<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/NCT01672333</url>
  </required_header>
  <id_info>
    <org_study_id>TOX protocol</org_study_id>
    <nct_id>NCT01672333</nct_id>
  </id_info>
  <brief_title>Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma</brief_title>
  <acronym>TOX</acronym>
  <official_title>Phase 2 Study of Response Rate and Side Effects of Preoperative Chemotherapy With Docetaxel, Oxaliplatin and Capcitabine (TOX) in Patients With Locally Advanced Operable Gastric Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milad Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milad Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early stage diagnosis of gastric cancer has ensued different approaches in its resection&#xD;
      strategies. In order to increase the proportion of cases that undergo radical resection and&#xD;
      reduce the recurrence rate, different pre-operative treatments are introduced. Here, the&#xD;
      investigators investigate an active preoperative chemotherapeutic regimen to in patients with&#xD;
      locally advanced gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2008</start_date>
  <primary_completion_date type="Actual">March 2011</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>Pathologic Response rate</measure>
    <time_frame>Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol.</time_frame>
    <description>A single expert pathologist evaluates the pathologic outcome of the chemotherapy regimen after the completion of courses. Participants are divided into 3 groups including complete pathologic response, partial pathologic response and pathologic stable disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical Response rate</measure>
    <time_frame>Participants are assessed after 2 courses of Chemotherapy 3 weeks apart, an expected period of 6 weeks from starting the study treatment protocol.</time_frame>
    <description>A single expert clinician evaluates the clinical outcome of the chemotherapy regimen after 2 primary courses 3 weeks apart. Evaluation is done with regards to the &quot;TNM&quot; scoring of gastric cancer (T for the size and expansion of the tumor, N for lymph node involvement, M for distant metastasis). Participants are divided into 4 groups including clinically progressive disease, complete clinical response, partial clinical response and clinically stable disease.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Pathological Response</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TOX</intervention_name>
    <description>oxaliplatin 100mg/m2 IV over 2 hours at 1st day docetaxel 50 mg/m2 IV over 1 hour at 1st day capecitabine 625 mg/m2 PO for 14 days</description>
    <arm_group_label>Pathological Response</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tissue diagnosis of gastric or gastroesophageaql junction Adenocarcinoma&#xD;
&#xD;
          -  T3, T4 any N with non metastatic condition&#xD;
&#xD;
          -  Age 18 - 70 years&#xD;
&#xD;
          -  Performance status 0,1 according to ECOG criteria&#xD;
&#xD;
          -  Adequate bone marrow , liver and renal function&#xD;
&#xD;
          -  Hemoglobin ≥ 11 g/dl&#xD;
&#xD;
          -  Platelets ≥ 100000 / mm3&#xD;
&#xD;
          -  Absolute Neutrophil Count ≥ 1500/mm3&#xD;
&#xD;
          -  Normal Bilirubin&#xD;
&#xD;
          -  Normal Transaminases&#xD;
&#xD;
          -  Normal creatinin&#xD;
&#xD;
          -  Absence of active co-morbid illness (uncontrolled infection, uncontrolled DM,&#xD;
             cardiopulmonary disease)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any metastatic disease, T1, T2, N0&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bahram Salmanian, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Milad Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fayyazbakhsh hospital</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>March 18, 2014</last_update_submitted>
  <last_update_submitted_qc>March 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milad Hospital</investigator_affiliation>
    <investigator_full_name>Dr Seyed-Hossein Yahyazadeh-Jabari</investigator_full_name>
    <investigator_title>Director of Clinical Research Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_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/NCT01672333
org study id: TOX protocol
nct id: NCT01672333
lead sponsor: 
has dmc: Yes
Early stage diagnosis of gastric cancer has ensued different approaches in its resection
      strategies. In order to increase the proportion of cases that undergo radical resection and
      reduce the recurrence rate, different pre-operative treatments are introduced. Here, the
      investigators investigate an active preoperative chemotherapeutic regimen to in patients with
      locally advanced gastric cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathologic Response rate
time frame: Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol.
description: A single expert pathologist evaluates the pathologic outcome of the chemotherapy regimen after the completion of courses. Participants are divided into 3 groups including complete pathologic response, partial pathologic response and pathologic stable disease.
measure: clinical Response rate
time frame: Participants are assessed after 2 courses of Chemotherapy 3 weeks apart, an expected period of 6 weeks from starting the study treatment protocol.
description: A single expert clinician evaluates the clinical outcome of the chemotherapy regimen after 2 primary courses 3 weeks apart. Evaluation is done with regards to the "TNM" scoring of gastric cancer (T for the size and expansion of the tumor, N for lymph node involvement, M for distant metastasis). Participants are divided into 4 groups including clinically progressive disease, complete clinical response, partial clinical response and clinically stable disease.
arm group label: Pathological Response
arm group type: Experimental
intervention type: Drug
intervention name: TOX
description: oxaliplatin 100mg/m2 IV over 2 hours at 1st day docetaxel 50 mg/m2 IV over 1 hour at 1st day capecitabine 625 mg/m2 PO for 14 days
arm group label: Pathological Response
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Bahram Salmanian, M.D.
role: Principal Investigator
affiliation: Milad Hospital
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Milad Hospital
investigator full name: Dr Seyed-Hossein Yahyazadeh-Jabari
investigator title: Director of Clinical Research Center
mesh term: Adenocarcinoma