Clinical trial: NCT02254278
Section: Alternatives
Subsections: What Is The Usual Approach To My **Cancer?**|What Are My Other Choices If I Do Not Take Part In This Study?

You are being asked to take part in this study because you have oropharyngeal cancer of a specific type that appears to be more sensitive to radiation treatment. People who are not in a study are usually treated with high doses of radiation and chemotherapy. For patients who receive the usual approach for this cancer, about 85 out of 100 are alive and free of cancer at five years. These treatments can result in many side effects both during and after treatment. Your doctor will discuss these with you.

If you decide not to take part in this study, you have other choices. For example:
you may choose to have the usual approach described above you may choose to take part in a different study, if one is available or you may choose not to be treated for cancer but you may want to receive comfort care to relieve symptoms.
Clinical trial: NCT02254278
Section: Confidentiality
Subsections: Who Will See My Medical Information? **(4/29/15)**|How Will Information About Me Be Kept Private?

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database. There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:
NRG Oncology The Institutional Review Board, IRB, is a group of people who review the research with the goal of protecting the people who take part in the study.  
The Food and Drug Administration and the National Cancer Institute in the U.S., and similar ones if other countries are involved in the study.

Your privacy is very important to the researchers and they will make every effort to protect it. Here are just a few of the steps they will take:
1) When your samples are sent to the researchers, no information identifying you (such as your name)
will be sent. Samples will be identified by a unique code only.  
2) The list that links the unique code to your name will be kept separate from your sample and health information. Any Biobank and NRG Oncology staff with access to the list must sign an agreement to keep your identity confidential.  
3) Researchers to whom NRG Oncology sends your sample and information will not know who you are. They must also sign an agreement that they will not try to find out who you are.  
4) Information that identifies you will not be given to anyone, unless required by law. Page 12 5) If research results are published, your name and other personal information will not be used.
Clinical trial: NCT02254278
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study? **(4/29/15)**

Group 1 patients will receive radiation and chemotherapy for 6 weeks. Group 2 patients will receive radiation for 5 weeks. After you finish treatment, your doctor will continue to watch you for side effects, check your disease, and see you in follow-up visits at 1 month after treatment, every 3 months for years 1 and 2, every 6 months for years 3, 4, and 5, then once a year for your lifetime.
Clinical trial: NCT02254278
Section: Participant's Rights
Subsections: What Are My Rights In This Study?

Taking part in this study is your choice. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights. For questions about your rights while in this study, call the ________________________ *(insert name of* center) Institutional Review Board at __________________ *(insert telephone number). (Note to Local* Investigator: Contact information for patient representatives or other individuals at a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can also be listed here.)
Clinical trial: NCT02254278
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Possible Risks Can I Expect From Taking Part In This Study? **(5/17/16)**|Possible Side Effects Of Cisplatin (Table Version Date: May 28, 2013) Common, Some May Be Serious|Occasional, Some May Be Serious|Occasional, Some May Be Serious|Rare, And Serious|Possible Side Effects Of Research Radiation Therapy Common, Some May Be Serious|Occasional, Some May Be Serious|Occasional, Some May Be Serious|What Happens If I Am Injured Or Hurt Because I Took Part **In This Study?**|What Are The Possible Risks?

If you choose to take part in this study, there is a risk that:
The study approach may not be better, and could possibly be worse, than the usual approach for your cancer.  
You may lose time at work or home and spend more time in the hospital or doctor's office than usual You may be asked sensitive or private questions which you normally do not discuss Here are important points about side effects:
The study doctors do not know who will or will not have side effects. Some side effects may go away soon, some may last a long time, or some may never go away.  
Some side effects may interfere with your ability to have children.  
Some side effects may be serious and may even result in death.  
Here are important points about how you and the study doctor can make side effects less of a problem:
Tell the study doctor if you notice or feel anything different so they can see if you are having a side effect.  
The study doctor may be able to treat some side effects. The study doctor may adjust the study drugs to try to reduce side effects.  
The tables below show the most common and the most serious side effects that researchers know about. There might be other side effects that researchers do not yet know about. If important new side effects are found, the study doctor will discuss these with you.

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 Numbness, tingling, or pain of the arms and legs

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

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 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 RARE, AND SERIOUS
In 100 people receiving radiation therapy, 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 Let your study doctor know of any questions you have about possible side effects. You can ask the study doctor questions about side effects at any time. Reproductive risks: You should not get pregnant, breastfeed, or father a baby while in this study. The radiation (and chemotherapy) used in this study could be very damaging to an unborn baby. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your doctor immediately. Both men and women enrolled in this trial must agree to use adequate contraception prior to the study, while being treated on the study, and at least 60 days after finishing study treatment. Check with the study doctor about what types of birth control, or pregnancy prevention, to use while in this study.

In 100 people receiving Cisplatin, 3 or fewer may have:
Cancer of bone marrow later in life caused by chemotherapy Seizure Page 5 Possible risks from exposure to radiation as a result of the tests required to understand the extent of your head and neck cancer and to check the response of your disease to therapy: The following possible risks apply to all patients who are tested and receive the usual treatment for their head and neck cancer, whether they take part in this study or not. All patients that are being treated with modern radiotherapy and are being followed for their head and neck cancer will be exposed to the doses of radiation described below. Overall, the doses of radiation that are being discussed below are very small compared to those that will be delivered to head and neck chest as part of the usual radiotherapy treatment.

In 100 people receiving radiation therapy, more than 20 and up to 100 may have:
Reddening, tanning, or peeling of the skin, which may be permanent Mild pain Hair loss in the area of radiation, which may be permanent Tiredness Weight loss Sores in the mouth and throat, which may be painful especially when swallowing Cavities, tooth decay, loss of teeth, tooth sensitivity Dry mouth, changes in taste, thick saliva, reduced sense of smell—may be permanent Pain or pressure in the ear

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

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 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 RARE, AND SERIOUS
In 100 people receiving radiation therapy, 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 Let your study doctor know of any questions you have about possible side effects. You can ask the study doctor questions about side effects at any time. Reproductive risks: You should not get pregnant, breastfeed, or father a baby while in this study. The radiation (and chemotherapy) used in this study could be very damaging to an unborn baby. If you are a woman and become pregnant or suspect you are pregnant while participating in this study, please inform your doctor immediately. Both men and women enrolled in this trial must agree to use adequate contraception prior to the study, while being treated on the study, and at least 60 days after finishing study treatment. Check with the study doctor about what types of birth control, or pregnancy prevention, to use while in this study.

If you are injured or hurt as a result of taking part in this study and need medical treatment, please tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. Your insurance company may not be willing to pay for study-related injury. If you have no insurance, you would be responsible for any costs.  
If you feel this injury was a result of medical error, you keep all your legal rights to receive payment for this even though you are in a study.

1) The most common risks related to drawing blood from your arm are brief pain and possibly a bruise. 2) There is a risk that someone could get access to the personal information in your medical records or other information researchers have stored about you.  
3) 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: NCT02254278
Section: Procedures
Subsections: What Extra Tests And Procedures Will I Have If I Take Part In **This Study?**

Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra tests, and procedures that you will need to have if you take part in this study.  
1. Your privacy is very important, and the researchers will make every effort to protect it. Your test results will be identified by a unique code, and the list that links the code to your name will be kept separate from your samples and health information. Your test results will be available to your doctor. If any of your tissue is left over from this extra test, it will be stored for biobanking, if you agree. There is more information about biobanking in the optional study section.  
2. Before you begin the study, you are required to fill out a form with questions about your swallowing abilities. It will take you 5-10 minutes. If you can't fill out the form because it is not available in your language, you can still take part in the study.  
3. Before beginning the study, women who can have children must have a negative pregnancy test in order to take part. The radiation therapy (and for group 1 patients, the chemotherapy) used in this study could be very damaging to an unborn baby.
Clinical trial: NCT02254278
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

Previous studies of your type of cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation with or without chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less. For this reason this study is looking at two different ways of reducing the intensity of your treatment. The purpose of this study is to compare any good and bad effects of using lower dose radiation therapy and chemotherapy to using lower dose radiation therapy alone. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at five years) but with less long term side effects.  
There will be about 296 people taking part in this study.
Clinical trial: NCT02254278
Section: Voluntary Participation
Subsections: My Signature **Agreeing To Take Part In The Main Study**

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed copy of this form. I agree to take part in the main study and any additional studies where I circled 'yes'. Participant's signature________________________________ Date of signature_____________________________________ Signature of person(s) conducting the informed consent discussion___________________________________ Page 13 Date of signature_____________________________________
Clinical trial: NCT02254278
Section: Withdrawal from Study
Subsections: Can I Stop Taking Part **In This Study?**|What If I Change My Mind?

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
If your health changes and the study is no longer in your best interest If new information becomes available If you do not follow the study rules If the study is stopped by the sponsor, IRB or FDA.

If you decide you no longer want your samples to be used, you can call the study doctor, _________________,
(insert name of study doctor for main trial) at ________________________ (insert telephone number of study doctor for main trial) who will let the researchers know. Then, any sample that remains in the bank will no longer be used and related health information will no longer be collected. Samples or related information that have already been given to or used by researchers will not be returned.