Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck

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ClinicalTrials.gov Identifier: NCT01893307

Recruitment Status : Recruiting

First Posted : July 9, 2013

Last Update Posted : May 23, 2019

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Sponsor:

Collaborators:

National Cancer Institute (NCI)

National Institute of Dental and Craniofacial Research (NIDCR)

Massachusetts General Hospital

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Head And Neck Cancer	Radiation: Intensity-Modulated X-Ray Therapy (IMRT) Radiation: Intensity-Modulated Proton Beam Therapy (IMPT) Procedure: Modified barium swallow (MBS) Behavioral: Questionnaires	Phase 2 Phase 3

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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 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 have a video-strobe procedure or laryngoscopy 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. A laryngoscopy is a standard procedure in which a tube with a lighted camera is inserted through your mouth and into your 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. An email address will be collected for the transmitting questionnaires. An email address will be collected for the transmitting questionnaires.
Saliva will be collected and your jaw will be measured 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.

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 ½ 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.

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.
Blood (about 1-2 tablespoons) will be drawn for routine tests.
You will fill out the same questionnaires as before.
At Week 3, 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 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.

End-of-Treatment Visit:

After you finish radiation therapy (at Week 7):

You will fill out the same questionnaires as before.
You will have a dental exam, including jaw measurements and collection of saliva.
Photos of the inside of your mouth will be taken to check for mouth sores.

Follow-Up:

At 8-12 weeks after finishing radiation therapy:

You will have a dental exam, including jaw measurements and collection of 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 or PET/CT scan to check the status of the disease.

During Follow-Up Months 6, 12, and 24:

You will have an MBS exam to test your swallowing function.
You will fill out the same questionnaires as before.
Saliva and jaw measurements will be collected.
Photos of the inside of your mouth will be taken to check for mouth sores.
You will have a laryngoscopy or video-strobe procedure to allow the doctor to look at your vocal cords.
You will have a CT or PET scan.

During Follow-Up Months 9, 16, and 20:

Saliva and jaw measurements will be collected.
You will fill out the same questionnaires as before.
You will have a CT or PET scan.

Every 6 months during Follow-Up Month 30 through Follow-Up Year 5:

You will fill out the same questionnaires as before.
You will have a CT or PET scan.

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	360 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II/III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck
Actual Study Start Date :	August 2013
Estimated Primary Completion Date :	August 2023
Estimated Study Completion Date :	August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head and Neck Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intensity-Modulated X-Ray Therapy (IMRT) Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks). Treating physician evaluate each patient for possible chemotherapy. Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy. Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.	Radiation: Intensity-Modulated X-Ray Therapy (IMRT) Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks). Treating physician evaluate each patient for possible chemotherapy. Procedure: Modified barium swallow (MBS) Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy. Behavioral: Questionnaires Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy. Other Name: Surveys
Experimental: Intensity-Modulated Proton Beam Therapy (IMPT) Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks). Treating physician evaluate each patient for possible chemotherapy. Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy. Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.	Radiation: Intensity-Modulated Proton Beam Therapy (IMPT) Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks). Treating physician evaluate each patient for possible chemotherapy. Procedure: Modified barium swallow (MBS) Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy. Behavioral: Questionnaires Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy. Other Name: Surveys

Arm

Intervention/treatment

Experimental: Intensity-Modulated X-Ray Therapy (IMRT)

Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks).

Treating physician evaluate each patient for possible chemotherapy.

Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy.

Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.

Radiation: Intensity-Modulated X-Ray Therapy (IMRT)

Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks).

Treating physician evaluate each patient for possible chemotherapy.

Procedure: Modified barium swallow (MBS)

Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy.

Behavioral: Questionnaires

Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.

Other Name: Surveys

Experimental: Intensity-Modulated Proton Beam Therapy (IMPT)

Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks).

Treating physician evaluate each patient for possible chemotherapy.

Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy.

Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.

Radiation: Intensity-Modulated Proton Beam Therapy (IMPT)

Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks).

Treating physician evaluate each patient for possible chemotherapy.

Procedure: Modified barium swallow (MBS)

Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy.

Behavioral: Questionnaires

Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.

Other Name: Surveys

Outcome Measures

Primary Outcome Measures :

Rates and Severity of Late Grade 3-5 Toxicity Between Intensity-Modulated X-Ray Therapy (IMRT) and Intensity-Modulated Proton Beam Therapy (IMPT) [ Time Frame: 90 days to 2 years post radiation therapy ]
Cumulative incidence of late onset grade 3+ toxicity anytime during the 2 years following completion of radiation therapy where late onset toxicity occurs 90 days or more following completion of radiation therapy and is graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Secondary Outcome Measures :

Progression-Free Survival (PFS) Between Concurrent Chemo-Radiation Strategies with IMRT and IMPT Following the Treatment of Oropharyngeal Tumors [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >/= 18
Histologically documented Squamous Cell Carcinoma of the oropharynx (American Joint Committee on Cancer (AJCC) v7** Stage III-IV A,B)
Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or p16 (in situ hybridization (ISH), immunohistochemistry (IHC) or genotyping testing) If you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing.
Eastern Cooperative Oncology Group (ECOG) performance status= 0, 1, or 2
Negative pregnancy test for women of child bearing potential
Concurrent Chemotherapy
Bilateral Neck Radiation

Exclusion Criteria:

Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
Pregnant or breast-feeding females
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) Myocardial infarction within 3 months of registration.
Distant Metastases (Stage IV C, any T, any N and M1)
Previous surgical resection or neck dissection for oropharyngeal cancer, administered with therapeutic intent.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893307

Contacts

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Contact: Steven J. Frank, MD	713-563-2300	sjfrank@mdanderson.org

Locations

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United States, Arizona
Mayo Clinic - Arizona	Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
University of California at San Diego	Recruiting
La Jolla, California, United States, 92093
Contact: Loren Mell, MD
United States, Florida
UF Health Proton Therapy Institute	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Roi Dagan, MD
Contact: Jin Park, BSH (877) 686-6009 jinpark@floridaproton.org
United States, Illinois
Northwestern Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60611
Contact: John H. Han-Chang, MD
United States, Maryland
University of Maryland	Recruiting
College Park, Maryland, United States, 20742
Contact: William Regine, MD
Contact: Charles Simone, MD
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Paul Busse, MD
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert Foote, MD
United States, New York
Memorial-Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Nancy Y. Lee, MD
United States, Pennsylvania
University of Pennsylvania Health System	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alexander Lin, MD
United States, Texas
University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98105
Contact: Upendra Parvathaneni, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

National Institute of Dental and Craniofacial Research (NIDCR)

Massachusetts General Hospital

Investigators

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Principal Investigator:	Steven J. Frank, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gunn GB, Blanchard P, Garden AS, Zhu XR, Fuller CD, Mohamed AS, Morrison WH, Phan J, Beadle BM, Skinner HD, Sturgis EM, Kies MS, Hutcheson KA, Rosenthal DI, Mohan R, Gillin MT, Frank SJ. Clinical Outcomes and Patterns of Disease Recurrence After Intensity Modulated Proton Therapy for Oropharyngeal Squamous Carcinoma. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):360-367. doi: 10.1016/j.ijrobp.2016.02.021. Epub 2016 Feb 12.

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Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01893307
Other Study ID Numbers:	2012-0825 NCI-2013-01879 ( Registry Identifier: NCI CTRP ) R03CA188162 ( U.S. NIH Grant/Contract ) 2U19CA021239 ( U.S. NIH Grant/Contract )
First Posted:	July 9, 2013 Key Record Dates
Last Update Posted:	May 23, 2019
Last Verified:	May 2019

Keywords provided by M.D. Anderson Cancer Center:


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

Additional relevant MeSH terms:

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Head and Neck Neoplasms Oropharyngeal Neoplasms Neoplasms by Site Neoplasms Pharyngeal Neoplasms	Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases

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