Clinical trial: NCT01302834
Section: Alternatives
Subsections: What Other Choices Do I Have If I Do Not Take Part In This Study? (10/17/13)

Your other choices may include:
Getting treatment or care for your cancer without being in a study Taking part in another study Getting no treatment You may choose not to be treated for cancer, but you may want to receive comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Clinical trial: NCT01302834
Section: Confidentiality
Subsections: Talk To Your Study Doctor About Your Choices Before You Decide If You Will Take Part In This Study. Will My Medical Information Be Kept Private? (6/3/14)

Data are housed at NRG Oncology in a password-protected database. We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.  
Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
NRG Oncology The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people The Cancer Trials Support Unit (CTSU), a service sponsored by the National Cancer Institute
(NCI) to provide greater access to cancer trials Qualified representatives of the pharmaceutical collaborator
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.  
The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. NRG Oncology will make no voluntary disclosures related to your participation in this research study. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, **as required by** U.S. law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at **any time.**
[Note to Informed Consent Authors: the above paragraph complies with the new FDA regulation found at 21 CFR 50.25(c) and must be included verbatim in all informed consent documents. The text in this paragraph cannot be revised.]
[Note to Local *Investigators: The NCI has recommended that HIPAA regulations be addressed by the* local institution. The regulations may or may not be included in the informed consent form depending on local institutional policy.]
Clinical trial: NCT01302834
Section: Duration of Study Involvement
Subsections: Before You Begin The Study:|During The Study:|Weekly During Treatment:|Study Plan How Long Will I Be In The Study?

You will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.  
Physical examination by several doctors Examination of the back of your throat and voice box (larynx) with a mirror and/or a flexible lighted tube inserted through your mouth by an ear, nose and throat specialist or by a head and neck surgeon; this examination may be done in an office or may need to be done in the hospital under general anesthesia. The specialist or surgeon will talk with you about this procedure.  
You will have the following:
a. A CT (Computed Tomography) scan of your neck (with contrast) and a chest CT scan
(with or without contrast) or b. An MRI (Magnetic Resonance Imaging) of your neck (with contrast) and a chest CT scan
(with or without contrast) or c. A CT scan of your neck (with contrast) and a PET/CT (Positron Emission Tomography)
scan of your neck and chest (with or without contrast) or d. An MRI of the neck (with contrast) and a PET/CT scan of your neck and chest (with or without contrast).  
- A CT scan is a study using x-rays to look at one part of your body. It may be done with or without contrast.  
- Contrast means that dye is injected into your vein to increase the differences between normal and abnormal tissue.  
- An MRI is imaging using a strong magnetic field to look at one part of your body. - A PET scan is a computerized image that looks at the activity of tumor cells in your entire body and that requires injection of a special marker into your vein, such as sugar (glucose) combined with a low-dose radioactive substance (a tracer). A
camera records the tracer's signal as it travels through your body.  
Evaluation of your ability to carry out daily activities Blood tests (about 3 teaspoons of blood will be taken from your vein)
For women able to have children, a pregnancy test A dental evaluation An evaluation of your ability to chew and swallow A hearing test You will be asked about your diet, eating, and speech.  
If your study doctor recommends:
Whole body PET/CT
An EKG, a test of your heart function An evaluation of your diet to see if a feeding tube is needed

If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will need the following tests and procedures. They are part of regular cancer care.

A physical examination Evaluation of your ability to carry out daily activities Blood tests (about 3 teaspoons of blood will be taken from your vein)
Evaluation of any side effects from treatment you may be having During treatment, if your study doctor recommends:
A whole body PET/CT
A CT scan, MRI, or PET/CT of your neck A biopsy to check for recurrence of the cancer Evaluation of any side effects from treatment more often than weekly, if needed

Group 1 patients will receive radiation therapy for about 6 weeks and cisplatin on days 1 and 22 during radiation.  
Group 2 patients will receive a dose of cetuximab a week before radiation therapy, and if they tolerate cetuximab well, will receive cetuximab once a week during the 6 weeks of radiation therapy and once after radiation therapy, for a total of 8 weeks of treatment. All patients will be asked to visit the office for follow up at 1 and 3 months from the end of treatment, then every 3 months through year 2, every 6 months for 3 years, then once a year for their lifetimes.
Clinical trial: NCT01302834
Section: Participant's Rights
Subsections: What Are My Rights If I Take Part In This Study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution.  
Page 11 We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.  
A Data Monitoring Committee (DMC) will be regularly meeting to monitor safety and other data related to this study. The Committee members may receive confidential patient information, but they will not receive your name or other information that would allow them to identify you by name.  
In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT01302834
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect From Being In The Study? (6/25/13)|Possible Side Effects Of Radiation To The Head And Neck|Possible Side Effects Related To Cisplatin (For Group 1 Patients) [Table Version Date: December 12, 2012]|Occasional, Some May Be Serious|Risks Associated With Cetuximab And Radiation Therapy|Reproductive Risks|What Happens If I Am Injured Because I Took Part In This Study?|Risks (6/25/13)

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, researchers don't know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects.  
Many side effects go away soon after you stop radiation therapy or stop taking cisplatin or cetuximab. In some cases, side effects can be serious, long lasting, or may never go away. There also is a risk of death.  
You should talk to your study doctor about any side effects that you have while taking part in the study.

| Possible Side Effects of Radiation to the Head and Neck COMMON, SOME MAY BE SERIOUS In 100 people receiving radiation therapy, more than 20 and up to 100 may have:  Sores in the mouth and/or throat which can be painful and make it very difficult to chew and  or swallow foods  Mouth dryness or changes in taste and/or smell that may be permanent  Thick saliva  Hoarseness  Tanning or redness and/or irritation of the skin in the head and neck area being treated with  radiation  Ear pain and/or pressure  Fatigue  Weight loss  Permanent hair loss in the area treated with radiation (face, chin, neck)  Loss of teeth, or cavities in the teeth, if strict dental care is not followed and/or  hypersensitivity of teeth   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
OCCASIONAL, SOME MAY BE SERIOUS  
In 100 people receiving radiation therapy, from 4 to 20 may have:  
Decrease in function of the thyroid gland that may require you to take thyroid replacement  
medicine to prevent you from feeling tired or sleepy  
Serious damage to the spinal cord, nerves in the neck, jawbone, voice box, skin, or other  
parts of the head and neck that may require a major operation to correct and, rarely, can  
even be life threatening  
Temporary pain or scarring around nerves in the shoulder that could cause numbness and/or  
weakness  
Breathing problems  
Difficulty with swallowing and eating for which you might need a long term or permanent  
feeding tube; possibility of inhaling food and/or liquids into the lungs - which could also result  
in pneumonia. This side effect is more likely for patients receiving radiation and cisplatin (Group 1).  
Serious ear infections and/or hearing loss  
Damage to the spinal cord leading to permanent weakness and/or symptoms like a "stroke"  
Loss of hearing  
Use of IGRT may lead to improved accuracy of radiation treatment compared to regular radiation therapy and eventually, that will be more useful against cancer. At this time, however, there is no proof that using this technique is more useful against cancer than regular radiation treatment without this technique. The dose from these x-ray images is much smaller than the dose used to treat your cancer. However, this dose will cover a somewhat larger region and can spill over to healthy tissues and organs that are not affected by your disease. There is a small risk that the dose from these x-ray images can be harmful, and every effort will be made to minimize this dose to healthy tissues. In this effort, it is important that we have your full cooperation in maintaining your position during treatment. In order to help you stay in position, your doctor will use a special device, sometimes called an immobilization mask. The mask is plastic mesh formed to the head and shoulder area to help stabilize your position during treatment

COMMON, SOME MAY BE SERIOUS
In 100 people receiving Cisplatin, more than 20 and up to 100 may have:
Nausea, vomiting Infection, especially when white blood cell count is low Anemia, which may cause tiredness, or may require blood transfusions Bruising, bleeding Kidney damage, which may cause swelling, may require dialysis Hearing decrease, including ringing in ears Change in taste
OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving Cisplatin, from 4 to 20 may have:
Allergic reaction, which may cause rash, low blood pressure, wheezing, shortness of breath, swelling of the face or throat Confusion Difficulty with balance Numbness in the fingers and toes Low blood pressure Low magnesium in the blood, which may cause heart beat irregularities that are possible life threatening RARE, AND SERIOUS
In 100 people receiving Cisplatin, 3 or fewer may have:
Cancer of bone marrow later in life caused by chemotherapy Seizure Possible Side Effects of Cetuximab (For Group 2 patients) **[Table Version Date: January 23, 2013]**  
COMMON, SOME MAY BE SERIOUS
In 100 people receiving Cetuximab, more than 20 and up to 100 may have:
Change in nails Swelling and redness of the area of radiation Rash, itching, dry skin, acne Dehydration, weight loss, loss of appetite Sores in mouth which may cause difficulty swallowing Constipation, diarrhea, vomiting, nausea Difficulty sleeping Headache, tiredness Pain Fever Infection, especially when white blood cell count is low Cough, shortness of breath

In 100 people receiving Cetuximab, from 4 to 20 may have:
Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath, swelling of the face or throat Confusion, depression, worry Fainting Severe blood infection Blood clot which may cause swelling, pain, shortness of breath RARE, AND SERIOUS
In 100 people receiving Cetuximab, 3 or fewer may have:
Scarring of the lungs Kidney damage which may require dialysis Heart stops beating Diphenhydramine (or other antihistamine) pre-medication used prior to cetuximab may impair your ability to drive home, and you may need to seek alternative transportation home. It may also impair your ability to safely use power equipment for several hours.

The combination of cetuximab with radiation therapy could increase the likelihood and/or severity of the side effects of radiation therapy. The combination also could increase the risk of heart damage, including heart attack, abnormal heart rhythms, and/or heart failure, which could lead to death.

You should not become pregnant or father a baby while on this study because the radiation treatment and/or cisplatin or cetuximab in this study can affect an unborn baby. Women who are able to have children will have a pregnancy test before beginning treatment. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study.  
Check with your study doctor about what kind of birth control methods to use and how long to use them.  
Some methods might not be approved for use in this study. The treatment in the study may make you unable to have children in the future. Women of childbearing age can ask their doctor for information about pre-treatment or post-treatment reproductive or fertility options prior to agreeing to participate in the study.  
For more information about risks and side effects, ask your study doctor.

It is important that you tell your study doctor, __________________ [investigator's *name(s)],* if you feel that you have been injured because of taking part in this study. You can tell the study doctor in person or call him/her at __________________ *[telephone number].*
You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment.

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small. Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included. The samples are given a code to protect your privacy before they are used. Any related information given to researchers will also be coded. Researchers will receive the code instead of any information that might directly identify you. There can be a risk in knowing genetic information. New health information about inherited traits that might affect you or your blood relatives could be found during a research study. Even though your genes are unique, you share some of the same genes with your blood relatives. Although we are not able to know all of the risks from taking part in research on inherited traits, we believe that the risks to you and your family are very low, because your samples will be coded. Research results will not be returned to you or your doctor.  
Very rarely health or genetic information could be misused by employers, insurance companies, and others. For example, life insurance companies may charge a higher rate based on this information.  
Some states have laws to protect against genetic discrimination [list appropriate state information if your state has such laws]. A federal law called the Genetic Information Non-Discrimination Act, or GINA is in effect. This law does not allow discrimination by insurers or employers. The law does not include other types of misuse by life insurance, disability, or long term care insurance. To learn more about the GINA Law, please ask [Note to local investigator: List contact information here for patient representatives or other individuals who take calls regarding clinical trials but who are not on the site IRB or research team.]
Clinical trial: NCT01302834
Section: Procedures
Subsections: What Will Happen If I Take Part In This Research Study? (6/25/13)|You Will Need These Tests And Procedures In Follow-Up Visits: (10/17/13)

If you participate in this study, you will receive intensity modulated radiation therapy (IMRT). IMRT is a form of radiation in which radiation beams are designed to avoid important normal parts of your body, such as your salivary glands.  
Your doctor also may decide to use a technique called image guided radiation therapy (IGRT). The purpose of IGRT is to give radiation treatment more accurately to your tumor while decreasing the radiation to normal tissues. Small adjustments in your radiation treatment are made each treatment day based on x-ray images taken right before each day's treatment to ensure that your radiation treatment is given as accurately as possible.

These tests and procedures are being done to see how you and your cancer was affected by the treatment you received. These tests and procedures are part of regular cancer care.  
At 1 month after you finish treatment:
A physical examination Examination of the back of your throat and voice box (larynx) with a mirror and/or a flexible lighted tube inserted through your mouth Evaluation of your ability to carry out daily activities Blood tests (about 1 teaspoon of blood will be taken from your vein)
Evaluation of any side effects from treatment you may be having Every 3 months after you finish treatment for 2 years, every 6 months for 3 years, then once a year:
A physical examination Examination of the back of your throat and voice box (larynx) with a mirror and/or a flexible lighted tube inserted through your mouth An evaluation of your diet to see if a feeding tube is needed Evaluation of your ability to carry out daily activities Evaluation of any side effects from treatment you may be having At 1, 2, 5, and 10 years: A dental evaluation After you finish treatment, Once a year for 5 years: A chest CT scan or chest PET/CT scan If your study doctor recommends:
A biopsy to check for recurrence of the cancer Blood tests (about 1 teaspoon of blood will be taken from your vein) Evaluation of any side effects from treatment you may be having A CT scan, MRI, or PET/CT of your neck with contrast A whole body PET/CT with contrast After 5 years, a chest CT scan or chest PET/CT scan once a year
Clinical trial: NCT01302834
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this study is to compare the effects, good and/or bad, of two standard treatments for head and neck cancer: radiation therapy and cisplatin or radiation therapy and cetuximab. The two treatments may be comparable in treating your cancer, but radiation and cetuximab may result in less severe side effects.  
Cisplatin is a classic chemotherapy drug. Cetuximab is a drug that blocks the epidermal growth factor receptor, a protein that affects cancer growth and many other functions. Radiation and cetuximab may result in less severe side effects. However, it is unknown whether it is equally effective as radiation and cisplatin for your type of cancer. This study is being done in patients whose head and neck cancer was caused by Human Papillomavirus Virus (HPV). Some studies have found that patients with HPV positive oropharynx cancer have a better response to treatment and live longer. Thus, this study aims to see if treatment with radiation plus cetuximab has less side effects and is as effective as radiation plus cisplatin.
Clinical trial: NCT01302834
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely.  
It is important to tell the study doctor if you are thinking about stopping so any risks from the radiation and/or cisplatin or cetuximab can be evaluated by him/her. Another reason to tell your study doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you. Another way to find out what will happen to you during the study is to read the chart below. Start reading at the top and read down the list, following the lines and arrows. The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest; if you do not follow the study rules; or if the study is stopped.