<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/NCT02225496</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0925</org_study_id>
    <secondary_id>NCI-2014-02126</secondary_id>
    <nct_id>NCT02225496</nct_id>
  </id_info>
  <brief_title>Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma</brief_title>
  <official_title>A Phase II Study of Transoral Robotic Surgery With Adjuvant Therapy for Surgically Resectable HPV-positive Oropharyngeal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Standard-of-care treatment options for oropharyngeal cancer often result in long-term side&#xD;
      effects that interfere with normal quality of life. A minimally-invasive transoral robotic&#xD;
      surgery (TORS) approach has been developed to operate on the disease site while affecting the&#xD;
      surrounding tissue as little as possible. Researchers think that this approach may help to&#xD;
      control the disease and avoid such long-term side effects.&#xD;
&#xD;
      The goal of this clinical research study is to learn if minimally-invasive transoral robotic&#xD;
      surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through&#xD;
      the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System.&#xD;
&#xD;
      Researchers also want to learn if this surgery affects participants' ability to speak and&#xD;
      swallow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Surgery:&#xD;
&#xD;
      If you are found to be eligible to take part in this study, you will be scheduled for&#xD;
      surgery. You will receive general anesthesia to make you sleep during the procedure. You will&#xD;
      be asked to sign a separate consent form that describes the anesthesia and its risks. If the&#xD;
      doctor thinks it is needed, the abnormal area will be looked at with a tube that has a&#xD;
      lighted camera on one end (called a laryngoscopy) to check the size of the tumor and to look&#xD;
      for any additional cancerous areas.&#xD;
&#xD;
      The tumor will be exposed with standard equipment after the teeth are protected with a dental&#xD;
      guard. Using the robotic surgical system, the tumor will be removed.&#xD;
&#xD;
      Your affected lymph nodes will be surgically removed through your neck. The robotic system&#xD;
      will not be used for that part of the surgery. The nerve that controls the shoulder, the&#xD;
      blood vessel that brings blood back to the heart from the brain and neck, and the major&#xD;
      muscle of the front of the neck will all be saved, unless the tumor in the lymph nodes has&#xD;
      grown directly into those areas. A drain will be placed before the surgical wound is closed.&#xD;
      The drain will usually be removed within a week after surgery.&#xD;
&#xD;
      Based on the results of surgery, you will receive adjuvant therapy (therapy after the&#xD;
      surgery). For example, if your surgery does not remove enough of the cancer, you will be&#xD;
      referred to receive radiation therapy. There will likely need to be a 1-2 week delay before&#xD;
      you can receive radiation therapy. Your doctor will discuss this therapy with you in more&#xD;
      detail, including the risks.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      The surgery will be stopped if the doctor thinks the tumor is too large to be removed with&#xD;
      the robotic system. You will be taken off study if you are unable to follow study directions.&#xD;
&#xD;
      Your participation on the study will be over after the follow-up visits and data collection.&#xD;
&#xD;
      Follow-Up Visits:&#xD;
&#xD;
      Within 1-4 weeks after surgery (+/- 3 days):&#xD;
&#xD;
        -  You will have a physical exam, including a cranial nerve exam of your tongue, palate,&#xD;
           and facial nerves.&#xD;
&#xD;
        -  You will have an MBS.&#xD;
&#xD;
        -  You will meet with a speech pathologist.&#xD;
&#xD;
        -  You will complete the questionnaires about your speech and swallowing function.&#xD;
&#xD;
      At 6 months (+/- 2 months), 12 months (+/- 2 months), and 24 months (+/- 6 months) after&#xD;
      surgery:&#xD;
&#xD;
        -  You will have an MBS.&#xD;
&#xD;
        -  You will have a cranial nerve exam of your tongue, palate, and facial nerves.&#xD;
&#xD;
        -  You will meet with a speech pathologist.&#xD;
&#xD;
        -  You will complete the questionnaires about your speech and swallowing function.&#xD;
&#xD;
      As often as the doctor thinks it is needed for up to 5 years after surgery, the study staff&#xD;
      will check your medical record to find out how you are doing and about any treatments and&#xD;
      follow-up you have had.&#xD;
&#xD;
      This is an investigational study. The robotic surgical procedure (the daVinci Surgical&#xD;
      System) is FDA approved and commercially available. The study doctor can explain how the&#xD;
      surgery is designed to work.&#xD;
&#xD;
      Up to 150 participants will be enrolled in this study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Another trial in the department directly competes for the the same patient population&#xD;
  </why_stopped>
  <start_date type="Actual">September 23, 2014</start_date>
  <completion_date type="Actual">December 8, 2017</completion_date>
  <primary_completion_date type="Actual">December 8, 2017</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to local-regional recurrence (TTLRR)</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Primary efficacy endpoint is time to local-regional recurrence (TTLRR). TTLRR measured from surgery (using minimally-invasive Transoral Robotic Surgery (TORS)) date to first date that local-regional recurrence disease is objectively documented or to last follow-up date if local-regional recurrence has not occurred during follow-up.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Oropharyngeal Cancer</condition>
  <arm_group>
    <arm_group_label>Transoral Robotic Surgery (TORS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm. Functional assessment performed at pre-treatment, within 1-4 weeks post-op from TORS (before adjuvant therapy), and after completion of treatment at the following time points: 6 months (±2 months), 12 months (±2 months), and 24 months (±6 months). Functional measures include video-fluoroscopic examination of swallowing (modified barium swallow [MBS] study) with administration of the Performance Status Scale-Head and Neck (PSS-HN) and MD Anderson Dysphagia Inventory (MDADI) questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transoral Robotic Surgery (TORS)</intervention_name>
    <description>Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm.</description>
    <arm_group_label>Transoral Robotic Surgery (TORS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Modified Barium Swallow (MBS)</intervention_name>
    <description>MBS performed at baseline and 1 - 4 weeks after surgery, and at 6 months, 12 months and 24 months.</description>
    <arm_group_label>Transoral Robotic Surgery (TORS)</arm_group_label>
    <other_name>MBS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Questionnaires about speech and swallowing function completed at baseline, 1 - 4 weeks after surgery, and at 6 months, 12 months, and at 24 months.</description>
    <arm_group_label>Transoral Robotic Surgery (TORS)</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with a previously untreated, T1 or T2, N0-N2b transorally resectable (as&#xD;
             determined by the treating surgeon), histologically proven HPV positive, squamous cell&#xD;
             carcinoma (SCC) of the oropharynx.&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) PS 0-2.&#xD;
&#xD;
          3. Age &gt;/= 18 years.&#xD;
&#xD;
          4. Negative serum pregnancy test in females of childbearing potential.&#xD;
&#xD;
          5. Patients must sign a study-specific informed consent form prior to treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of distant metastases (below the clavicle) by clinical or radiographic&#xD;
             examination.&#xD;
&#xD;
          2. Evidence of any other primary cancers or metastases. Evidence of deep soft-tissue or&#xD;
             bony invasion, which would preclude TMIS by clinical and/or radiographic exam.&#xD;
&#xD;
          3. Contraindications to general anesthesia.&#xD;
&#xD;
          4. Patients who have had chemotherapy or radiotherapy to the oropharynx prior to entering&#xD;
             the study.&#xD;
&#xD;
          5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          6. Patients with tumors whose resection would necessitate a free-tissue transfer for&#xD;
             reconstruction of the surgical defect.&#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>Michael E. Kupferman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oropharyngeal cancer</keyword>
  <keyword>Oropharynx</keyword>
  <keyword>Human papilloma virus</keyword>
  <keyword>HPV positive</keyword>
  <keyword>Squamous cell carcinoma</keyword>
  <keyword>SCC</keyword>
  <keyword>Transoral robotic surgery</keyword>
  <keyword>TORS</keyword>
  <keyword>Intuitive Surgical da Vinci Surgical System</keyword>
  <keyword>Modified barium swallow</keyword>
  <keyword>MBS</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <keyword>Speech and swallowing function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oropharyngeal Neoplasms</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/NCT02225496
org study id: 2013-0925
secondary id: NCI-2014-02126
nct id: NCT02225496
lead sponsor: 
has dmc: No
Standard-of-care treatment options for oropharyngeal cancer often result in long-term side
      effects that interfere with normal quality of life. A minimally-invasive transoral robotic
      surgery (TORS) approach has been developed to operate on the disease site while affecting the
      surrounding tissue as little as possible. Researchers think that this approach may help to
      control the disease and avoid such long-term side effects.

      The goal of this clinical research study is to learn if minimally-invasive transoral robotic
      surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through
      the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System.

      Researchers also want to learn if this surgery affects participants' ability to speak and
      swallow.
Study Surgery:

      If you are found to be eligible to take part in this study, you will be scheduled for
      surgery. You will receive general anesthesia to make you sleep during the procedure. You will
      be asked to sign a separate consent form that describes the anesthesia and its risks. If the
      doctor thinks it is needed, the abnormal area will be looked at with a tube that has a
      lighted camera on one end (called a laryngoscopy) to check the size of the tumor and to look
      for any additional cancerous areas.

      The tumor will be exposed with standard equipment after the teeth are protected with a dental
      guard. Using the robotic surgical system, the tumor will be removed.

      Your affected lymph nodes will be surgically removed through your neck. The robotic system
      will not be used for that part of the surgery. The nerve that controls the shoulder, the
      blood vessel that brings blood back to the heart from the brain and neck, and the major
      muscle of the front of the neck will all be saved, unless the tumor in the lymph nodes has
      grown directly into those areas. A drain will be placed before the surgical wound is closed.
      The drain will usually be removed within a week after surgery.

      Based on the results of surgery, you will receive adjuvant therapy (therapy after the
      surgery). For example, if your surgery does not remove enough of the cancer, you will be
      referred to receive radiation therapy. There will likely need to be a 1-2 week delay before
      you can receive radiation therapy. Your doctor will discuss this therapy with you in more
      detail, including the risks.

      Length of Study:

      The surgery will be stopped if the doctor thinks the tumor is too large to be removed with
      the robotic system. You will be taken off study if you are unable to follow study directions.

      Your participation on the study will be over after the follow-up visits and data collection.

      Follow-Up Visits:

      Within 1-4 weeks after surgery (+/- 3 days):

        -  You will have a physical exam, including a cranial nerve exam of your tongue, palate,
           and facial nerves.

        -  You will have an MBS.

        -  You will meet with a speech pathologist.

        -  You will complete the questionnaires about your speech and swallowing function.

      At 6 months (+/- 2 months), 12 months (+/- 2 months), and 24 months (+/- 6 months) after
      surgery:

        -  You will have an MBS.

        -  You will have a cranial nerve exam of your tongue, palate, and facial nerves.

        -  You will meet with a speech pathologist.

        -  You will complete the questionnaires about your speech and swallowing function.

      As often as the doctor thinks it is needed for up to 5 years after surgery, the study staff
      will check your medical record to find out how you are doing and about any treatments and
      follow-up you have had.

      This is an investigational study. The robotic surgical procedure (the daVinci Surgical
      System) is FDA approved and commercially available. The study doctor can explain how the
      surgery is designed to work.

      Up to 150 participants will be enrolled in this study. All will be enrolled at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to local-regional recurrence (TTLRR)
time frame: 6 months after surgery
description: Primary efficacy endpoint is time to local-regional recurrence (TTLRR). TTLRR measured from surgery (using minimally-invasive Transoral Robotic Surgery (TORS)) date to first date that local-regional recurrence disease is objectively documented or to last follow-up date if local-regional recurrence has not occurred during follow-up.
arm group label: Transoral Robotic Surgery (TORS)
arm group type: Experimental
description: Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm. Functional assessment performed at pre-treatment, within 1-4 weeks post-op from TORS (before adjuvant therapy), and after completion of treatment at the following time points: 6 months (±2 months), 12 months (±2 months), and 24 months (±6 months). Functional measures include video-fluoroscopic examination of swallowing (modified barium swallow [MBS] study) with administration of the Performance Status Scale-Head and Neck (PSS-HN) and MD Anderson Dysphagia Inventory (MDADI) questionnaire.
intervention type: Procedure
intervention name: Transoral Robotic Surgery (TORS)
description: Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm.
arm group label: Transoral Robotic Surgery (TORS)
intervention type: Procedure
intervention name: Modified Barium Swallow (MBS)
description: MBS performed at baseline and 1 - 4 weeks after surgery, and at 6 months, 12 months and 24 months.
arm group label: Transoral Robotic Surgery (TORS)
other name: MBS
intervention type: Behavioral
intervention name: Questionnaires
description: Questionnaires about speech and swallowing function completed at baseline, 1 - 4 weeks after surgery, and at 6 months, 12 months, and at 24 months.
arm group label: Transoral Robotic Surgery (TORS)
other name: Surveys
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael E. Kupferman, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Oropharyngeal Neoplasms