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

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ClinicalTrials.gov Identifier: NCT03224000
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

July 14, 2017
July 21, 2017
January 23, 2018
January 17, 2018
January 2025   (Final data collection date for primary outcome measure)
  • Locoregional Control [ Time Frame: 6 months post radiation therapy ]
    Relapse defined as reappearance of tumor after complete response. If possible, relapse confirmed by biopsy.
  • Composite Dysphagia Outcome Determined by PEG Tube Dependence at Last Follow-Up [ Time Frame: 6 months post radiation therapy ]

    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.

    These include: 1) PEG tube dependence at last follow-up; 2) trace or frank aspiration seen on modified barium swallow study; 3) diagnosis of aspiration pneumonia; 4) presence of pharyngoesophageal structure on modified barium swallow study or endoscopy with subsequent need for dilation.

  • Composite Dysphagia Outcome Determined by Trace or Frank Aspiration Seen on Modified Barium Swallow Study [ Time Frame: 6 months post radiation therapy ]
    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
  • Composite Dysphagia Outcome Determined by Diagnosis of Aspiration Pneumonia [ Time Frame: 6 months post radiation therapy ]
    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
  • Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Modified Barium Swallow Study [ Time Frame: 6 months post radiation therapy ]
    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
  • Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Endoscopy with Subsequent Need for Dilation [ Time Frame: 6 months post radiation therapy ]
    Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
Same as current
Complete list of historical versions of study NCT03224000 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Start of treatment up to 5 years ]
    Overall survival, calculated as time from diagnosis to either death or last follow-up, with death serving as an event and all others censored.
  • Progression-Free Survival [ Time Frame: Start of treatment up to 5 years ]
    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.
  • Distant Metastasis-Free Survival [ Time Frame: Start of treatment up to 5 years ]
    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.
  • Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Symptom Inventory (MDASI) [ Time Frame: Baseline up to 2 years after radiation therapy ]
    Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI)
  • Physician-Reported Toxicity [ Time Frame: Weekly during radiation therapy up to 2 years after radiation therapy ]
    Physician-reported toxicity, defined as any grade 3-4 adverse events using Common Terminology Criteria for Adverse Events (CTCAE)-4.0.
  • Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Dysphagia Inventory (MDADI) [ Time Frame: Baseline up to 2 years after radiation therapy ]
  • Patient Reported Outcome (PRO) Measures of Symptoms Using FACT-HN [ Time Frame: Baseline up to 2 years after radiation therapy ]
  • 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 ]
  • Patient Reported Outcome (PRO) Measures of symptoms Using Performance Status Scale-HN [ Time Frame: Baseline up to 2 years after radiation therapy ]
  • Patient Reported Outcome (PRO) Measures of symptoms Using Work Productivity and Activity Impairment Questionnaire [ Time Frame: Baseline up to 2 years after radiation therapy ]
Same as current
Not Provided
Not Provided
 
Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
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.

Baseline Visit:

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

  • Participant will have a hearing test.
  • Participant will have a dental exam. During this exam, participant's saliva flow will be measured and participant will be checked for lockjaw.
  • Participant's swallowing function will be tested with a special type of x-ray called a modified barium swallow (MBS). During the test, participant will eat and drink foods and liquids mixed with a "contrast" chemical called barium that will make participant's 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 participant's mouth and down participant's throat.
  • Participant will complete a questionnaire about swallowing that should take about 5 minutes to complete.
  • Participant will have a video-strobe procedure to check participant's vocal cords. To perform a video-strobe procedure, a small camera will be inserted into the throat through participant's nose or mouth. Participant will be awake for this procedure and the study staff will give participant the option of receiving a numbing spray for participant's nose and/or throat.
  • Photos of the inside of participant's mouth will be taken to check for mouth sores.
  • Participant will fill out questionnaires about participant's quality of life, work status, medical history, smoking status, and any symptoms participant may have. Completing these questionnaires should take about 10-15 minutes.

Study Groups:

If participant is among the first 15 patients enrolled in the study, participant will be in Group 1.

If participant joins the study after the first 15 patients have enrolled, participant 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 participant is in Group 1, an MRI will be used to plan participant's IMRT.
  • If participant is in Group 2, participant will receive standard-of-care IMRT.

Length of Study Participation:

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

Participant's overall participation on the study will be over after 5 years.

Treatment Planning and Schedule:

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

If participant is among the first 15 participants or is in Group 1, participant 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 participant is receiving radiation therapy:

  • Participant will have a physical exam.
  • Blood (about 1-2 tablespoons) will be drawn for routine tests.
  • Participant will fill out the same questionnaires as before.
  • Participant will have an MRI.

At Weeks 3 and 6:

  • Photos of the inside of participant's mouth will be taken to check for mouth sores.
  • Participant will have a dental exam.

At Week 3 only, participant will have the video-strobe procedure to check participant's vocal cords.

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

Within 8-12 weeks after finishing radiation therapy:

  • Photos of the inside of participant's mouth will be taken to check for mouth sores.
  • Participant will have a hearing test.
  • If participant is among the first 15 participants or is in Group 1, participant will have an MRI simulation.

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

  • Participant will fill out the same questionnaires as before.
  • Participant will have a mouth exam to check participant's swallowing function.
  • Photos of the inside of participant's mouth will be taken to check for mouth sores.
  • Participant will fill out the same questionnaires as before.
  • Participant will have a video-strobe procedure to check participant's vocal cords.

Six (6) months, 2 years, and 5 years after finishing radiation therapy, participant will have an MBS exam to test participant's swallowing function.

One (1) year after finishing radiation therapy, participant will have a dental exam.

One (1) year and 2 years after finishing radiation therapy, participant will have a hearing test.

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.

If the doctor thinks it is needed during follow-up, participant 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 participant is recovering from treatment, participant will be called or emailed by an automated system every 2 weeks.

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

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Malignant Neoplasms of Lip Oral Cavity and Pharynx
  • Oropharyngeal Cancer
  • Procedure: Modified Barium Swallow (MBS)
    Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
  • Behavioral: Swallowing Questionnaire
    Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
    Other Name: The M.D. Anderson Dysphagia Inventory (MDADI)
  • Behavioral: Symptom Questionnaire
    Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
    Other Name: The M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
  • Procedure: Video-Strobe Procedure
    Video-strobe procedure to check vocal cords performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
  • Procedure: MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning
    IMRT planned with MRI guidance.
  • Procedure: Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning
    IMRT planned by standard-of-care.
  • Radiation: Intensity Modulated Radiotherapy (IMRT)
    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.
    Other Names:
    • Radiation therapy
    • XRT
  • Experimental: MRI Guided Intensity Modulated Radiotherapy (IMRT)

    Modified 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.

    Interventions:
    • Procedure: Modified Barium Swallow (MBS)
    • Behavioral: Swallowing Questionnaire
    • Behavioral: Symptom Questionnaire
    • Procedure: Video-Strobe Procedure
    • Procedure: MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning
    • Radiation: Intensity Modulated Radiotherapy (IMRT)
  • Active Comparator: Standard-of-Care Intensity Modulated Radiotherapy (IMRT)

    Modified 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.

    Interventions:
    • Procedure: Modified Barium Swallow (MBS)
    • Behavioral: Swallowing Questionnaire
    • Behavioral: Symptom Questionnaire
    • Procedure: Video-Strobe Procedure
    • Procedure: Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning
    • Radiation: Intensity Modulated Radiotherapy (IMRT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Same as current
January 2026
January 2025   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Clifton Fuller, MD, PHD 713-563-2300 CR_Study_Registration@mdanderson.org
United States
 
 
NCT03224000
2015-0851
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Clifton Fuller, MD, PHD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP