Malignant Neoplasms of Lip Oral Cavity and PharynxPhase 2NCT03224000
Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
A Phase 2 study testing Modified Barium Swallow (MBS), Swallowing Questionnaire and Symptom Questionnaire in people with Malignant Neoplasms of Lip Oral Cavity and Pharynx and Oropharyngeal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Lip Oral Cavity and Pharynx, Oropharyngeal Cancer
- What is being tested?
- Modified Barium Swallow (MBS), Swallowing Questionnaire and Symptom Questionnaire
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2018to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age ≥18 years
- Clinical stage T1-3, N0-2 (AJCC, 8th ed.), with no distant metastases, based on routine staging workup.
- Positive for HPV by p16 IHC or ISH
- Lifetime pack-year history of <10 years, currently non-smoking for at least 5 years.
- No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
Show all 10Show fewer
- No retropharyngeal nor level IV (or lower) lymphadenopathy (i.e. nodes in level I-III only)
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
- Dispositioned to photon/proton radiotherapy +/- chemotherapy
- For females of child-bearing age, a negative pregnancy test
Who cannot join
- Patients who have undergone definitive resection of their primary or nodal disease as well as any chemotherapy or radiation therapy for their HNSCC.
- Pregnant or breast-feeding females
- 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
- Myocardial infarction within 3 months of registration
- 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.
- History of claustrophobia
- Having an estimated glomerular filtration rate (GFR) < 40ml/min/1.73m2
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
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 90 participants will be enrolled in this study. All will take part at MD Anderson.
Read the 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.
- Being tested
- Modified Barium Swallow (MBS), Swallowing Questionnaire, Symptom Questionnaire, Video-Strobe Procedure, MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning
- 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)
- Medical subject headings
- Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Barium Swallow (MBS)Procedure or surgery
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing QuestionnaireBehavioural
Also called The M.D. Anderson Dysphagia Inventory (MDADI)
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 QuestionnaireBehavioural
Also called The M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
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 ProcedureProcedure or surgery
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.
MRI Guided Intensity Modulated Radiotherapy (IMRT) PlanningProcedure or surgery
IMRT planned with MRI guidance.
Standard-of-Care Intensity Modulated Radiotherapy (IMRT) PlanningProcedure or surgery
IMRT planned by standard-of-care.
Intensity Modulated Radiotherapy (IMRT)Radiation
Also called Radiation therapy, XRT
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.
| Study group | Role | What they receive |
|---|---|---|
| MRI Guided Intensity Modulated Radiotherapy (IMRT) | Experimental | 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. Receives: 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) |
| Standard-of-Care Intensity Modulated Radiotherapy (IMRT) | Active comparator | 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Control
Relapse defined as reappearance of tumor after complete response. If possible, relapse confirmed by biopsy.
Measured: 6 months post radiation therapy
Composite Dysphagia Outcome Determined by PEG Tube Dependence at Last Follow-Up
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.
Measured: 6 months post radiation therapy
Composite Dysphagia Outcome Determined by Trace or Frank Aspiration Seen on Modified Barium Swallow Study
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
Measured: 6 months post radiation therapy
Composite Dysphagia Outcome Determined by Diagnosis of Aspiration Pneumonia
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
Measured: 6 months post radiation therapy
Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Modified Barium Swallow Study
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
Measured: 6 months post radiation therapy
Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Endoscopy with Subsequent Need for Dilation
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
Measured: 6 months post radiation therapy
Secondary outcomes (10)
Overall Survival
Overall survival, calculated as time from diagnosis to either death or last follow-up, with death serving as an event and all others censored.
Measured: Start of treatment up to 5 years
Progression-Free Survival
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.
Measured: Start of treatment up to 5 years
Distant Metastasis-Free Survival
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.
Measured: Start of treatment up to 5 years
Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Symptom Inventory (MDASI)
Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI)
Measured: Baseline up to 2 years after radiation therapy
Physician-Reported Toxicity
Physician-reported toxicity, defined as any grade 3-4 adverse events using Common Terminology Criteria for Adverse Events (CTCAE)-4.0.
Measured: Weekly during radiation therapy up to 2 years after radiation therapy
Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Dysphagia Inventory (MDADI)
Measured: Baseline up to 2 years after radiation therapy
Patient Reported Outcome (PRO) Measures of Symptoms Using FACT-HN
Measured: Baseline up to 2 years after radiation therapy
Patient Reported Outcome (PRO) Measures of Symptoms Using Xerostomia and Health Questionnaire (EQ-5D-3L)
Measured: Baseline up to 2 years after radiation therapy
Patient Reported Outcome (PRO) Measures of symptoms Using Performance Status Scale-HN
Measured: Baseline up to 2 years after radiation therapy
Patient Reported Outcome (PRO) Measures of symptoms Using Work Productivity and Activity Impairment Questionnaire
Measured: Baseline up to 2 years after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start17 Jan 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasms of Lip Oral Cavity and PharynxStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clifton Fuller, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224000
- Sponsor's protocol ID
- 2015-0851
- Other IDs
- NCI-2018-01109
- Status last verified
- Jun 2026
- First submitted
- 14 Jul 2017
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bahig H, Yuan Y, Mohamed ASR, Brock KK, Ng SP, Wang J, Ding Y, Hutcheson K, McCulloch M, Balter PA, Lai SY, Al-Mamgani A, Sonke JJ, van der Heide UA, Nutting C, Li XA, Robbins J, Awan M, Karam I, Newbold K, Harrington K, Oelfke U, Bhide S, Philippens MEP, Terhaard CHJ, McPartlin AJ, Blanchard P, Garden AS, Rosenthal DI, Gunn GB, Phan J, Cazoulat G, Aristophanous M, McSpadden KK, Garcia JA, van den Berg CAT, Raaijmakers CPJ, Kerkmeijer L, Doornaert P, Blinde S, Frank SJ, Fuller CD. Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL stage 2a-2b/Bayesian phase II trial. Clin Transl Radiat Oncol. 2018 Aug 24;13:19-23. doi: 10.1016/j.ctro.2018.08.003. eCollection 2018 Nov.
PubMed 30386824
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT03224000
- Acronym / sponsor ID
- 2015-0851
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 90 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI Guided Intensity Modulated Radiotherapy (IMRT) | Experimental | 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)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. |
| Standard-of-Care Intensity Modulated Radiotherapy (IMRT) | Active comparator | 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)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Age ≥18 years
- Clinical stage T1-3, N0-2 (AJCC, 8th ed.), with no distant metastases, based on routine staging workup.
- Positive for HPV by p16 IHC or ISH
- Lifetime pack-year history of <10 years, currently non-smoking for at least 5 years.
Key exclusion criteria (8 listed)
- Patients who have undergone definitive resection of their primary or nodal disease as well as any chemotherapy or radiation therapy for their HNSCC.
- Pregnant or breast-feeding females
- 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
- Myocardial infarction within 3 months of registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Barium Swallow (MBS)Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. | Procedure or surgery | MRI Guided Intensity Modulated Radiotherapy (IMRT), Standard-of-Care Intensity Modulated Radiotherapy (IMRT) |
| Swallowing QuestionnaireAlso: The M.D. Anderson Dysphagia Inventory (MDADI)Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. | Behavioural | MRI Guided Intensity Modulated Radiotherapy (IMRT), Standard-of-Care Intensity Modulated Radiotherapy (IMRT) |
| Symptom QuestionnaireAlso: The M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. | Behavioural | MRI Guided Intensity Modulated Radiotherapy (IMRT), Standard-of-Care Intensity Modulated Radiotherapy (IMRT) |
| Video-Strobe ProcedureVideo-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 or surgery | MRI Guided Intensity Modulated Radiotherapy (IMRT), Standard-of-Care Intensity Modulated Radiotherapy (IMRT) |
| MRI Guided Intensity Modulated Radiotherapy (IMRT) PlanningIMRT planned with MRI guidance. | Procedure or surgery | MRI Guided Intensity Modulated Radiotherapy (IMRT) |
| Standard-of-Care Intensity Modulated Radiotherapy (IMRT) PlanningIMRT planned by standard-of-care. | Procedure or surgery | Standard-of-Care Intensity Modulated Radiotherapy (IMRT) |
| Intensity Modulated Radiotherapy (IMRT)Also: Radiation therapy, XRTParticipants 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. | Radiation | MRI Guided Intensity Modulated Radiotherapy (IMRT), Standard-of-Care Intensity Modulated Radiotherapy (IMRT) |
Primary outcome
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.
10 secondary outcomes
Overall Survival
Time frame: Start of treatment up to 5 years
Progression-Free Survival
Time frame: Start of treatment up to 5 years
Distant Metastasis-Free Survival
Time frame: Start of treatment up to 5 years
Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Symptom Inventory (MDASI)
Time frame: Baseline up to 2 years after radiation therapy
Physician-Reported Toxicity
Time frame: Weekly during radiation therapy up to 2 years after radiation therapy
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Derived from this study: PubMed 30386824Bahig H, Yuan Y, Mohamed ASR, Brock KK, Ng SP, Wang J, Ding Y, Hutcheson K, McCulloch M, Balter PA, Lai SY, Al-Mamgani A, Sonke JJ, van der Heide UA, Nutting C, Li XA, Robbins J, Awan M, Karam I, Newbold K, Harrington K, Oelfke U, Bhide S, Philippens MEP, Terhaard CHJ, McPartlin AJ, Blanchard P, Garden AS, Rosenthal DI, Gunn GB, Phan J, Cazoulat G, Aristophanous M, McSpadden KK, Garcia JA, van den Berg CAT, Raaijmakers CPJ, Kerkmeijer L, Doornaert P, Blinde S, Frank SJ, Fuller CD. Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL stage 2a-2b/Bayesian phase II trial. Clin Transl Radiat Oncol. 2018 Aug 24;13:19-23. doi: 10.1016/j.ctro.2018.08.003. eCollection 2018 Nov.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifton Fuller, MD, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modified Barium Swallow (MBS), Swallowing Questionnaire and Symptom Questionnaire in people with Malignant Neoplasms of Lip Oral Cavity and Pharynx and Oropharyngeal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional Control (time frame: 6 months post radiation therapy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.