<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/NCT03838406</url>
  </required_header>
  <id_info>
    <org_study_id>1771-001-287</org_study_id>
    <nct_id>NCT03838406</nct_id>
  </id_info>
  <brief_title>BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer</brief_title>
  <official_title>A Pilot Trial of Platinum Based Chemotherapy According to BRCA Expressions as First-line Chemotherapy in Patients With Metastatic Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chung-Ang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chung-Ang University</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>
      The investigators evaluated the incidence of BRCA loss in patients with advanced gastric&#xD;
      cancer and observed the treatment outcome and prognosis according to BRCA loss. And the&#xD;
      investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stomach cancer is still the leading cause of cancer deaths globally and is reported to be the&#xD;
      second leading cause of cancer deaths in Korea (18.7%). Although the number of radical&#xD;
      resection has increased due to the development of early diagnosis, many patients experience&#xD;
      recurrence after radical resection. It is also diagnosed as a non - resectable disease&#xD;
      locally advanced at the time of initial diagnosis, or with a metastasis. In patients with&#xD;
      recurrent / metastatic gastric cancer, conventional palliative chemotherapy is the best&#xD;
      treatment, and in advanced gastric cancer, combination therapy with fluoropyrimidine&#xD;
      (fluorouracil, capecitabine, S1) and platinum (oxaliplatin, cisplatin). The progression-free&#xD;
      survival was 3-5 months, and overall survival of 6-10 months in metastatic gastric cancer&#xD;
      patients.&#xD;
&#xD;
      The investigators evaluated the incidence of BRCA loss in patients with advanced gastric&#xD;
      cancer and observed the treatment outcome and prognosis according to BRCA loss. And the&#xD;
      investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</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>Objective response rate</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>the time from diagnosis to death by any cause and progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>the time from diagnosis to death by any cause</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>BRCA Gene Rearrangement</condition>
  <arm_group>
    <arm_group_label>BRCA1 positive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FOLFOX or CAPOX Chemotherapy&#xD;
FOLFOX :&#xD;
Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.&#xD;
CAPOX:&#xD;
Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BRCA1 negative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FOLFOX or CAPOX Chemotherapy&#xD;
FOLFOX :&#xD;
Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + 5-FU 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.&#xD;
CAPOX:&#xD;
Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>BRCA 1</intervention_name>
    <description>The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis.</description>
    <arm_group_label>BRCA1 negative</arm_group_label>
    <arm_group_label>BRCA1 positive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>FOLFOX :&#xD;
Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.&#xD;
CAPOX:&#xD;
Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.</description>
    <arm_group_label>BRCA1 negative</arm_group_label>
    <arm_group_label>BRCA1 positive</arm_group_label>
    <other_name>FOLFOX or CAPOX</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastatic gastric cancer( Adenocarcinoma)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance 0-2&#xD;
&#xD;
          -  one more measure lesion&#xD;
&#xD;
          -  White blood cell count (WBC) &gt; 3000/ul , Platelet &gt; 75,000/ul&#xD;
&#xD;
          -  Normal kidney function (serum creatinine &lt; 1.5 ULN)&#xD;
&#xD;
          -  Normal Liver function (Aspartate aminotransferase (AST)/ Alanine aminotransferase&#xD;
             (ALT) &lt; 3 times of upper normal limit, if liver metastasis, AST/ALT &lt; 5 times of upper&#xD;
             normal limit)&#xD;
&#xD;
          -  life expectancy is more than 3 months&#xD;
&#xD;
          -  Conventional surgery that does not cause the transformation of the target lesion is&#xD;
             allowed&#xD;
&#xD;
          -  The patient who voluntarily decided to participate in this study and agreed in writing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Her-2 positive advanced gastric cancer&#xD;
&#xD;
          -  Central nervous system metastases requiring treatment with symptoms&#xD;
&#xD;
          -  Major uncontrolled cardiovascular disease (including myocardial infarction and&#xD;
             congestive heart failure within 6 months)&#xD;
&#xD;
          -  Uncontrolled infection or other serious diseases&#xD;
&#xD;
          -  Patients with serious medical conditions or serious illnesses&#xD;
&#xD;
          -  Patient who is pregnant or lactating&#xD;
&#xD;
          -  Adjuvant chemotherapy before 6 months (patients who have not received platinum-based&#xD;
             chemotherapy even if they are 6 months old can register)&#xD;
&#xD;
          -  In the past, if the primary lesion or target lesion was treated with radiation (if the&#xD;
             recurred lesion is outside the range of radiation therapy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>In Gyu Hwang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chung-Ang University Hosptial, Chung-Ang University College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chung-Ang University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>06973</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chung-Ang University</investigator_affiliation>
    <investigator_full_name>In Gyu Hwang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Stomach cancer</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>FOLFOX</keyword>
  <keyword>Capecitabine plus Oxalipatin (CAPOX)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03838406
org study id: 1771-001-287
nct id: NCT03838406
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators evaluated the incidence of BRCA loss in patients with advanced gastric
      cancer and observed the treatment outcome and prognosis according to BRCA loss. And the
      investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.
Stomach cancer is still the leading cause of cancer deaths globally and is reported to be the
      second leading cause of cancer deaths in Korea (18.7%). Although the number of radical
      resection has increased due to the development of early diagnosis, many patients experience
      recurrence after radical resection. It is also diagnosed as a non - resectable disease
      locally advanced at the time of initial diagnosis, or with a metastasis. In patients with
      recurrent / metastatic gastric cancer, conventional palliative chemotherapy is the best
      treatment, and in advanced gastric cancer, combination therapy with fluoropyrimidine
      (fluorouracil, capecitabine, S1) and platinum (oxaliplatin, cisplatin). The progression-free
      survival was 3-5 months, and overall survival of 6-10 months in metastatic gastric cancer
      patients.

      The investigators evaluated the incidence of BRCA loss in patients with advanced gastric
      cancer and observed the treatment outcome and prognosis according to BRCA loss. And the
      investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate
time frame: through study completion, an average of 1 year
description: the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.
measure: Progression free survival
time frame: through study completion, an average of 1 year
description: the time from diagnosis to death by any cause and progression.
measure: Overall survival
time frame: through study completion, an average of 1 year
description: the time from diagnosis to death by any cause
arm group label: BRCA1 positive
arm group type: Experimental
description: FOLFOX or CAPOX Chemotherapy
FOLFOX :
Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.
CAPOX:
Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.
arm group label: BRCA1 negative
arm group type: Active Comparator
description: FOLFOX or CAPOX Chemotherapy
FOLFOX :
Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + 5-FU 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.
CAPOX:
Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.
intervention type: Genetic
intervention name: BRCA 1
description: The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis.
arm group label: BRCA1 negative
arm group label: BRCA1 positive
intervention type: Drug
intervention name: Chemotherapy
description: FOLFOX :
Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.
CAPOX:
Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.
arm group label: BRCA1 negative
arm group label: BRCA1 positive
other name: FOLFOX or CAPOX
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: In Gyu Hwang
role: Principal Investigator
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chung-Ang University
investigator full name: In Gyu Hwang
investigator title: Associate Professor
mesh term: Stomach Neoplasms
sharing ipd: No