Clinical trial: NCT00956007
Section: Alternatives
Subsections: What Other Choices Do I Have If I Do Not Take Part In This Study?

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 Talk to your study doctor about your choices before you decide if you will take part in this study.
Clinical trial: NCT00956007
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Private? (26-Jan-2018)

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
- Other organizations in the National Clinical Trials Network (NCTN): Alliance for Clinical Trials in Oncology (ALLIANCE), ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), and SWOG
- 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
- The Central Institutional Review Board (CIRB)
- Qualified representatives of Eli Lilly and Company or its local affiliate. - VisionTree Software, Inc.  
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: NCT00956007
Section: Duration of Study Involvement
Subsections: How Many People Will Take Part In The Study?|Study Plan How Long Will I Be In The Study?

About 700 people will take part in this study.  
WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY? (4/7/14)
For all patients: Your study doctor will need to send some of your tumor tissue (obtained when you had surgery) to be tested for EGFR expression. Epidermal growth factor receptor (EGFR) is a protein found on the surface of cells, which can start reactions that cause cancer cells to grow. Some studies have suggested that patients with high EGFR have a better response to treatment. This tissue submission for testing is required for this study to see if the results of this test can predict patients' response to the cetuximab.  
For patients with oropharynx cancer: Your tumor tissue also will be tested for the Human Papillomavirus (HPV). This tissue test is required for this study. Some studies have suggested that HPV-related cancer is biologically and clinically different as compared to non-HPV-related cancer. Some studies have found that patients with HPV-related oropharynx cancer have a better response to treatment. This test will help researchers learn more about HPV-related cancer.  
After you have completed treatment on this study, your study doctor can request your EGFR level and/or HPV status from NRG Oncology and discuss it with you.  
Eligible participants will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can choose the group you will be in. You will have an equal chance of being placed in either group.  
If you are in Group 1 (often called "Arm 1"), you will receive radiation therapy once a day, Monday through Friday, for about 6 weeks.  
If you are in Group 2 (often called "Arm 2"), you will receive radiation therapy once a day, Monday through Friday, for about 6 weeks and cetuximab, (an initial dose 1 week prior to radiation and then once a week during radiation for a total of 7 doses). You also will receive cetuximab after you finish radiation therapy, once a week for 4 doses.

Group 1 patients will receive radiation therapy for about 6 weeks.  
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 after radiation therapy, once a week for 4 weeks - a total of 11 weeks of treatment.  
All patients will be asked to visit the office for a follow-up exam one month after finishing radiation therapy with or without cetuximab, then will be seen every 3 months from the end of radiation therapy for 2 years, every 6 months for 3 years, and then once a year for their lifetimes.
Clinical trial: NCT00956007
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. 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: NCT00956007
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect From Being In The Study? (1/25/16)|Possible Side Effects Of **Radiation To The Head And Neck** Common, Some May Be Serious In 100 People Receiving Radiation To The Head And Neck, More Than 20 And Up To 100 May Have: - Sores In The Mouth And Throat Which May Be Painful Especially With Swallowing - Dry Mouth, Changes In Taste, Reduced Sense Of Smell—May Be Permanent - Thick Saliva - Hoarseness - Skin Changes That May Be Permanent, Swelling And Redness Of The Skin In The Area Of Radiation - Pain Or Pressure In The Ear - Tiredness - Weight Loss - Permanent Hair Loss In The Area Of Radiation (Face, Chin, Neck) - Cavities, Tooth Decay; Loss Of Teeth; Tooth Sensitivity Occasional, Some May Be Serious|Rare, And Serious|Possible Side Effects Of Cetuximab (Table Version Date: May 28, 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|Reproductive Risks (12/6/10)|What Happens If I Am Injured Because I Took Part In This Study?|Risks

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 the 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.

In 100 people receiving radiation to the head and neck, from 4 to 20 may have:
- Decrease in function of the thyroid gland that may require you to take thyroid replacement medicine
- Damage to the nerves of the shoulder and arm which may cause decreased movement and feeling
- Ear infection - Hearing loss
- Difficulty swallowing which may require a long term or permanent feeding tube

In 100 people receiving radiation to the head and neck, 3 or fewer may have:
- Breathing and swallowing problems that may require a surgical procedure to create an opening through the neck into the windpipe
- Damage to the nerves in the head and neck that control sensation, expression, or other motor functions
- Damage to the jawbone which may cause jaw pain and loosening of teeth
- Damage to the voice box or nerves to the voice box which may cause hoarseness, shortness of breath, inability to speak
- Damage to the skin, soft tissues, or other parts of the head and neck that may require a major operation to correct and, rarely, can be life threatening
- Damage to the spinal cord which may cause permanent weakness

OCCASIONAL, SOME MAY BE SERIOUS
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 Risks Associated with Cetuximab and Radiation Therapy 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 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 posttreatment 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: NCT00956007
Section: Procedures
Subsections: (6/4/10) **During The Study:**|(11/15/11) **You Will Need These Tests And Procedures In Follow-Up Visits:**

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. At week 1 during radiation or radiation plus cetuximab
- A blood test (about 1 teaspoon of blood will be taken from your vein)
Weekly during radiation or radiation plus cetuximab:
- A physical examination by several doctors
- Evaluation of your ability to carry out daily activities
- Evaluation of any side effects from treatment you may be having Every 3 weeks during radiation or radiation plus cetuximab, and during cetuximab after radiation is completed:
- Blood tests (about 1 teaspoon of blood will be taken from your vein)
If your study doctor recommends:
- CT scan with contrast, or CT/PET scan, and/or MRI of your head and neck
- A chest x-ray or chest CT scan or chest CT/PET scan
- A biopsy to check for recurrence of the cancer

They 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.  
For Patients Receiving Cetuximab: After you finish taking cetuximab, you will have blood tests every 3 weeks for a total of 9 weeks (about 1 teaspoon of blood will be taken from your vein).  
For All Patients: At 1 month after you finish radiation therapy (with or without cetuximab):
- A physical examination
- Evaluation of your ability to carry out daily activities - Blood tests (about 1 teaspoon of blood will be taken from your vein)
- An evaluation of your ability to chew and swallow
- Evaluation of any side effects from treatment you may be having - If your study doctor recommends: Examination of the back of your throat and voice box (larynx)
with a mirror and/or a flexible lighted tube inserted through your mouth For All Patients: Every 3 months from the end of radiation therapy for 2 years, every 6 months for 3 years, then once a year:
- A physical examination - Evaluation of your ability to carry out daily activities
- An evaluation of your ability to chew and swallow
- Evaluation of any side effects from treatment you may be having
- If your study doctor recommends:
➢ Examination of the back of your throat and voice box (larynx) with a mirror and/or a flexible lighted tube inserted through your mouth
➢ A CT scan with contrast, or CT/PET scan, and/or MRI of your head and neck For All Patients: Once a year for 5 years:
- A chest x-ray or chest CT scan or chest CT/PET scan For All Patients: If recommended by your study doctor:
- 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
Clinical trial: NCT00956007
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The standard treatment of surgery (which you have had) followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the FDA in 2006 for the treatment of head and neck cancer.  
The purpose of this study is to compare the effects, good and/or bad, of radiation therapy alone with radiation therapy and cetuximab on you and your cancer to find out which is better. In this study, you will get either radiation therapy alone OR radiation therapy and cetuximab.  
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.  
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.
Clinical trial: NCT00956007
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 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.  
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.  
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.