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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 : July 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Lip Oral Cavity and Pharynx Oropharyngeal Cancer Procedure: Modified Barium Swallow (MBS) Behavioral: Swallowing Questionnaire Behavioral: Symptom Questionnaire Procedure: Video-Strobe Procedure Procedure: MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning Procedure: Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning Radiation: Intensity Modulated Radiotherapy (IMRT) Phase 2

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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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
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.

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.

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

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.

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: 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




Primary Outcome Measures :
  1. Locoregional Control [ Time Frame: 6 months post radiation therapy ]
    Relapse defined as reappearance of tumor after complete response. If possible, relapse confirmed by biopsy.

  2. 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.


  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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.

  6. Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Dysphagia Inventory (MDADI) [ Time Frame: Baseline up to 2 years after radiation therapy ]
  7. Patient Reported Outcome (PRO) Measures of Symptoms Using FACT-HN [ Time Frame: Baseline up to 2 years after radiation therapy ]
  8. 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 ]
  9. Patient Reported Outcome (PRO) Measures of symptoms Using Performance Status Scale-HN [ Time Frame: Baseline up to 2 years after radiation therapy ]
  10. Patient Reported Outcome (PRO) Measures of symptoms Using Work Productivity and Activity Impairment Questionnaire [ Time Frame: Baseline up to 2 years after radiation therapy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224000


Contacts
Contact: Clifton Fuller, MD, PHD 713-563-2300 cdfuller@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       cdfuller@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Clifton Fuller, MD, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03224000     History of Changes
Other Study ID Numbers: 2015-0851
NCI-2018-01109 ( Registry Identifier: NCI CTRP )
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of lip oral cavity and pharynx
Oropharyngeal Cancer
The M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
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
Video-Strobe Procedure

Additional relevant MeSH terms:
Neoplasms
Oropharyngeal Neoplasms
Lip Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Neoplasms
Mouth Diseases
Papilloma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Lip Diseases