<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/NCT01663753</url>
  </required_header>
  <id_info>
    <org_study_id>2011.670/13</org_study_id>
    <nct_id>NCT01663753</nct_id>
  </id_info>
  <brief_title>Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy</brief_title>
  <acronym>ERRICC</acronym>
  <official_title>Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and&#xD;
      brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment.&#xD;
      Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to&#xD;
      treatment before surgery. A positive predictive value of 75% was found in a small study&#xD;
      making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach.&#xD;
      Diffusion-weighted MRI was also described as an early and sensitive indicator in other&#xD;
      diseases.&#xD;
&#xD;
      Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in&#xD;
      the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary&#xD;
      objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted&#xD;
      MRI diagnostic performances.&#xD;
&#xD;
      Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2&#xD;
      cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a&#xD;
      18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the&#xD;
      brachytherapy. The total follow-up duration (study participation) of patients will be 11&#xD;
      weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until&#xD;
      18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.&#xD;
&#xD;
      Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to&#xD;
      assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it&#xD;
      could improve clinical practices and be helpful to decide whether the patient needs surgery&#xD;
      or not after radiochemotherapy and brachytherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy</measure>
    <time_frame>8 weeks</time_frame>
    <description>A centralized review will be carried out by 2 independant reviewers, additionally to the initial interpretation. The gold-standard to evaluate tumoral response to radiochemotherapy and brachytherapy will be the anatomopathologic analysis of the hysterectomy piece after surgery. The18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)and surgery will be performed within 3 weeks after the 18F-FDG-PET.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity and likehood ratios of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Cancer of the Uterine Cervix</condition>
  <arm_group>
    <arm_group_label>18F-FDG-PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>18F-FDG-PET</intervention_name>
    <arm_group_label>18F-FDG-PET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients 18 years of age or older&#xD;
&#xD;
          -  Biopsy-confirmed cervical squamous-cell carcinomas&#xD;
&#xD;
          -  Stage IB2, IIA ou IIB according to the FIGO staging of cervical carcinomas&#xD;
&#xD;
          -  No spread to lumbo-aortic lymph nodes&#xD;
&#xD;
          -  No prior pelvic radiotherapy&#xD;
&#xD;
          -  No prior cancer treatment&#xD;
&#xD;
          -  WHO Performance status less than or equal to 1&#xD;
&#xD;
          -  Beneficiary of a health insurance&#xD;
&#xD;
          -  Must provide her signed and informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reccurent or Metastasized cancer&#xD;
&#xD;
          -  History of uncontrolled cancer, or any cancer treated for less than 5 years (except&#xD;
             basal cell carcinomas)&#xD;
&#xD;
          -  Any contraindication to MRI&#xD;
&#xD;
          -  Know hypersensitivity to Gadolinium, 18F-FDG or one of the excipients&#xD;
&#xD;
          -  Pregnant or breast feeding patients&#xD;
&#xD;
          -  Participation in any other clinical trial that could interfere with the study results&#xD;
&#xD;
          -  Any geographical, social or psychical reasons that could prohibit the ability to&#xD;
             return for follow-up assessment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GOLFIER François, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Lyon Sud, Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Médecine Nucléaire, Institut de cancérologie de l'Ouest - Site Paul Papin</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Gynécologie Obstétrique, Hôpital Pellegrin, CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie Oncologique, Centre de Lutte Contre le Cancer Georges-François Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie Obstétrique, Hôpital Nord</name>
      <address>
        <city>Marseille</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie Gynécologique, Hôpital Arnaud de Villeneuve</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Radiothérapie, C.R.L.C. Val d'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie, Hôpital Archet II</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie, Hôpital Européen Georges Pompidou, APHP</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie Obstétrique, Hôpital Tenon, APHP</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie Gynécologique, Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75248</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie Obstétrique, CHU la Milétrie</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie Obstétrique, CHU Anne de Bretagne Hôpital Sud</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Département des Radiations, Centre Eugène Marquis</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie, Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie Gynécologique, Institut Curie - Hôpital René Huguenin</name>
      <address>
        <city>Saint-Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie Obstétrique, CHU St-Etienne</name>
      <address>
        <city>Saint-Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servce de Médecine Nucléaire, Centre René Gauducheau, CRLCC Nantes Atlantique</name>
      <address>
        <city>Saint-Herblain</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Département de Radiothérapie, Institut de Cancérologie de la Loire</name>
      <address>
        <city>Saint-Priest en Jarez</city>
        <zip>42271</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie Oncologique, Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Vandoeuvre lès Nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Médecine Nucléaire, Hôpital Brabois</name>
      <address>
        <city>Vandoeuvre-lès-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>2-fluoro-2-deoxy-d-glucose-positron emission tomography</keyword>
  <keyword>Positron emission tomography</keyword>
  <keyword>Magnetic resonance imaging</keyword>
  <keyword>Diffusion weighted MRI</keyword>
  <keyword>Squamous-cell cervical carcinoma</keyword>
  <keyword>Sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_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/NCT01663753
org study id: 2011.670/13
nct id: NCT01663753
lead sponsor: 
has dmc: No
Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and
      brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment.
      Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to
      treatment before surgery. A positive predictive value of 75% was found in a small study
      making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach.
      Diffusion-weighted MRI was also described as an early and sensitive indicator in other
      diseases.

      Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in
      the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary
      objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted
      MRI diagnostic performances.

      Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2
      cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a
      18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the
      brachytherapy. The total follow-up duration (study participation) of patients will be 11
      weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until
      18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.

      Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to
      assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it
      could improve clinical practices and be helpful to decide whether the patient needs surgery
      or not after radiochemotherapy and brachytherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
time frame: 8 weeks
description: A centralized review will be carried out by 2 independant reviewers, additionally to the initial interpretation. The gold-standard to evaluate tumoral response to radiochemotherapy and brachytherapy will be the anatomopathologic analysis of the hysterectomy piece after surgery. The18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)and surgery will be performed within 3 weeks after the 18F-FDG-PET.
measure: Specificity and likehood ratios of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
time frame: 8 weeks
measure: Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy
time frame: 8 weeks
arm group label: 18F-FDG-PET
arm group type: Experimental
description: The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)
intervention type: Device
intervention name: 18F-FDG-PET
arm group label: 18F-FDG-PET
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GOLFIER François, MD, PhD
role: Principal Investigator
affiliation: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Uterine Cervical Neoplasms
mesh term: Body Weight
mesh term: Fluorodeoxyglucose F18