NRG-BN003: Comparing Observation Versus Radiation for Newly Diagnosed Grade II Meningiomas That Appear to Have Been Completely Removed Through Surgery

If you are over the age of 18 and have a grade II meningioma that has been completely removed through surgery, you may be able to participate.

This study is being done to compare any good and bad effects of using radiation to treat a meningioma that has been completely removed compared with the more common approach of observing the tumor and treating it with radiation if it returns. Researchers want to know if radiation therapy following surgery is better than observation alone.

If you decide to take part in this study, you will have surgery then you will either be observed without any radiation treatment (Group 1) or you will receive radiation therapy to the area of the brain where the meningioma was removed with careful attention to minimizing the amount of radiation received by normal tissue (Group 2).

People who are not in a study and who have had a grade II meningioma completely removed may be observed without treatment; treated with radiation following surgery; or treated with radiation therapy only if their tumor comes back. For patients who receive the common approach of observation, about 50 to 75 out of 100 are free of meningioma at three to five years.

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. 
• 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 during the study so that they may be treated and so that potential adjustments to the study drugs may be made.

It is not possible to know at this time if observing you after surgery or treating you with radiation only if the meningioma returns, is better than treating you with radiation immediately after surgery, so this study may or may not help you. This study will help researchers learn things that will help people in the future.

If you are randomized to Group 2, you will receive the radiation therapy 5 days per week for 6 1/2 to 7 weeks (33 treatments). After you finish radiation therapy, your doctor will continue to watch you for side effects and follow your condition through office visits at months 3, 6 and 12 for the first year from randomization, every 6 months for year 2 and 3, then yearly for 10 years. If you are randomized to Group 1 (post-surgery observation), your doctor will follow you through office visits at the same intervals. Patients in both Groups will have MRIs at least every 6 months from randomization for 5 years, then at least yearly for 10 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 health plan/insurance company will need to pay for all of the costs of treating and monitoring your meningioma while in this study, including the cost of tests, procedures, or medicines to manage any side effects, unless you are told that certain tests are supplied at no charge. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for.

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 
• Other organizations in the National Clinical Trials Network (NCTN): Alliance for Clinical Trials in Oncology (ALLIANCE), ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), SWOG, and Imaging and Radiation Oncology Core (IROC) 
• The Institutional Review Board (IRB) 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 National Cancer Institute in the U.S., and similar ones if other countries are involved in the study.

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