Comparing radiation therapy to usual treatment for patients with high-risk bone metastases that are not causing pain

People who have metastatic cancer that has spread to their bones and is considered ‘high risk’ however it is not currently causing pain.

This study is being done to answer the following question: Will preventative radiation therapy lower the number of bone metastases-related complications (such as fracture caused by the tumor in the bone and tumor pushing on the spinal cord) compared to the usual approach?

If you decide to take part in this study, you will either get the usual approach or you will get radiation therapy for up to 5 days plus the usual approach.

The usual approach for patients who are not in a study is drugs that prevent bone loss, in addition to continuing to receive drug treatment for their primary cancer, or observation, which means no treatment unless they start to have symptoms.

If you choose to take part in this study, there is a risk that the radiation therapy may not be as good as the usual approach at reducing the number of bone metastases-related complications in your cancer type. There is also a risk that you could have side effects from the radiation therapy. There is also a risk that you could have side effects from the radiation therapy. These side effects may be worse and may be different than you would get with the usual approach for bone metastases. There may be some risks that the study doctors do not yet know about.

There is evidence that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications in your type of cancer. It is not possible to know now if this approach will decrease the chance of bone metastases-related complications compared to the usual approach. This study will help the study doctors learn things that will help people in the future.

After you finish treatment, your doctor and study team will continue to follow your condition and watch you for side effects. They will check in with you 3, 6, 12, and 24 months after you join the study.

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 bone metastases.

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 drugs to prevent bone loss. 
• the costs of getting 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. 
• 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 Community Oncology Research Program (NCORP) and the groups it works with to conduct research, including the Imaging and Radiation Oncology Core (IROC). 
• VisionTree, Inc. (if you consent to completing questionnaires electronically your responses to questionnaires will be collected).

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:

physician offices

hospitals

clinics

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