<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/NCT01734863</url>
  </required_header>
  <id_info>
    <org_study_id>CCHE-BoneT002</org_study_id>
    <nct_id>NCT01734863</nct_id>
  </id_info>
  <brief_title>Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients</brief_title>
  <official_title>Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Cancer Hospital Egypt 57357</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Cancer Hospital Egypt 57357</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Local recurrence after surgical resection is a complex phenomenon. An important predictive&#xD;
      factor is the response to chemotherapy. Central site of disease may be a second independent&#xD;
      predictive factor (Lin et al. 2007). Patients with more than 10% viable tumour cells at&#xD;
      surgery following neo-adjuvant chemotherapy had a less favourable outcome with an Event-free&#xD;
      Survival [EFS] of 47% after 10 years. Patients with good histological response (&lt; 10% viable&#xD;
      tumour cells) after chemotherapy alone had a prognosis of about 70% after 10 years.&#xD;
&#xD;
      However, further studies are necessary to determine the merit of adjuvant radiation for&#xD;
      high-risk patients (poor responders). Taking into consideration that the toxicity and&#xD;
      morbidity of combined surgery and radiation is greater than either alone and must be closely&#xD;
      monitored.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</primary_completion_date>
  <phase>Phase 3</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>improved Local Relapse-free Survival (LRFS)</measure>
    <time_frame>five year event free survival</time_frame>
    <description>Determine whether the administration of post-operative radiotherapy for poor responder Ewing Sarcoma patients to neo-adjuvant chemotherapy and radical surgery, leads to improved Local Relapse-free Survival (LRFS).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Ewing's Sarcoma</condition>
  <arm_group>
    <arm_group_label>Radiotherapy Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this study arm will take External Beam radiotherapy as follows :&#xD;
Radiotherapy Technique: Conformal radiotherapy, Intensity modulated radiotherapy [IMRT] is allowed.&#xD;
Radiotherapy Dose: 45 Gy/25 fractions/5 weeks (1.8 Gy/fraction). , the inclusion criteria are as following:&#xD;
Age &lt; 18 years old.&#xD;
Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor histologic response to neo-adjuvant chemotherapy.&#xD;
Negative surgical margins.&#xD;
Patients show good safety profile and acceptable performance status.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Radiotherapy Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>this arm will not take radiotherapy and their inclusion criteria as following:&#xD;
Age &lt; 18 years old.&#xD;
Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor histologic response to neo-adjuvant chemotherapy.&#xD;
Negative surgical margins.&#xD;
Patients show good safety profile and acceptable performance status.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>External Beam Radiotherapy</intervention_name>
    <arm_group_label>Radiotherapy Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years old.&#xD;
&#xD;
          -  Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor&#xD;
             histologic response to neo-adjuvant chemotherapy.&#xD;
&#xD;
          -  Negative surgical margins.&#xD;
&#xD;
          -  Patients show good safety profile and acceptable performance status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who show progressive disease and undergo surgery before the time of local&#xD;
             control.&#xD;
&#xD;
          -  Patients who undergo Amputation or Rotationplasty will be excluded.&#xD;
&#xD;
          -  Post-surgical complications that may hinder the administration of radiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed s zaghloul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Cancer Hospital Egypt 57357</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Cancer Hospital Egypt 57357</name>
      <address>
        <city>Cairo</city>
        <zip>11441</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>January 11, 2016</last_update_submitted>
  <last_update_submitted_qc>January 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Sarcoma, Ewing</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/NCT01734863
org study id: CCHE-BoneT002
nct id: NCT01734863
lead sponsor: 
has dmc: Yes
Local recurrence after surgical resection is a complex phenomenon. An important predictive
      factor is the response to chemotherapy. Central site of disease may be a second independent
      predictive factor (Lin et al. 2007). Patients with more than 10% viable tumour cells at
      surgery following neo-adjuvant chemotherapy had a less favourable outcome with an Event-free
      Survival [EFS] of 47% after 10 years. Patients with good histological response (< 10% viable
      tumour cells) after chemotherapy alone had a prognosis of about 70% after 10 years.

      However, further studies are necessary to determine the merit of adjuvant radiation for
      high-risk patients (poor responders). Taking into consideration that the toxicity and
      morbidity of combined surgery and radiation is greater than either alone and must be closely
      monitored.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: improved Local Relapse-free Survival (LRFS)
time frame: five year event free survival
description: Determine whether the administration of post-operative radiotherapy for poor responder Ewing Sarcoma patients to neo-adjuvant chemotherapy and radical surgery, leads to improved Local Relapse-free Survival (LRFS).
arm group label: Radiotherapy Arm
arm group type: Experimental
description: this study arm will take External Beam radiotherapy as follows :
Radiotherapy Technique: Conformal radiotherapy, Intensity modulated radiotherapy [IMRT] is allowed.
Radiotherapy Dose: 45 Gy/25 fractions/5 weeks (1.8 Gy/fraction). , the inclusion criteria are as following:
Age < 18 years old.
Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor histologic response to neo-adjuvant chemotherapy.
Negative surgical margins.
Patients show good safety profile and acceptable performance status.
arm group label: No Radiotherapy Arm
arm group type: No Intervention
description: this arm will not take radiotherapy and their inclusion criteria as following:
Age < 18 years old.
Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor histologic response to neo-adjuvant chemotherapy.
Negative surgical margins.
Patients show good safety profile and acceptable performance status.
intervention type: Radiation
intervention name: External Beam Radiotherapy
arm group label: Radiotherapy Arm
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Mohamed s zaghloul, MD
role: Principal Investigator
affiliation: Children's Cancer Hospital Egypt 57357
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Sarcoma, Ewing