NRG-HN009: Comparing Two Cisplatin Dosing Schedules Combined with Radiation for Patients with Advanced Head and Neck Cancer

If you over the age of 18 with advanced head and neck cancer, you may be able to participate.

This study has two parts.

Part one of this study is being done to determine if cisplatin given every week with radiation has fewer side effects than cisplatin given every three weeks with radiation. If cisplatin given every week does have fewer side effects, then researchers will move to the next part of the study.

Part two of the study will answer if cisplatin given every week with radiation can extend your life by at least the same amount of time as cisplatin given every three weeks with radiation.

We are doing this study because we want to find out if the cisplatin given every week is the same or better than the cisplatin given every three weeks for your type of cancer.

If you decide to take part in this study, you will be assigned to one of two study groups depending on the location of your head and neck cancer and if you have oropharynx cancer or cancer of unknown primary origin that is related to human papillomavirus (HPV). Both study groups will receive the same treatment options. Patients in both groups will either get radiation for 7 weeks and cisplatin every 3 weeks for up to 7 weeks, or you will get radiation for 7 weeks and cisplatin every week for up to 7 weeks.

The usual approach is defined as care most people get for your type of head and neck cancer. The usual approach for patients who are not in this study is treatment with radiation therapy combined with the chemotherapy drug cisplatin. Cisplatin is a drug approved by the Food and Drug Administration (FDA) to treat your head and neck cancer. Cisplatin can be given at different doses and at different times during radiation, but the most common way to give cisplatin is either every 3 weeks or every week during radiation. For patients who get the usual approach for this cancer, about 20-70 out of 100 are free of cancer after 5 years depending on the location of cancer and other medical conditions. Your study doctor will talk to you more about your cancer.

If you choose to take part in this study, there is a risk that:

• 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. 
• The study approach may not be as good as the usual approach for your cancer at shrinking or stabilizing your cancer and preventing your cancer from spreading. 
• The drugs used on this trial may cause side effects. Your doctor will review all of the potential side effects with you. It is important to tell your doctor about any side effects during the study so that they may be treated and so that potential adjustments to the study drugs may be made.

There is evidence that radiation with cisplatin given every week is effective in shrinking or stabilizing your cancer or preventing your cancer from coming back. It is not possible to know now if this approach will cause fewer sides effects or be as good at extending your life compared to the other usual approach, which is radiation with cisplatin given every 3 weeks. This study will help the study doctors learn things that will help people in the future.

Both groups will receive their treatment for 7 weeks.

After you finish treatment, your doctor will continue to follow your condition and watch you for side effects. They will check you at 1 month after treatment ends and then 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. 
• the costs of the cisplatin drug 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:

• 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, 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 and 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 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