<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/NCT01681342</url>
  </required_header>
  <id_info>
    <org_study_id>BRACHY-HDR</org_study_id>
    <nct_id>NCT01681342</nct_id>
  </id_info>
  <brief_title>Sparing of Organs at Risk in High Dose Rate Brachytherapy</brief_title>
  <official_title>Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Oscar Lambret</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Oscar Lambret</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment&#xD;
      for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a&#xD;
      combination of external beam radiation therapy and intracavitary treatment. Low dose rate&#xD;
      intracavitary brachytherapy treatment is already well studied. But high dose rate&#xD;
      brachytherapy is a relatively new alternative.&#xD;
&#xD;
      In brachytherapy, major developments have been made in the integration of 3D imaging and&#xD;
      computerized 3D treatment planning. Medical imaging improvements allowed for better&#xD;
      definition of tumoral volumes and organs at risk.&#xD;
&#xD;
      The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of&#xD;
      these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of&#xD;
      volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis,&#xD;
      small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix&#xD;
      cancer. However its use is not easy in many brachytherapy departments.&#xD;
&#xD;
      This study will evaluate the feasibility and sparing of organs at risk for high dose rate&#xD;
      brachytherapy if volume delineation is done at each of the two sessions performed with 3D&#xD;
      RMN.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the&#xD;
      brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two&#xD;
      sessions.&#xD;
&#xD;
      A clinical examination and an RMN are performed at the end of the external radiation to&#xD;
      evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed.&#xD;
&#xD;
      During the first session, a CT-Scan and an RMN will be performed after the fletcher&#xD;
      application. A second CT-Scan will be performed during the second treatment session to create&#xD;
      new volumes and to improve organs at risk sparing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the sparing of organs at risk with a delineation at each session and the CTVhr volume modification</measure>
    <time_frame>At 8 weeks of external radiotherapy</time_frame>
    <description>To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of medical imaging with CT-Scan and RMN for cervix cancer</measure>
    <time_frame>At 8 weeks of external radiotherapy</time_frame>
    <description>Interest of RMN sequences Water and T2 for the definition of volumes&#xD;
Evaluation of imaging registration on the planning treatment system based on the brachytherapy applicator for the precision of volumes delineation&#xD;
Evaluate the interest of TDM and RMN for volumes delineation</description>
  </secondary_outcome>
  <enrollment type="Actual">24</enrollment>
  <condition>Cervical Carcinoma Stage IB to IV</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with indication of HDR brachytherapy in cervix carcinoma of stage IB to II.&#xD;
&#xD;
        After realization of external radiation therapy done (60 Gy in IMRT)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cervix carcinoma stage Ib to IV (FIGO)&#xD;
&#xD;
          -  OMS &lt; 2&#xD;
&#xD;
          -  Tomography by positron emission and/or chirurgical staging before the external&#xD;
             radiotherapy&#xD;
&#xD;
          -  RMN before the starting of treatment and at the end af external radiotherapy&#xD;
&#xD;
          -  Patient information&#xD;
&#xD;
          -  Validation of the indication af high dose rate brachytherapy&#xD;
&#xD;
          -  External radiation therapy (60 Gy with IMRT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No external radiation therapy&#xD;
&#xD;
          -  Surgery in the 4 weeks before before the inclusion&#xD;
&#xD;
          -  Prior pelvic radiation therapy&#xD;
&#xD;
          -  intestinal inflammatory disease or active pathology&#xD;
&#xD;
          -  active infection or severe pathology didn't allow the treatment&#xD;
&#xD;
          -  Prior carcinoma in the last 5 years (except cutaneous carcinoma or in situ carcinoma)&#xD;
&#xD;
          -  Inclusion in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Nickers, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Oscar Lambret</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>July 24, 2013</last_update_submitted>
  <last_update_submitted_qc>July 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stade Ib to IV cervix cancer</keyword>
  <keyword>ambulatory high dose rate brachytherapy</keyword>
  <!-- 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/NCT01681342
org study id: BRACHY-HDR
nct id: NCT01681342
lead sponsor: 
has dmc: No
Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment
      for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a
      combination of external beam radiation therapy and intracavitary treatment. Low dose rate
      intracavitary brachytherapy treatment is already well studied. But high dose rate
      brachytherapy is a relatively new alternative.

      In brachytherapy, major developments have been made in the integration of 3D imaging and
      computerized 3D treatment planning. Medical imaging improvements allowed for better
      definition of tumoral volumes and organs at risk.

      The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of
      these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of
      volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis,
      small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix
      cancer. However its use is not easy in many brachytherapy departments.

      This study will evaluate the feasibility and sparing of organs at risk for high dose rate
      brachytherapy if volume delineation is done at each of the two sessions performed with 3D
      RMN.
After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the
      brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two
      sessions.

      A clinical examination and an RMN are performed at the end of the external radiation to
      evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed.

      During the first session, a CT-Scan and an RMN will be performed after the fletcher
      application. A second CT-Scan will be performed during the second treatment session to create
      new volumes and to improve organs at risk sparing.
observational model: Case-Only
time perspective: Prospective
measure: Evaluation of the sparing of organs at risk with a delineation at each session and the CTVhr volume modification
time frame: At 8 weeks of external radiotherapy
description: To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.
measure: Evaluation of medical imaging with CT-Scan and RMN for cervix cancer
time frame: At 8 weeks of external radiotherapy
description: Interest of RMN sequences Water and T2 for the definition of volumes
Evaluation of imaging registration on the planning treatment system based on the brachytherapy applicator for the precision of volumes delineation
Evaluate the interest of TDM and RMN for volumes delineation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Philippe Nickers, MD, PhD
role: Study Director
affiliation: Centre Oscar Lambret
facility: 
country: France
responsible party type: Sponsor