Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03224000
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Clifton Fuller, MD, PHD
Phone 713-563-2300
Email cdfuller@mdanderson.org
Status Recruiting
Phase Phase 2
Start date January 17, 2018
Completion date December 30, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03656133 - Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers N/A
Terminated NCT02225496 - Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma Phase 2
Withdrawn NCT01767961 - Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer N/A
Completed NCT01695122 - Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT01435252 - A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab Phase 2
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Withdrawn NCT00951470 - Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema N/A
Completed NCT01358097 - Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy N/A
Completed NCT01342978 - Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time N/A
Completed NCT00964977 - Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. Phase 3
Recruiting NCT05363709 - BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients Phase 2
Completed NCT02280811 - T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers Phase 2
Active, not recruiting NCT03777384 - EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
Active, not recruiting NCT03729518 - TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck N/A
Recruiting NCT06121102 - Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain N/A
Recruiting NCT02984410 - Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma N/A
Recruiting NCT02960724 - uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer Phase 2
Completed NCT02934724 - Impact of HPV Vaccine On The Prevalence Of HPV In Norway
Withdrawn NCT00928161 - Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy N/A
Recruiting NCT02012699 - Integrated Cancer Repository for Cancer Research