
      <description>Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval.</description>
      <arm_group_label>Tras-Capox</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  HER2-positive AGC defined as either HER2 immunohistochemistry (IHC) 3+ or IHC 2+ and&#xD;
               fluorescence in situ hybridization (FISH)+ with no history of previous treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#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>Sarwar Alam, MBBS, Mphil</last_name>
      <role>Study Chair</role>
      <affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Bangabandhu Sheikh Mujib Medical University</name>
        <address>
          <city>Dhaka</city>
          <zip>1000</zip>
          <country>Bangladesh</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Bangladesh</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
      <investigator_full_name>Dr. Ishtiaq-Ur-Rahim</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach 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>
      <mesh_term>Trastuzumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997524
  org study id: SHL/2021/01
  nct id: NCT05997524
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Trastuzumab plus chemotherapy prolonged the median overall survival in patients with human
        epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Among
        chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin,
        and becoming an increasingly popular option for the treatment of AGC. The aim of the study
        was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and
        oxaliplatin (CAPOX) in HER2-positive AGC.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Loco-regional and Distant Tumor Control After Completion of Treatment
  time frame: 12 months
  description: Response Evaluation Criteria in Solid Tumors was used to measure outcome:
  Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions.
  Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions.
  Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
  measure: Progression-free survival (PFS)
  time frame: 28 months
  measure: Overall survival (OS)
  time frame: 28 months
  arm group label: Tras-Capox
  arm group type: Experimental
  intervention type: Drug
  intervention name: Trastuzumab
  description: Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w).
  arm group label: Tras-Capox
  intervention type: Drug
  intervention name: Oxaliplatin
  description: Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles.
  arm group label: Tras-Capox
  intervention type: Drug
  intervention name: Capecitabine
  description: Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval.
  arm group label: Tras-Capox
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sarwar Alam, MBBS, Mphil
  role: Study Chair
  affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  facility: 
  country: Bangladesh
  responsible party type: Principal Investigator
  investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  investigator full name: Dr. Ishtiaq-Ur-Rahim
  investigator title: Principal Investigator
  mesh term: Stomach Neoplasms
  mesh term: Capecitabine
  mesh term: Oxaliplatin
  mesh term: Trastuzumab
  sharing ipd: No