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Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
Study 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 90 participants will be enrolled in this study. All will take part at MD Anderson.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
- - 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.- - Clinical stage T1-3, N0-2 (AJCC, 8th ed.
), with no distant metastases, based on routine staging workup.Exclusion Criteria:
- - History of claustrophobia.
- Having an estimated glomerular filtration rate (GFR) < 40ml/min/1.73m2Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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 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 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.- - 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 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 an MRI.
At Weeks 3 and 6:- - 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:- - If you are among the first 15 participants or are in Group 1, you will have an MRI
simulation.
Six- - 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 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.Arms
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.
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)
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.
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.
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Site Contact
[email protected]
713-563-2300
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