NRG-RTOG 1216: Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer

Men and women 18 and older, who have a proven diagnosis of head and neck squamous cell carcinoma involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx, may be eligible for the study.

The first part of this study was done to answer the following question: Which experimental docetaxel arm with radiation therapy (docetaxel alone or docetaxel with cetuximab) will be better as compared to the standard approach? The first part of the study was completed. The initial results showed that docetaxel and cetuximab plus radiation therapy was better than the docetaxel alone plus radiation therapy in controlling your type of cancer.

You are now being asked to participate in the second part of this study. We are doing the second part of this study because we want to find out if radiation therapy with docetaxel and cetuximab or radiation therapy with cisplatin and an immunotherapy drug, atezolizumab, is better than the usual approach for your high-risk head and neck cancer. The usual approach is defined as care most people get for high-risk head and neck cancer.

If you decide to take part in this study, you will either get:

• Usual approach of radiation therapy with cisplatin chemotherapy OR 
• Radiation therapy with docetaxel and cetuximab chemotherapy OR 
• Radiation therapy with cisplatin chemotherapy and the study drug, atezolizumab, which is an immunotherapy drug.

After surgery, the usual approach for patients who are not in a study is the combination of radiation therapy and cisplatin chemotherapy. The combination of radiation therapy and cisplatin is FDA approved for treating head and neck cancer. In 100 people who receive the usual approach for your cancer, about 30 or 40 will be free of this cancer at 5 years.

If you choose to take part in this study, there is a risk that the study approach may not be as good as the usual approach for your cancer. There is also a risk that you could have side effects from the study approach. Your doctor will review all of the potential side effects with you. There may be some risks that the study doctors do not yet know about.

There is evidence that the study drug, atezolizumab, is effective in shrinking or stabilizing your type of cancer. It is not possible to know now if the study approach is better than the usual 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 watch you for side effects. They will check you 1 month after treatment, 3 months after treatment, and every 3 months for 2 years after treatment. After that, they will check you every 6 months for 3 years, then annually.

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. If you are receiving atezolizumab, the extra blood tests to monitor thyroid function and organ function will be billed to your health care plan/insurance provider. 
• the costs of cisplatin drug and administration. 
• the costs of docetaxel drug and administration. 
• the costs of cetuximab drug and administration. 
• the costs of getting the atezolizumab ready and giving it to you. 
• 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:

• NRG Oncology and any company supporting the study now or in the future. This would include any organization helping the company with the study. 
• 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 and the groups it works with to review research. 
• The NCI and the groups it works with to review research, including the Cancer Support Trials 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