Trial Information

A Phase III Prospective Randomized Trial Comparing Radiosurgery With Versus Without Whole Brain Radiotherapy for 1-3 Newly Diagnosed Brain Metastases

Before treatment starts, patients will have a complete history (including details of
previous chemotherapy, radiotherapy, and surgery for systemic disease). Patients will have
a complete neuropsychological exam and will have their Karnofsky Performance Score (KPS)
figured out. Seven cognitive function tests and a quality of life (QOL) questionnaire will
be given to the patients as well. It will take about 40 minutes to complete the QOL
questionnaire.

Patients in this study will be randomly picked (as in the toss of a coin) to be in one of
two treatment groups. Patients in one group will receive immediate whole brain radiation
therapy. Patients in the other group will hold off on radiation and just be closely
observed. There is an equal chance of being in either group.

All patients will receive radiosurgery treatment to the known metastases (1-3 lesions) at
the beginning. All participants will be followed with serial diagnostic and functional MRI.
Experimental functional imaging will be used to evaluate short-term memory and picture
recognition as well as blood flow within the brain.

Formal neuropsychological testing will also be performed at each follow-up interval.
Patients must come back at 4 months for neuropsychological testing. Patients will be seen
for follow-up with neuropsychological evaluation, as well as diagnostic/function MRI at 1 ,
2 , 4 , 6 , 9 , 12 , 15 , and 18 months and then every six months from then on. Each visit
will require about 40 minutes of time.

Cost information related to protocol treatment and subsequent therapies will be tracked and
collected for cost analysis between the two treatment groups.

Patients who did not receive whole brain radiation and develop recurrent disease shall
receive treatment based on the number of lesions. If there are greater than 2 lesions,
whole brain radiation will be given. If there are 1-2 lesions, patients will be randomly
assigned to a local treatment (surgery or radiosurgery) or whole brain radiation therapy.
Further recurrences in patients having not yet received whole brain radiation will be given
this treatment at the time of recurrence.

The expected length of the study is 3.8 years with 6 months follow-up following the end of
the study. Thus, the length of participation can range from 6 months for patients enrolling
at the end of the study to over 4 years for patients enrolling at the beginning.

This is an investigational study. A total of 152 patients will take part in the study. All
will be enrolled at MD Anderson.