Comparing radiation plus cetuximab to radiation plus chemotherapy in people with advanced head and neck cancer who cannot receive cisplatin.

People who have advanced head and neck cancer and are unable to receive one of the standard chemotherapy treatments called cisplatin.

This study is being done to answer the following question: Does the usual approach of radiation therapy plus the chemotherapy drugs carboplatin and paclitaxel extend the time without your cancer getting worse compared to the usual approach of radiation therapy and cetuximab?

If you decide to take part in this study, you will either get the usual radiation therapy plus cetuximab for 8 weeks, or you will get the usual radiation therapy plus carboplatin and paclitaxel chemotherapy for 7 weeks.

The usual approach for patients who are unable to receive cisplatin and who are not in a study is treatment with radiation therapy combined with either chemotherapy, such as carboplatin and paclitaxel, or an anti-cancer drug such as cetuximab. Cetuximab is an antibody that specifically targets cancer cells. There are several other targeted therapy drugs and other chemotherapy drugs approved by the Food and Drug Administration (FDA) that are commonly used with the radiation therapy. For patients who get the usual approach for this cancer, about 35 out of 100 are free of cancer after 2 years.

If you choose to take part in this study, there is a risk that the usual approach of radiation plus chemotherapy may not be as good as the usual approach of radiation plus cetuximab at shrinking or stabilizing your cancer. There is also a risk that you could have side effects from the chemotherapy or cetuximab. These side effects may be worse and may be different than you would get with the usual approach for your cancer. There may be some risks that the study doctors do not yet know about.

There is evidence that both study drug therapies, chemotherapy or cetuximab, plus radiation are effective in shrinking or stabilizing your type of cancer. It is not possible to know now if the radiation plus chemotherapy approach will extend your time without disease getting worse compared to the radiation plus cetuximab approach. This study will help the study doctors learn things that will help people in the future.

After you finish your treatment, your doctor and study team will continue to follow your condition and watch you for side effects. They will check you at 4 months, 6 months, and then every 6 months up until year 3 after you finish treatment. After that, they will continue to follow your condition annually for your lifetime.

No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you are able to leave the study at any time. If you decide not to take part in this study, your doctor will discuss other treatment options with you.

You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer.

This includes:

• the costs of tests, exams, procedures, and drugs that you get during the study to monitor your safety, and prevent and treat side effects.
• the cetuximab (if you are in Group 1) or chemotherapy (if you are in Group 2), including the costs of getting it ready and giving it to you.
• the radiation therapy
• your insurance co-pays and deductibles.

Talk to your insurance provider and make sure that you understand what your insurance pays for and what it doesn’t pay for if you take part in this clinical trial.  Also, find out if you need approval from your plan before you can take part in the study.

You will not be paid for taking part in this study.

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 specimens 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:

• The study sponsor, NRG Oncology.
• The National Cancer Institute (NCI) Central Investigational Review Board (IRB), which is a group of people who review the research with the goal of protecting the people who take part in the study.
• The Food & Drug Administration (FDA) and the groups it works with to review research.
• The NCI and the groups it works with to review research, including the Cancer Trials Support Unit (CTSU).
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research including the Imaging and Radiation Oncology Core (IROC).

Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.

Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials“.

• You may choose to have the usual treatment approach (known as “standard of care”)
• You may choose to take part or learn more about a different study, if one is available
• You may choose not to be treated for cancer