Clinical Trials /

Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

NCT03224000

Description:

The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer. This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational. Up to 75 participants will be enrolled in this study. All will take part at MD Anderson.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
  • Official Title: Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Clinical Trial IDs

  • ORG STUDY ID: 2015-0851
  • SECONDARY ID: NCI-2018-01109
  • NCT ID: NCT03224000

Conditions

  • Malignant Neoplasms of Lip Oral Cavity and Pharynx
  • Oropharyngeal Cancer

Purpose

The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer. This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational. Up to 75 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed Description

      Baseline Visit:

      If you are found to be eligible to take part in this study and agree, you will have a
      baseline visit. The following tests and procedures will be performed:

        -  You will have a hearing test.

        -  You will have a dental exam. During this exam, your saliva flow will be measured and you
           will be checked for lockjaw.

        -  Your swallowing function will be tested with a special type of x-ray called a modified
           barium swallow (MBS). During the test, you will eat and drink foods and liquids mixed
           with a "contrast" chemical called barium that will make your throat more visible in the
           x-rays. A special x-ray tube will be connected to a television screen to allow the
           doctor to watch the foods and liquids pass from your mouth and down your throat.

        -  You will complete a questionnaire about swallowing that should take about 5 minutes to
           complete.

        -  You will have a video-strobe procedure to check your vocal cords. To perform a
           video-strobe procedure, a small camera will be inserted into the throat through your
           nose or mouth. You will be awake for this procedure and the study staff will give you
           the option of receiving a numbing spray for your nose and/or throat.

        -  Photos of the inside of your mouth will be taken to check for mouth sores.

        -  You will fill out questionnaires about your quality of life, work status, medical
           history, smoking status, and any symptoms you may have. Completing these questionnaires
           should take about 10-15 minutes.

      Study Groups:

      If you are among the first 15 patients enrolled in the study, you will be in Group 1.

      If you join the study after the first 15 patients have enrolled, you will be randomly
      assigned (as a flip of a coin) to 1 of 2 study groups. This is done because no one knows if
      one study group is better, the same, or worse than the other group.

        -  If you are in Group 1, an MRI will be used to plan your IMRT.

        -  If you are in Group 2, you will receive standard-of-care IMRT.

      Length of Study Participation:

      No matter which group you are in, you may continue receiving radiation therapy for up to 6 ½
      weeks. You will no longer be able to take part in this study if the disease gets worse, if
      intolerable side effects occur, or if you are unable to follow study directions.

      Your overall participation on the study will be over after 5 years.

      Treatment Planning and Schedule:

      You will receive a standard CT simulation which will cover your head and neck for treatment
      planning. You will also have a PET-CT to check the status of the disease and for treatment
      planning purposes.

      If you are among the first 15 participants or are in Group 1, you also will have an MRI
      simulation for treatment planning purposes.

      All groups will then receive radiation therapy 1 time each day, 5 days a week (Monday through
      Friday) for up to 33 treatments (about 6 ½ weeks).

      Study Visits:

      Every week while you are receiving radiation therapy:

        -  You will have a physical exam.

        -  Blood (about 1-2 tablespoons) will be drawn for routine tests.

        -  You will fill out the same questionnaires as before.

        -  You will have an MRI.

      At Weeks 3 and 6:

        -  Photos of the inside of your mouth will be taken to check for mouth sores.

        -  You will have a dental exam.

      If you are among the first 15 participants or are in Group 1, you will also have the MRI
      simulation at the end of Weeks 1, 2, 3, and 4 of treatment.

      Six (6) weeks after finishing radiation therapy, you will complete the same questionnaires as
      before.

      Within 8-12 weeks after finishing radiation therapy:

        -  Photos of the inside of your mouth will be taken to check for mouth sores.

        -  You will have a hearing test.

        -  If you are among the first 15 participants or are in Group 1, you will have an MRI
           simulation.

      Six (6) months, 1 year, and 2 years after finishing radiation therapy:

        -  You will fill out the same questionnaires as before.

        -  You will have a mouth exam to check your swallowing function.

        -  Photos of the inside of your mouth will be taken to check for mouth sores.

        -  You will fill out the same questionnaires as before.

        -  You will have a video-strobe procedure to check your vocal cords.

        -  At 1 year only, you will have a dental exam and an MBS exam to test your swallowing
           function.

        -  At 1 year and 2 years only, you will also have a hearing test.

      Three to six (3-6) months, 1 year, and 18-24 months after finishing radiation therapy:

        -  You will have an MBS exam to test your swallowing function.

        -  You will fill out the same questionnaires as before.

        -  You will have the video-strobe procedure to check your vocal cords.

      Two (2) years after finishing radiation therapy and if the disease gets worse, blood (about 3
      teaspoons) will be drawn for circulating tumor cells (CTCs). This is a test of how many tumor
      cells are in the blood.

      Five (5) years after finishing radiation therapy, you will have an MBS exam to test your
      swallowing function and will complete the same questionnaires as before.

      If the doctor thinks it is needed during follow-up, you will have a tumor biopsy for tumor
      marker testing and a CT scan, MRI scan and/or PET/CT scan to check the status of the disease.

      Follow-Up Calls:

      During the 8-12 weeks while you are recovering from treatment, you will be called or emailed
      by an automated system every 2 weeks.

      This will be to remind you to fill out a web-based form that asks about any side effects you
      may have had. Completing the form should take about 10-15 minutes each time.
    

Trial Arms

NameTypeDescriptionInterventions
MRI Guided Intensity Modulated Radiotherapy (IMRT)ExperimentalModified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
    Standard-of-Care Intensity Modulated Radiotherapy (IMRT)Active ComparatorModified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

      Eligibility Criteria

              Inclusion Criteria:
      
                1. Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of
                   tongue, soft palate, or oropharyngeal walls). Clinical evidence should be documented,
                   and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient
                   to estimate the size of the primary for purposes of T staging.
      
                2. Age >/= 18 years
      
                3. Clinical stage T1-2, N0-1, or small volume N2b (AJCC, 7th ed.), with no distant
                   metastases, based on routine staging workup.
      
                4. Positive for HPV by p16 immunohistochemistry (IHC) or in situ hybridization (ISH)
      
                5. Lifetime pack-year history of <10 years, currently non-smoking for at least 5 years.
      
                6. No head and neck surgery of the primary tumor or lymph nodes except for incisional or
                   excisional biopsies.
      
                7. No lymph nodes larger than 3 cm in the greatest dimension
      
                8. No retropharyngeal nor level IV (or lower) lymphadenopathy (i.e. nodes in level I-III
                   only)
      
                9. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
      
               10. Dispositioned to single modality photon radiotherapy (i.e. no chemotherapy or previous
                   therapeutic intent surgery).
      
               11. For females of child-bearing age, a negative pregnancy test
      
              Exclusion Criteria:
      
                1. Previous radiation treatment for head and neck mucosal primary cancers within the past
                   5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
      
                2. Pregnant or breast-feeding females
      
                3. Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic,
                   gastrointestinal or hematologic disease but not limited to: *Symptomatic congestive
                   heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
      
                4. Myocardial infarction within 3 months of registration
      
                5. Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators,
                   stimulators, pacemakers, or neurotransmitters) per institutional policy on management
                   of patients with internal and external medical devices.
      
                6. History of claustrophobia
      
                7. Having an estimated glomerular filtration rate (GFR) < 40ml/min/1.73m^2
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Locoregional Control
      Time Frame:6 months post radiation therapy
      Safety Issue:
      Description:Relapse defined as reappearance of tumor after complete response. If possible, relapse confirmed by biopsy.

      Secondary Outcome Measures

      Measure:Overall Survival
      Time Frame:Start of treatment up to 5 years
      Safety Issue:
      Description:Overall survival, calculated as time from diagnosis to either death or last follow-up, with death serving as an event and all others censored.
      Measure:Progression-Free Survival
      Time Frame:Start of treatment up to 5 years
      Safety Issue:
      Description:Progression-free survival, calculated as time from diagnosis to either death or detection of recurrent disease after an interval without radiographic of clinically evident disease (whichever is earlier), with death or recurrence detection serving as an event and all others censored.
      Measure:Distant Metastasis-Free Survival
      Time Frame:Start of treatment up to 5 years
      Safety Issue:
      Description:Distant metastasis-free survival, calculated as time from diagnosis to either death or detection of disease outside of the head and neck after an interval without radiographic of clinically evident disease (whichever is earlier), with death or metastasis detection serving as an event and all others censored.
      Measure:Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Symptom Inventory (MDASI)
      Time Frame:Baseline up to 2 years after radiation therapy
      Safety Issue:
      Description:Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI)
      Measure:Physician-Reported Toxicity
      Time Frame:Weekly during radiation therapy up to 2 years after radiation therapy
      Safety Issue:
      Description:Physician-reported toxicity, defined as any grade 3-4 adverse events using Common Terminology Criteria for Adverse Events (CTCAE)-4.0.
      Measure:Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Dysphagia Inventory (MDADI)
      Time Frame:Baseline up to 2 years after radiation therapy
      Safety Issue:
      Description:
      Measure:Patient Reported Outcome (PRO) Measures of Symptoms Using FACT-HN
      Time Frame:Baseline up to 2 years after radiation therapy
      Safety Issue:
      Description:
      Measure:Patient Reported Outcome (PRO) Measures of Symptoms Using Xerostomia and Health Questionnaire (EQ-5D-3L)
      Time Frame:Baseline up to 2 years after radiation therapy
      Safety Issue:
      Description:
      Measure:Patient Reported Outcome (PRO) Measures of symptoms Using Performance Status Scale-HN
      Time Frame:Baseline up to 2 years after radiation therapy
      Safety Issue:
      Description:
      Measure:Patient Reported Outcome (PRO) Measures of symptoms Using Work Productivity and Activity Impairment Questionnaire
      Time Frame:Baseline up to 2 years after radiation therapy
      Safety Issue:
      Description:

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:M.D. Anderson Cancer Center

      Trial Keywords

      • Malignant neoplasms of lip oral cavity and pharynx
      • Oropharyngeal Cancer
      • Human papilloma virus positive
      • HPV+
      • Squamous cell carcinoma of the oropharynx
      • Squamous cell carcinoma of the tonsil
      • Squamous cell carcinoma of the base of tongue
      • Squamous cell carcinoma of the soft palate
      • Squamous cell carcinoma of the oropharyngeal walls
      • Magnetic Resonance Imaging Guided Radiotherapy
      • Standard of Care Radiotherapy Planning
      • Radiation Therapy
      • Intensity modulated radiotherapy
      • IMRT
      • Modified Barium Swallow
      • MBS
      • Swallowing questionnaire
      • The M.D. Anderson Dysphagia Inventory (MDADI)
      • Symptom questionnaire
      • The M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
      • Video-Strobe Procedure

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