IRB Number:

06-003776

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is being done to:
- Compare overall survival and to compare the effects (good and bad) of stereotactic radiosurgery (SRS) to SRS plus whole brain radiation therapy (WBRT) on a patient and his/her brain metastases.
- Find out if adding WBRT to SRS will offer any additional benefit to receiving SRS alone in treating these possible microscopic tumor deposits in the brain. It is not known whether more treatment will be better or worse. There may be microscopic tumor deposits that are not yet visible on imaging (the MRI scan) that may appear in the future.

This study is a clinical trial conducted by the North Central Cancer Treatment Group (NCCTG). Clinical trials are research studies designed to find better ways to treat diseases like cancer.

Who is Eligible to Participate in the Study?

-Diagnosed with cancer somewhere else in the patient's body that has metastasized (spread) to the brain
-Patients must have one to three metastases in their brain

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

As part of the evaluation of a patient's eligibility to take part in this research study, their study doctor will do the following tests/examinations:
- History and physical examination, including a weight, assessment of their ability to perform patient's day-to-day activities, and a neurology examination
- Consultation with a radiation oncologist
- A serum pregnancy test must be obtained within seven days of starting the study if patient is a female of childbearing potential. Approximately 1 teaspoon of blood will be drawn from a vein by a needle stick.
- MRI scan needs to be done within three weeks prior to signing up for the study. The results of the MRI must show that patients have at least one but no more than three brain metastases and that none are more than approximately 1 inch in size (a little larger than a quarter). If there are more than three brain metastases or if any of the brain metastases are larger than approximately 1 inch in size on patient's pretreatment/planning MRI, patients will not be eligible for this research study.
- Patient's study doctor must also verify that the patient is not having uncontrolled growth of cancer that is outside of their brain.
- Patients will be asked to complete a questionnaire that will take an additional 10-15 minutes before they begin the study. The questionnaire asks how they feel physically, socially, emotionally and functionally.

If patients are eligible and agree to participate, they will be randomized into one of two treatment groups. The two treatment groups are described by the procedures that will be tested in this study are (Group A) SRS and (Group B) SRS plus WBRT. Everyone in this research study will have SRS.

Randomization means that patients are put into a group by chance. It is like flipping a coin. Neither the patient nor their study doctor will choose what group they will be in. The group patients are put in is chosen by a computer. They will have a 50-50 chance of being in one or the other of the two treatment groups (Group A or Group B).

There are procedures that are part of regular cancer care that may be done even if patients do not join the study. If they participate in this research study, some of these tests may be done more frequently than if they were not taking part in this research study.

Groups A and B--SRS
Stereotatic radiosurgery utilizes immobilization (a head frame or a soft plastic mask that forms to the shape of a patient's face that helps hold the head in place during treatment) to allow very precise targeting of tumors. Stereotactic radiosurgery is a single treatment and will be done as an outpatient procedure in most cases. A high dose of radiation will be delivered to a small, focused area of a patient's brain.

One technique, called the "gamma knife," uses gamma rays. Other systems use a specially designed X-ray machine called a linear accelerator. This machine works much like a regular X-ray machine, but the X-ray dose is much higher and the machine will target the tumor. Either a gamma knife or a linear accelerator can be used in this research study.

If a head frame is used, patients will be given a local anesthesia to numb their skin and make it easier to position the special head frame. The head frame must be fixed in place with pins partially extending into their skull. The head frame holds their head to prevent it from moving and to focus the gamma rays or X-rays and aim them at the tumor(s) in their brain. To plan the procedure, a MRI is done while the patient is wearing the head frame. Patients may be given a steroid medicine through a needle into a vein in their arm before the radiosurgery to prevent swelling. For most patients, the actual time on the radiosurgery treatment machine is in the range of 30 to 90 minutes. The head frame will be removed after the treatment and the frame attachment sites on their head will be cleaned. Although extremely rare, there is a possibility that the patient would remain in the head frame between treatments in the event that more than one treatment is necessary.

If a facemask is used, this will be placed over the patient's face to keep their head from moving during the procedure. During the procedure, they will also confirm the exact location that needs to be treated using X-rays. For most patients, the actual time on the radiosurgery treatment machine is in the range of 30 to 90 minutes. The facemask will be removed after the treatment.

Group B only - WBRT
Whole brain radiation therapy will be given to the patient as an outpatient (must start within 14 days after completion of their stereotatic radiosurgery) for five days a week for approximately two and one half weeks (about 12 treatments). The treatments will deliver small doses of radiation to the whole brain each treatment day. The treatments typically last anywhere from 10 to 20 minutes (and part of this time includes making adjustments to accurately target the whole brain). The treatment will use a specially designed X-ray machine called a linear accelerator. This machine works much like a regular X-ray machine, but the targeting is more specific and the X-ray dosage is much higher. The linear accelerator will deliver the radiation with X-ray beams on each side of a patient's head.

The treatment is painless and bloodless, and there is no danger of infection. No head frame is used for WBRT although a soft plastic mask that helps hold the head in place during treatment may be used.

Follow-up Visits
Regardless of which treatment group patients are in (Group A or Group B), they will be asked to visit their study doctor for follow-up visits after their radiosurgery treatment is completed. These follow-up visits will be at six weeks, 12 weeks, six months, nine months, 12 months, 16 months, 24 months and then every year until it has been five years since the patient started the study. During these visits their study doctor or a member of the research team will talk with the patient about their symptoms, give the patient a physical and neurological examination and they will have a MRI scan. Patients will be asked questions to determine their ability to think and remember, and they will be asked questions about their daily living activities. These questions will take approximately 20 to 30 minutes to complete.

In addition to the questions that their study doctor will ask the patient, they will be asked to complete a questionnaire at each follow-up visit after their treatment. The questionnaire asks how they feel physically, socially, emotionally and functionally.

How long will the Study run?

Patients will be in the study for five years after they begin this study to look for any long-term effects of the treatment in this study.

Sponsor(s): North Central Cancer Treatment Group (NCCTG)

Study Activation/Registration Date: 11/15/2006

IRB Review and Approval Date: 10/13/2006

Study Type: Treatment

Projected Accrual: The plan is to have up to 458 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Paul D. Brown, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL

Last updated: 10/13/2008