Clinical Trials /

Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma

NCT02225496

Description:

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.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma

Title

  • Brief Title: Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
  • Official Title: A Phase II Study of Transoral Robotic Surgery With Adjuvant Therapy for Surgically Resectable HPV-positive Oropharyngeal Cancer
  • Clinical Trial IDs

    NCT ID: NCT02225496

    ORG ID: 2013-0925

    NCI ID: NCI-2014-02126

    Trial Conditions

    Oropharyngeal Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    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.

    Detailed Description

    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.

    Trial Arms

    Name Type Description Interventions
    Transoral Robotic Surgery (TORS) Experimental 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.

    Eligibility Criteria

    Inclusion Criteria:

    1. Patients with a previously untreated, T1 or T2, N0-N2b transorally resectable (as
    determined by the treating surgeon), histologically proven HPV positive, squamous
    cell carcinoma (SCC) of the oropharynx.

    2. Eastern Cooperative Oncology Group (ECOG) PS 0-2.

    3. Age >/= 18 years.

    4. Negative serum pregnancy test in females of childbearing potential.

    5. Patients must sign a study-specific informed consent form prior to treatment.

    Exclusion Criteria:

    1. Evidence of distant metastases (below the clavicle) by clinical or radiographic
    examination.

    2. Evidence of any other primary cancers or metastases. Evidence of deep soft-tissue or
    bony invasion, which would preclude TMIS by clinical and/or radiographic exam.

    3. Contraindications to general anesthesia.

    4. Patients who have had chemotherapy or radiotherapy to the oropharynx prior to
    entering the study.

    5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
    infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
    arrhythmia, or psychiatric illness/social situations that would limit compliance with
    study requirements

    6. Patients with tumors whose resection would necessitate a free-tissue transfer for
    reconstruction of the surgical defect.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Local-Regional Recurrence Rate With Minimally-Invasive Transoral Robotic Surgery (TORS)

    Secondary Outcome Measures

    Trial Keywords

    Oropharyngeal cancer

    Oropharynx

    Human papilloma virus

    HPV positive

    Squamous cell carcinoma

    SCC

    Transoral robotic surgery

    TORS

    Intuitive Surgical da Vinci Surgical System

    Modified barium swallow

    MBS

    Questionnaires

    Surveys

    Speech and swallowing function