<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/NCT03010553</url>
  </required_header>
  <id_info>
    <org_study_id>2007-A00922-51</org_study_id>
    <secondary_id>2006/1217</secondary_id>
    <nct_id>NCT03010553</nct_id>
  </id_info>
  <brief_title>Multicenter Phase II Study of Sentinel Node Detection in Squamous Cell Carcinoma T1-T2N0 of the Oropharynx Treated With Radiotherapy and Larynx Treated by Surgery, Laser or Robot</brief_title>
  <acronym>GS-OROPHARYNX</acronym>
  <official_title>Multicenter Phase II Study of Sentinel Node Detection in Squamous Cell Carcinoma T1-T2N0 of the Oropharynx Treated With Radiotherapy and Larynx Treated by Surgery, Laser or Robot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a&#xD;
      99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along&#xD;
      with the other lymph nodes of the selective group II and III recess. Sentinel lymph node&#xD;
      staging alone and complete dissection with routine anatomical pathology will be compared If&#xD;
      this technique is reliable it will make a therapeutic de-escalation in the treatment of small&#xD;
      tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel node&#xD;
      is free from metastasis and also to better choose the treatment in case of lymph node&#xD;
      involvement&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2008</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reliability of the sentinel lymph node technique</measure>
    <time_frame>Up to 24 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Oropharynx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tumors of the oropharynx T1T2N0 treated with radiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Larynx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tumors of the T1T2N0 larynx treated by surgery, laser or robot</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Detection and resection of sentinel lymph node</intervention_name>
    <arm_group_label>Larynx</arm_group_label>
    <arm_group_label>Oropharynx</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Squamous cell carcinoma T1 or T2 of the oropharynx or larynx, clinical and computed&#xD;
             tomography, M0,&#xD;
&#xD;
          2. previously untreated patient, without further concomitant localization,&#xD;
&#xD;
          3. patient over age 18 with no upper age limit, general condition WHO 0 or 1, life&#xD;
             expectancy greater than 2 years,&#xD;
&#xD;
          4. on the cervical tomodensitometric assessment with injection of contrast agent: absence&#xD;
             of adenomegaly suspicious of metastasis = ganglion of size less than one centimeter&#xD;
             and 1.5 cm for group IIa, ovoid, homogeneous, not taking the contrast product And no&#xD;
             signs of peri-ganglion invasion (fatty hyperdensity, vascular adhesion), absence of&#xD;
             ganglionic grouping (&gt; 3)&#xD;
&#xD;
          5. Untreated patient outside a biopsy excision (melanoma experiment),&#xD;
&#xD;
          6. Possibility of realizing an IMRT&#xD;
&#xD;
          7. Informing the patient and signing informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Patient already treated for this tumor outside a biopsy excision, 2) Contraindications&#xD;
        to radiotherapy, scintigraphy or procedure, allergy to Rhenium sulphide or 99m Technetium&#xD;
        3) History of epidermoid carcinoma of VADS 4) Pregnant woman, likely to be pregnant or&#xD;
        nursing, (5) Persons deprived of their liberty or under guardianship, 6) Impossibility to&#xD;
        submit to the medical follow-up of the trial for geographical, social or psychological&#xD;
        reasons.&#xD;
&#xD;
        7) Patient who underwent cervical surgery for any cause 8) Patient with cervical&#xD;
        radiotherapy 9) Patient unable to undergo cervical lymph node dissection 10) Patient&#xD;
        treated for another cancer outside the VADS within a period of less than 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Antoine MOYA PLANA, MD</last_name>
    <phone>0142114603</phone>
    <phone_ext>+33</phone_ext>
    <email>antoine.moyaplana@gustaveroussy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val de Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine MOYA PLANA, MD</last_name>
      <phone>0142114603</phone>
      <phone_ext>+33</phone_ext>
      <email>antoine.moyaplana@gustaveroussy.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</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>Carcinoma, Squamous Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03010553
org study id: 2007-A00922-51
secondary id: 2006/1217
nct id: NCT03010553
lead sponsor: 
has dmc: No
Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a
      99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along
      with the other lymph nodes of the selective group II and III recess. Sentinel lymph node
      staging alone and complete dissection with routine anatomical pathology will be compared If
      this technique is reliable it will make a therapeutic de-escalation in the treatment of small
      tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel node
      is free from metastasis and also to better choose the treatment in case of lymph node
      involvement
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reliability of the sentinel lymph node technique
time frame: Up to 24 months
arm group label: Oropharynx
arm group type: Experimental
description: Tumors of the oropharynx T1T2N0 treated with radiotherapy
arm group label: Larynx
arm group type: Experimental
description: Tumors of the T1T2N0 larynx treated by surgery, laser or robot
intervention type: Procedure
intervention name: Detection and resection of sentinel lymph node
arm group label: Larynx
arm group label: Oropharynx
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antoine MOYA PLANA, MD
phone: 0142114603
phone ext: +33
email: antoine.moyaplana@gustaveroussy.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma, Squamous Cell
sharing ipd: No