<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/NCT02984410</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1420-HNCG-ROG</org_study_id>
    <nct_id>NCT02984410</nct_id>
  </id_info>
  <brief_title>Study Assessing The &quot;Best of&quot; Radiotherapy vs the &quot;Best of&quot; Surgery in Patients With Oropharyngeal Carcinoma</brief_title>
  <acronym>Best Of</acronym>
  <official_title>Phase III Study Assessing the &quot;Best of&quot; Radiotherapy Compared to the &quot;Best of&quot; Surgery (Trans-oral Surgery (TOS)) in Patients With T1-T2, N0-N1 Oropharyngeal, Supraglottic Carcinoma and With T1, N0 Hypopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</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>
      Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of&#xD;
      tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are&#xD;
      usually cured. Treatment of early stage OPSCC can be successfully achieved with primary&#xD;
      surgery including neck dissection, as indicated, or with definitive radiotherapy. The current&#xD;
      standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both&#xD;
      associated with comparable, high tumor control rates but with different side effects profiles&#xD;
      and technical constraints.&#xD;
&#xD;
      In order to decrease the potential morbidity of surgery, transoral approaches have been&#xD;
      developed within the last decades, including transoral robotic surgery (TORS), transoral&#xD;
      laser microsurgery (TLM) or conventional transoral techniques. On the other hand, patients&#xD;
      with head and neck cancer treated with IMRT experienced significant improvements in cause&#xD;
      specific survival (CSS) compared with patients treated with non-IMRT techniques thus&#xD;
      suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile.&#xD;
      It is as yet unclear however, which one of the new techniques is superior to the other in&#xD;
      terms of function preservation. Given that the functional outcome of most importance is&#xD;
      swallowing function, the preservation of swallowing is thus of major importance.&#xD;
&#xD;
      The main objective of the study is to assess and compare the patient-reported swallowing&#xD;
      function over the first year after randomization to either IMRT or TOS among patients with&#xD;
      early stage OPSCC, SGSCC, and HPSCC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will be randomized 1 to 1 to surgery (Arm 1) or radiotherapy (Arm 2).&#xD;
&#xD;
      ARM 1: Surgery&#xD;
&#xD;
      Trans-oral surgery (any trans-oral approach such as trans-oral laser microsurgery&#xD;
      conventional trans-oral surgery or trans-oral robotic surgery) will be applied to all&#xD;
      patients in this arm.&#xD;
&#xD;
      A surgical margin is defined to be clear (R0), if found to be &gt;/=3mm in the final specimen&#xD;
      (except deep margin for tonsillar resection, that is either R1 or R0), is defined to be&#xD;
      close, if 1-&lt;3mm, and considered to be involved (R1), if &lt;1mm in the final specimen. Clearly&#xD;
      defined marginal biopsies are required for each TOS-technique. Trans-oral re-resections are&#xD;
      required in case of R1 or close-margin to convert the patient to an R0-status.Postoperative&#xD;
      RT or chemo-RT will be given within 5-6 weeks of surgery in case of positive.&#xD;
&#xD;
      ARM 2: Radiotherapy&#xD;
&#xD;
      Intensity modulated radiation therapy (IMRT) with Simultaneous integrated boost (SIB) will be&#xD;
      applied to all patients in this arm. PTV prescription to tumor and high risk areas will be&#xD;
      delivered daily for 5 days per week to a total dose of 66-70Gy in 2 Gy/fraction over 6 weeks,&#xD;
      elective/prophylactic mucosal and nodal areas will receive a total dose of 54.25- 54.45 Gy in&#xD;
      33-35 fractions of 1.55-1.65 Gy over 6 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Anticipated">September 2029</completion_date>
  <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
  <phase>N/A</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>Change in the MD Anderson Dysphagia Inventory (MDADI) score</measure>
    <time_frame>at 4.5 and 12 months after randomization</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Oropharyngeal Cancer</condition>
  <condition>Supraglottic Squamous Cell Carcinoma</condition>
  <condition>Hypopharyngeal Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Intensity-Modulated Radiation Therapy (IMRT)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>PTV prescription to tumor and high risk areas will be delivered daily for 5 days per week to a total dose of 66-70Gy in 2 Gy/fraction over 6 weeks, elective/prophylactic mucosal and nodal areas will receive a total dose of 54.25- 54.45 Gy in 33-35 fractions of 1.55-1.65 Gy over 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trans Oral Surgery (TOS)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The following surgical techniques are allowed:&#xD;
Transoral Robotic Surgery (TORS) Transoral Microsurgery (TLM) Conventional trans-oral Surgery (CTOS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity-Modulated Radiation Therapy (IMRT)</intervention_name>
    <description>IMRT (Simultaneous Integrated Boost (SIB) and accelerated regimen) with selective neck node dissection</description>
    <arm_group_label>Intensity-Modulated Radiation Therapy (IMRT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trans Oral Surgery (TOS)</intervention_name>
    <description>TOS (Trans Oral Laser Microsurgery (TLM), Trans Oral Robotic Surgery (TORS), conventional) with selective neck node dissection</description>
    <arm_group_label>Trans Oral Surgery (TOS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  OPSCC in one of the following sub-sites: base of tongue, lateral pharyngeal wall,&#xD;
             tonsil, glosso-tonsillar sulcus, vallecula or SGSCC in one or more of the following&#xD;
             sub-sites: epiglottis, aryepiglottic fold, false cord or HPSCC in one or more of the&#xD;
             following subsites: Lateral and medial wall of piriform sinus (sub-sites are defined&#xD;
             as lateral (lateral pharyngeal wall, tonsil, glosso-tonsillar sulcus, lateral piriform&#xD;
             sinus) vs. central lesions (base of tongue, vallecula, all supraglottic sites, medial&#xD;
             wall of piriform sinus))&#xD;
&#xD;
          -  TNM stage I-III (7th AJCC classification): T1 or T2, N0 or T1 or T2, N1 with one&#xD;
             single neck node ≤ 3cm without radiographic signs of extracapsular extension (ECE),&#xD;
             M0;&#xD;
&#xD;
          -  TNM stage I for HPSCC: T1, N0, M0. ;&#xD;
&#xD;
          -  Within 2 weeks before randomization, assessment by a Multi-Disciplinary Team (MDT)&#xD;
             composed of at least a head and neck/ENT surgeon, oncologist, radiologist,&#xD;
             radiotherapist, and pathologist of the treatment naïve patient and suitable for either&#xD;
             TOS or IMRT based on:&#xD;
&#xD;
          -  CT with contrast and/or MRI done within 4 weeks prior to randomization Note: Repeat&#xD;
             contrast enhanced CT and/or MRI or US 1 week or less prior to randomization in case of&#xD;
             suspicious nodes &lt;1cm on initial scan if per local practice&#xD;
&#xD;
          -  Pan-endoscopy with assessment of trans-oral exposure for resection.&#xD;
&#xD;
          -  peri-nodal infiltration either via CT-scan or MRI.&#xD;
&#xD;
          -  Age 18 and older; Age 18 to 70 for SGSCC&#xD;
&#xD;
          -  ECOG Performance status ≤ 2;&#xD;
&#xD;
          -  Availability of biological material for HPV/p16 testing for OPSCCs&#xD;
&#xD;
          -  Study information and Informed consent discussed by the surgeon and radio-oncologist&#xD;
             and signed by the patient.&#xD;
&#xD;
          -  Within 2 weeks prior randomization:&#xD;
&#xD;
          -  Baseline MDADI score available;&#xD;
&#xD;
          -  Adequate bone marrow function as demonstrated by neutrophils count &gt; 1,5 109 /L ,&#xD;
             platelets count &gt; 75 109 /L, WBC≥ 3.0 109 /L;&#xD;
&#xD;
          -  Prothrombin time (PT) with an international normalized ratio (INR) ≤ 1.2&#xD;
&#xD;
          -  Partial thromboplastin time (PTT) ≤ 1.2 times ULN&#xD;
&#xD;
          -  Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy&#xD;
             test no more than 72 hours prior to randomization.&#xD;
&#xD;
          -  Patients of childbearing / reproductive potential should agree to use adequate birth&#xD;
             control measures for 3 months, especially if they will undergo any radiotherapy&#xD;
             treatment at any time during the study. A highly effective method of birth control is&#xD;
             defined as those which result in low failure rate (i.e. less than 1% per year) when&#xD;
             used consistently and correctly.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Any previous anti-cancer therapy for HNSCC (surgery, chemo-, or radiotherapy or&#xD;
             molecular targeted therapy);&#xD;
&#xD;
          -  Any active malignancy (other than non-melanoma skin cancer or localized cervical&#xD;
             cancer or localized and presumed cured prostatic cancer) within the last 5 years with&#xD;
             ongoing systemic treatment&#xD;
&#xD;
          -  Cancer in contact with the internal and/or common carotid artery&#xD;
&#xD;
          -  Extension of OPSCC across the midline of the base-of-tongue&#xD;
&#xD;
          -  Arytenoid involvement in case of SGSCC&#xD;
&#xD;
          -  Infiltration of apex for piriform sinus in case of HPSCC&#xD;
&#xD;
          -  Cancer originating from the soft palate or posterior pharyngeal wall&#xD;
&#xD;
          -  Requirement of a reconstruction with a free or regional flap (i.e. involvement of &gt;50%&#xD;
             of the soft palate)&#xD;
&#xD;
          -  Pre-existing dysphagia not related to the oropharyngeal cancer or diagnostic biopsies&#xD;
&#xD;
          -  Any psychological, cognitive, familial, sociological or geographical condition&#xD;
             potentially hampering compliance with the study protocol, completion of patient&#xD;
             reported measures and follow-up schedule; those conditions should be discussed with&#xD;
             the patient before registration in the trial&#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_official>
    <last_name>Christian Simon</last_name>
    <role>Study Chair</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>EORTC HQ</last_name>
    <phone>+32 2 774 16 11</phone>
    <email>eortc@eortc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU-UCL Namur - CHU Mont Godinne</name>
      <address>
        <city>Namur</city>
        <state>Yvoir</state>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sébastien Van Der Vorst, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sandra Schmitz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet-Hopital Universitaire ULB</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Esther Willemse, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>U.Z. Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sandra Nuyts, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Strasbourg - Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Philippe Schultz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitaetklinikum Halle - Martin Luther Universitaet</name>
      <address>
        <city>Halle</city>
        <zip>06129</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Frank Peter Sieker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ulrich Kisser, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitaets Krankenhaus Eppendorf - UKE - University Cancer Center</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christian Betz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cordula Petersen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Andrea Wittig, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Orlando Guntinas-Lichius, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Koeln</name>
      <address>
        <city>Koeln</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jens Peter Klussmann, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian Baues, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Staedtisches Klinikum Leipzig - Klinikum St Georg</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Rechts der isar Der Technische Universitaet Muenchen</name>
      <address>
        <city>Muenchen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Benedikt Hofauer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Steffi Pigorsch, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Tuebingen- Crona Kliniken</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Simon Boeke, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul-Stefan Mauz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm-Michelsberg-HNO</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Thomas Hoffmann, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Weigel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Giuseppe Spriano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mohssen Ansarin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Great Poland Cancer Centre</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Wojciech Golusinski, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Donostia</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Jon Alexander Sistiaga Suarez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Rafael Barbera, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central De Asturias</name>
      <address>
        <city>Oviedo</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Fernando Lopez Alvarez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitaetsspital Basel</name>
      <address>
        <city>Basel</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Frank Zimmermann, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Roland Giger, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois - Lausanne</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Chistian Simon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UniversitaetsSpital Zurich - Klinik fur Ohren, Hals und Gesichtschirurgie</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Martina Anja Broglie Daeppen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Matthew Beasley, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospital NHS - Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ekpemi Irune, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiff and Vale University Health Board - University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sandeep Berry, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital</name>
      <address>
        <city>Cottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Lorcan O Tool, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aintree University Hospital NHS Trust</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Terry Jones, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation trust - Guy s and St Thomas' NHS - Guy's Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Asit Arora, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust - Charing Cross Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zaid Awad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>South Tees Hospitals NHS Foundation Trust - The James Cook University Hospital</name>
      <address>
        <city>Middlesbrough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Shane Lester, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T1-T2, N0-N1 oropharyngeal carcinoma, supraglottic carcinoma, T1, N0 hypopharyngeal carcinoma</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>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</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/NCT02984410
org study id: EORTC-1420-HNCG-ROG
nct id: NCT02984410
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of
      tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are
      usually cured. Treatment of early stage OPSCC can be successfully achieved with primary
      surgery including neck dissection, as indicated, or with definitive radiotherapy. The current
      standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both
      associated with comparable, high tumor control rates but with different side effects profiles
      and technical constraints.

      In order to decrease the potential morbidity of surgery, transoral approaches have been
      developed within the last decades, including transoral robotic surgery (TORS), transoral
      laser microsurgery (TLM) or conventional transoral techniques. On the other hand, patients
      with head and neck cancer treated with IMRT experienced significant improvements in cause
      specific survival (CSS) compared with patients treated with non-IMRT techniques thus
      suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile.
      It is as yet unclear however, which one of the new techniques is superior to the other in
      terms of function preservation. Given that the functional outcome of most importance is
      swallowing function, the preservation of swallowing is thus of major importance.

      The main objective of the study is to assess and compare the patient-reported swallowing
      function over the first year after randomization to either IMRT or TOS among patients with
      early stage OPSCC, SGSCC, and HPSCC.
Eligible patients will be randomized 1 to 1 to surgery (Arm 1) or radiotherapy (Arm 2).

      ARM 1: Surgery

      Trans-oral surgery (any trans-oral approach such as trans-oral laser microsurgery
      conventional trans-oral surgery or trans-oral robotic surgery) will be applied to all
      patients in this arm.

      A surgical margin is defined to be clear (R0), if found to be >/=3mm in the final specimen
      (except deep margin for tonsillar resection, that is either R1 or R0), is defined to be
      close, if 1-<3mm, and considered to be involved (R1), if <1mm in the final specimen. Clearly
      defined marginal biopsies are required for each TOS-technique. Trans-oral re-resections are
      required in case of R1 or close-margin to convert the patient to an R0-status.Postoperative
      RT or chemo-RT will be given within 5-6 weeks of surgery in case of positive.

      ARM 2: Radiotherapy

      Intensity modulated radiation therapy (IMRT) with Simultaneous integrated boost (SIB) will be
      applied to all patients in this arm. PTV prescription to tumor and high risk areas will be
      delivered daily for 5 days per week to a total dose of 66-70Gy in 2 Gy/fraction over 6 weeks,
      elective/prophylactic mucosal and nodal areas will receive a total dose of 54.25- 54.45 Gy in
      33-35 fractions of 1.55-1.65 Gy over 6 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the MD Anderson Dysphagia Inventory (MDADI) score
time frame: at 4.5 and 12 months after randomization
arm group label: Intensity-Modulated Radiation Therapy (IMRT)
arm group type: Other
description: PTV prescription to tumor and high risk areas will be delivered daily for 5 days per week to a total dose of 66-70Gy in 2 Gy/fraction over 6 weeks, elective/prophylactic mucosal and nodal areas will receive a total dose of 54.25- 54.45 Gy in 33-35 fractions of 1.55-1.65 Gy over 6 weeks.
arm group label: Trans Oral Surgery (TOS)
arm group type: Other
description: The following surgical techniques are allowed:
Transoral Robotic Surgery (TORS) Transoral Microsurgery (TLM) Conventional trans-oral Surgery (CTOS)
intervention type: Radiation
intervention name: Intensity-Modulated Radiation Therapy (IMRT)
description: IMRT (Simultaneous Integrated Boost (SIB) and accelerated regimen) with selective neck node dissection
arm group label: Intensity-Modulated Radiation Therapy (IMRT)
intervention type: Procedure
intervention name: Trans Oral Surgery (TOS)
description: TOS (Trans Oral Laser Microsurgery (TLM), Trans Oral Robotic Surgery (TORS), conventional) with selective neck node dissection
arm group label: Trans Oral Surgery (TOS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Simon
role: Study Chair
affiliation: Centre Hospitalier Universitaire Vaudois
last name: EORTC HQ
phone: +32 2 774 16 11
email: eortc@eortc.org
facility: 
status: Recruiting
investigator: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
investigator: 
country: Belgium
country: France
country: Germany
country: Italy
country: Poland
country: Spain
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Oropharyngeal Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck