Comparing Observation Versus Radiation for Newly Diagnosed Grade II Meningiomas That Appear to Have Been Completely Removed Through Surgery

If you over the age of 18, you received stereotactic radiosurgery to treat cancer that spread to your brain, and now the cancer has returned in other areas of the brain, and your BMV is four or higher, you may be able to participate.

This study is being done to answer the following question:

Can we extend your life by using a type of radiation therapy called whole-brain radiation (HA-WBRT) therapy that preserves memory by avoiding the hippocampus and using the medication memantine to the usual treatment of SRS?

We are doing this study because we want to find out if HA-WBRT and memantine is better or worse than the usual approach for your brain cancer. The usual approach is defined as care most people get for cancer that has spread to the brain and returned in other areas of the brain after receiving SRS.

If you decide to take part in this study, you will either get treatment with HA-WBRT and memantine, or you will get treatment with SRS.

The usual treatment, SRS, delivers a high dose of radiation only to the small areas of cancer in the brain but does not treat even smaller areas of cancer that cannot be seen in the brain. SRS is a single treatment over one day or a few days as an outpatient procedure.

If you receive HA-WBRT, you will receive it 5 days per week Monday through Friday for about 2 weeks as an outpatient procedure. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampus avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The medicine memantine is also given with HA-WBRT because it decreases the risk of side effects of radiation on thinking and memory.

You will receive memantine as a tablet by mouth for 6 months.

If you do not receive HA-WBRT plus memantine, you will receive the usual SRS treatment as described above.

The usual treatment for your brain cancer is stereotactic radiosurgery, or SRS, that delivers a high dose of radiation only to the small areas of cancer in the brain but does not treat even smaller areas of cancer that cannot be seen in the brain.

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 that you normally do not discuss. 
• The study approach may not be as good as the usual approach at shrinking or stabilizing your cancer and preventing your cancer from spreading. 
• The study approach 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 you may experience during the study so that they may be treated and so that potential adjustments to the study approach may be made.

There is evidence that memantine and HA-WBRT is more effective in preventing the same cancer from growing in other areas of the brain compared to the usual approach of SRS. 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.

After you finish your treatment, your doctor and study team will watch you for side effects and follow your condition. They will check you every 2 to 3 months for at least 1 year after you start treatment. If you are receiving memantine, your doctor will continue to see you in the clinic as needed.

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 stereotactic radiosurgery 
• the costs of the whole-brain radiation therapy and memantine 
• 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 does not 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 and Drug Administration (FDA) and the groups it works with to review research. 
• The National Cancer Institute (NCI) and the groups it works with to review research, including the Cancer Trials Support Unit (CTSU). 
• The NCI’s National Clinical Trials Network (NCTN) 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:

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