The goal of this clinical research study is to compare the side effects of 2 radiation treatments for head and neck cancer. The 2 treatments are intensity modulated photon therapy (IMRT) and intensity modulated proton therapy (IMPT). Participants will also receive chemotherapy along with radiation therapy.
IMPT is designed to use beams of proton particles to send radiation to the tumor. IMRT is designed to use beams of photon therapy to send radiation to the tumor. Both of these types of radiation treatment may give a full dose of radiation treatment to the tumor while not damaging as much of the healthy tissue around it.
This is an investigational study. IMRT and IMPT are delivered using FDA-approved and commercially available methods. Comparing them is investigational.
Up to 360 participants will be enrolled in this study. Up to 250 patients will take part at MD Anderson.
If you are found to be eligible to take part in this study, you will have a baseline visit. The following tests and procedures will be performed:
You will go through the standard radiation treatment planning procedure, called the marking session. After the marking session, a standard IMRT plan and an IMPT plan will be made. If the radiation doctor thinks that both the plans are acceptable, you will be randomly assigned (as a flip of a coin) to 1 of 2 study groups:
If you are in Group 1, you will receive IMRT.
If you are in Group 2, you will receive IMPT.
If you are assigned to Group 1 but do not receive the IMRT treatment, you will be moved to Group 4. You will then have follow-up only to be asked about the status of the disease and how you are doing, as explained below.
If you are assigned to Group 2 but do not receive the IMPT treatment, you will be moved to Group 3. You will then have follow-up only to be asked about the status of the disease and how you are doing.
Study Therapy Administration:
You will receive radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 weeks).
You will receive chemotherapy while you are receiving radiation therapy. You will be asked to sign a separate treatment consent form for these drugs with a full description of how they are given and the risks they may cause. The drugs, schedule, and doses will be your doctor's decision.
Every week while you are receiving radiation therapy:
Length of Treatment:
You may continue receiving radiation therapy for up to 6 weeks. You will no longer be able to receive the study therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after you complete all the follow-up visits.
You can decide to stop taking part in this study and the study doctor will tell you how to stop safely. It is important to tell the study doctor if you are thinking about stopping so any side effects from the treatment can be looked at by your doctor. Another reason to tell your doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you.
After you finish radiation therapy (at Week 7):
At 8-12 weeks after finishing radiation therapy:
During Follow-Up Months 6, 12, and 24:
During Follow-Up Months 9, 16, and 20:
Every 6 months during Follow-Up Month 30 through Follow-Up Year 5:
After you finish radiation therapy and during the 8-12 weeks while you are recovering from treatment, you will be provided with a questionnaire, by email or in paper form, that asks about any side effects you may have had. You will fill out this form every 2 weeks during this time period. Filling out the form should take about 10-15 minutes.
Filling out these forms does not take the place of your regularly scheduled follow-up visits. If you have side effects, you should also tell the study staff.
If the doctor thinks it is needed during follow-up, you will have a tumor biopsy for tumor marker testing.
|Treatment||Questionnaires, Intensity-Modulated X-Ray Therapy (IMRT), Intensity-Modulated Proton Beam Therapy (IMPT), Modified barium swallow (MBS)|
|Clinical Study Identifier||NCT01893307|
|Sponsor||M.D. Anderson Cancer Center|
|Last Modified on||8 October 2020|
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.Learn more
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.Learn more
Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.Learn more
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