<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/NCT03254511</url>
  </required_header>
  <id_info>
    <org_study_id>941703</org_study_id>
    <secondary_id>IRCT2016070628814N1</secondary_id>
    <nct_id>NCT03254511</nct_id>
  </id_info>
  <brief_title>Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer</brief_title>
  <official_title>The Effect of Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer on the Clinical and Pathologic Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mashhad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</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>
      This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion&#xD;
      criteria are consist of non-metastatic esophageal cancer who are going to receive&#xD;
      chemo-radiotherapy. Sample size is 100 people (50 people in each group). In the intervention&#xD;
      group, patients are going to inject an enoxaparin (40 mg) daily concurrent by&#xD;
      chemo-radiation. Therefore patients with esophageal cancer are going to assign randomly to&#xD;
      control group (only chemo-radiotherapy) and intervention group&#xD;
      (chemo-radiotherapy+enoxaparin) using 1:1 allocation. Four to 6 weeks after treatment, all&#xD;
      patients undergo upper GI endoscopy and then esophagectomy. Endoscopic and pathological&#xD;
      findings (after esophagectomy) are considered as clinical and pathological response,&#xD;
      respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion&#xD;
      criteria are consist of non-metastatic esophageal cancer who are going to receive&#xD;
      chemo-radiotherapy. One hundred patients are going to assign randomly by blocked randomized&#xD;
      allocation (1:1) to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32&#xD;
      fractions) with weekly concurrent chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area&#xD;
      under the carve=2]) with or without enoxaparin (40 mg daily). During radiotherapy and before&#xD;
      each course of chemotherapy, all patients are going to visit by physician and complete blood&#xD;
      count will be checked. All patients are going to undergo gastrointestinal endoscopy and then&#xD;
      esophagectomy, 4-6 months after completion of chemo-radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 22, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical response</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>according to endoscopic findings (no lesion, primary lesion or became smaller less than 50%of primary lesion, become smaller more than 50% of primary lesion)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pathologic response</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>according to pathologic findings of esophageus specimen (complete Vs incomplete)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>R staging (residual of tumor)</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heparin induced thrombocytopenia</measure>
    <time_frame>through study completion, an average of 5 weeks</time_frame>
    <description>according to complete blood count</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Esophageal Neoplasms</condition>
  <arm_group>
    <arm_group_label>enoxaparin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the enoxaparin group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable (40 mg daily).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable</intervention_name>
    <description>Patients are going to receive subcutaneouse Enoxaparin (40 mg daily).</description>
    <arm_group_label>enoxaparin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>enoxaparin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapeutic Combinations</intervention_name>
    <description>Patients are going to receive weekly chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]).</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>enoxaparin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Definitive diagnoses of esophageal squamous cell carcinoma by pathological evaluation&#xD;
&#xD;
          -  Non-metastatic esophageal cancer&#xD;
&#xD;
          -  Patient who are candidate for chemo-radiation treatment&#xD;
&#xD;
          -  Normal complete blood count&#xD;
&#xD;
          -  Normal kidney function test&#xD;
&#xD;
          -  Normal liver function test&#xD;
&#xD;
          -  Normal fasting blood sugar&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of chest wall radiotherapy&#xD;
&#xD;
          -  Previous history of chemotherapy&#xD;
&#xD;
          -  Past medical history of Hypertension, diabetes mellitus, renal failure and liver&#xD;
             failure&#xD;
&#xD;
          -  Pathological report of adenocarcinoma or small cell carcinoma, neoplasm of other&#xD;
             organs&#xD;
&#xD;
          -  Discontent for the study&#xD;
&#xD;
          -  Inability to do daily radiotherapy&#xD;
&#xD;
          -  Unwillingness to esophagectomy&#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>Ali Taghizadeh Kermani, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sareh Hosseini, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seyed Alireza Javadinia, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arezoo Gholami, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arezoo Gholami, M.D.</last_name>
    <phone>00989155252690</phone>
    <email>gholamia931@mums.ac.ir</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mashhad University of Medical Sciences</name>
      <address>
        <city>Mashhad</city>
        <state>Khorasan Razavi</state>
        <zip>917751365</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohsen Tafaghodi, M.D.</last_name>
      <phone>00985138823255</phone>
      <email>vcresearch@mums.ac.ir</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Seyed Alireza Javadinia</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>neoadjuvant chemoradiation</keyword>
  <keyword>pathologic response</keyword>
  <keyword>low molecular weight heparin</keyword>
  <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>Enoxaparin</mesh_term>
    <mesh_term>Enoxaparin sodium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 28, 2018</submitted>
    <returned>October 30, 2018</returned>
  </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/NCT03254511
org study id: 941703
secondary id: IRCT2016070628814N1
nct id: NCT03254511
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion
      criteria are consist of non-metastatic esophageal cancer who are going to receive
      chemo-radiotherapy. Sample size is 100 people (50 people in each group). In the intervention
      group, patients are going to inject an enoxaparin (40 mg) daily concurrent by
      chemo-radiation. Therefore patients with esophageal cancer are going to assign randomly to
      control group (only chemo-radiotherapy) and intervention group
      (chemo-radiotherapy+enoxaparin) using 1:1 allocation. Four to 6 weeks after treatment, all
      patients undergo upper GI endoscopy and then esophagectomy. Endoscopic and pathological
      findings (after esophagectomy) are considered as clinical and pathological response,
      respectively.
This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion
      criteria are consist of non-metastatic esophageal cancer who are going to receive
      chemo-radiotherapy. One hundred patients are going to assign randomly by blocked randomized
      allocation (1:1) to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32
      fractions) with weekly concurrent chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area
      under the carve=2]) with or without enoxaparin (40 mg daily). During radiotherapy and before
      each course of chemotherapy, all patients are going to visit by physician and complete blood
      count will be checked. All patients are going to undergo gastrointestinal endoscopy and then
      esophagectomy, 4-6 months after completion of chemo-radiotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: clinical response
time frame: up to 6 weeks
description: according to endoscopic findings (no lesion, primary lesion or became smaller less than 50%of primary lesion, become smaller more than 50% of primary lesion)
measure: pathologic response
time frame: up to 6 weeks
description: according to pathologic findings of esophageus specimen (complete Vs incomplete)
measure: R staging (residual of tumor)
time frame: up to 6 weeks
description: according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)
measure: heparin induced thrombocytopenia
time frame: through study completion, an average of 5 weeks
description: according to complete blood count
arm group label: enoxaparin
arm group type: Experimental
description: In the enoxaparin group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable (40 mg daily).
arm group label: control
arm group type: Active Comparator
description: In the control group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) alone.
intervention type: Drug
intervention name: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable
description: Patients are going to receive subcutaneouse Enoxaparin (40 mg daily).
arm group label: enoxaparin
intervention type: Radiation
intervention name: Radiotherapy
description: Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.
arm group label: control
arm group label: enoxaparin
intervention type: Drug
intervention name: Chemotherapeutic Combinations
description: Patients are going to receive weekly chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]).
arm group label: control
arm group label: enoxaparin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ali Taghizadeh Kermani, M.D.
role: Study Chair
affiliation: Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
last name: Sareh Hosseini, M.D.
role: Study Director
affiliation: Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
last name: Seyed Alireza Javadinia, M.D.
role: Principal Investigator
affiliation: Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
last name: Arezoo Gholami, M.D.
role: Principal Investigator
affiliation: Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
last name: Arezoo Gholami, M.D.
phone: 00989155252690
email: gholamia931@mums.ac.ir
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: Seyed Alireza Javadinia
investigator title: Principal Investigator
mesh term: Esophageal Neoplasms
mesh term: Enoxaparin
mesh term: Enoxaparin sodium
sharing ipd: Undecided
submitted: March 28, 2018
returned: October 30, 2018