NRG-GU012 (SAMURAI): Can Adding Radiation Therapy to the Usually Prescribed Immune Therapy Increase the Time without your Renal Cell Cancer Getting Worse or Requiring Surgery?

If you over the age of 18 with renal cell cancer that has spread beyond your kidney and surgery is not currently recommended OR you have chosen not to have surgery, you may be able to participate.

Study doctors want to know if they can increase the time without your renal cell cancer getting worse or requiring surgery by adding radiation therapy to the usual immune therapy. We are doing this study because we want to find out if this approach is better than the usual approach for your renal cell cancer. The usual approach is defined as care most people get for renal cell cancer.

If you decide to take part in the study, you will be randomly assigned to one of two possible study groups. Patients in Study Group 1 will receive the usual immune therapy which consists of either 2 immune therapy drugs OR immune therapy plus a targeted therapy drug called a VEGF inhibitor. Patients in Study Group 2 will receive the same immune therapy as in Group 1 with the additional radiation therapy to your kidney tumor. In this trial, there is a higher chance that you will be assigned to Group 2 and a lower chance that you will be assigned to Group 1.

The usual approach for patients with metastatic renal cell cancer who are not having surgery and are not in a study is treatment with immune therapy alone or immune therapy plus a targeted therapy drug called a VEGF inhibitor. There are several immune therapy drug combinations and targeted therapy drugs approved by the Food and Drug Administration (FDA) that are commonly used to treat metastatic renal cell 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 drugs 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.
• The radiation therapy used on this trial may cause side effects such as hair loss in the abdominal area, tiredness, diarrhea, nausea, and more. 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.

There is evidence that the addition of radiation therapy to immune therapy is effective in shrinking or stabilizing your type of cancer. It is not possible to know now if the study approach will extend your life compared to the usual approach. This study will help the study doctors learn things that will help people in the future.

Patients in both Study Groups will receive the usual immune therapy until it is no longer working to control your cancer. Patients in Study Group 2 receiving the additional radiation treatment will be given radiation on 3 different days during week 1-3 of starting immune therapy. If your tumor is smaller after 2 years of treatment, your doctor will discuss potentially stopping treatment with you.

After your treatment is stopped, your doctor and study team will watch you for side effects. They will monitor you every 6 months for 5 years after treatment and then annually for 3 years.

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 immune therapy. 
• the costs of the radiation therapy (if you are in Group 2). 
• the cost of preparing and administrating the study drugs. 
• 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 Institutional 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 (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