IRB Number
|
2003-227
|
| Description |
The main purpose of this study is to compare
overall survival and to compare the good and bad effects of radiosurgery
(RS) to radiosurgery plus whole brain radiation therapy (WBRT) on you and
your brain metastases. This
research study is being done because we do not know if adding WBRT to RS
will offer any additional benefit to receiving RS alone. |
| What is expected of me? |
The subject must permit the collection of data
and follow-up of how he/she is responding to therapy. You will receive your standard cancer care and the study
doctor or a member of the research team will talk with the participant
about symptoms, do a physical/nervous
system examination and a MRI scan. Questions
to determine their ability to think and remember, and about their daily
living activities. A
questionnaire will be completed prior to treatment and at each follow-up
visit after treatment. The
questionnaire asks about your relationship with the study doctor and how
they feel physically, socially, emotionally and functionally. |
| Inclusion Criteria |
Participants must have and ECOG/Zubrod performance
status of 0, 1, or 2 Patient must present de novo with one to three
presumed brain metastases from a histologically confirmed extra-cerebral
primary tumor site, from another metastatic site or from the metastatic
brain lesion(s). |
| Exclusion Criteria |
Patient has
pacemaker or other MRI non-compatible metal in the body Patient has a
known allergy to gadolinium. Patient has had a prior resection of cerebral
metastasis. Patient has a lesion that is located the optic chiasm or
within the brainstem.
Patient has had chemotherapy within 21 days prior to radiosurgery. Patient
has had prior cranial radiation therapy Patient has a primary germ
cell tumor, small cell carcinoma, or lymphoma. Patient
has a leptomeningeal metastasis. |
| Length of Study |
Indefinite |
| Study Location |
Penn State Milton S. Hershey Medical Center |
| Investigator Information |
Jonas Sheehan, MD – Surgery |
| To obtain more information about this study please contact: |
Deborah Hoffman
dlhoffman@hmc.psu.edu
717 531 0003, x283063 |
