Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT)
Conditions
Head And Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head And Neck Cancer, Oropharyngeal Cancer, Squamous cell carcinoma of the oropharynx, Acute and late toxicity, Intensity modulated photon therapy, IMRT, Intensity modulated proton therapy, IMPT, Modified barium swallow, MBS, Questionnaires, Surveys
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Intensity-Modulated X-Ray Therapy (IMRT) Type: Radiation
Name: Intensity-Modulated Proton Beam Therapy (IMPT) Type: Radiation
Name: Modified barium swallow (MBS) Type: Procedure
Name: Questionnaires Type: Behavioral
Overall Status
Recruiting
Summary
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 may 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.
Detailed Description
Baseline Visit:

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 be asked about your diet and if you have had recent weight loss.

- You will have a hearing test.

- You will have a dental exam.

- 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. As part of this exam, each time you will fill out a questionnaire about swallowing that should take about 5 minutes to complete. You will be asked to sign a separate consent form that describes the MBS procedure and its risks.

- You will have a video-strobe procedure to allow the doctor to look at 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.

- Saliva will be collected at this visit, at the end of your treatment, and also during follow up for 2 years. You should be fasting for a minimum of 60 minutes and instructions regarding the collection will be given.

Study Groups:

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.

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 ½ weeks).

You will receive chemotherapy while you are receiving radiation therapy. If this occurs, you will be asked to sign a separate 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.

Study Visits:

Every week while you are receiving radiation therapy:

- Any updates to your medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs and weight.

- Your performance status will be recorded.

- Blood (about 1-2 tablespoons) will be drawn for routine tests.

- You will fill out the same questionnaires as before.

- At Weeks 3 and 7, photos of the inside of your mouth will be taken to check for mouth sores.

Length of Treatment:

You may continue receiving radiation therapy for up to 6 ½ 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 the follow-up.

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.

End-of-Treatment Visit:

After you finish radiation therapy:

- You will fill out the same questionnaires as before.

- You will have a mouth exam to check your swallowing function.

- You will have a dental exam. During the exam, saliva will be collected to look at what is in your saliva.

- Photos of the inside of your mouth will be taken to check for mouth sores.

Follow-Up:

At 10-12 weeks after finishing radiation therapy:

- You will fill out the same questionnaires as before.

- You will have a hearing test.

- You will have a dental exam. During the exam, saliva will be collected to look at what is in your saliva.

- Photos of the inside of your mouth will be taken to check for mouth sores.

- If the doctor thinks it is needed, you will have a CT scan and/or PET/CT scan to check the status of the disease.

At the end of your radiation therapy and during every follow-up:

- You will have an MBS exam to test your swallowing function.

- You will fill out the same questionnaires as before.

- Saliva will be collected at each follow up visit for 2 years.

- Photos of the inside of your mouth will be taken to check for mouth sores during your follow up for 2 years.

- You will have a video-strobe procedure to allow the doctor to look at your vocal cords.

- You will have a hearing test at 12 and 24 months.

- If the doctor thinks it is needed, you will have a CT and/or PET scan at any of the follow-up visits.

After you finish radiation therapy and during the 8-12 weeks while you are recovering from treatment, you will be called or emailed by an automated system. This will be to remind you to fill out a web-based 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.

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. All will take part at MD Anderson.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Age >/= 18

2. Histologically documented squamous cell carcinoma of the oropharynx (Stage III-IV A,B)

3. Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) /p16 (in situ hybridization (ISH), immunohistochemistry (IHC) or genotyping testing)

4. Eastern Cooperative Oncology Group (ECOG) performance criteria = 0, 1, or 2

5. Negative pregnancy test for women of child bearing potential

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: a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device. b) No myocardial infarction within 3 months of registration.

4. Distant Metastases (Stage IV C, any T, any N and M1)

5. Previous TransOral Robotic Surgery (TORS) to the oropharynx
Location
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
August 2013
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page