Whole Brain Radiation Using IMRT for Patients With Brain Metastases

This phase II clinical trial will utilize intensity modulated whole brain radiation therapy
in order to deliver a smaller, yet effective dose for subclinical disease while giving a
higher dose to gross disease for patients with more than one brain metastasis. In this study,
a dose of 30 Gray (Gy) will be prescribed to subclinical sites and 60 or 45 Gy to visible
brain metastases.

There is evidence from previous studies (including Radiation Therapy Oncology Group (RTOG)
0933) that hippocampal avoidance during whole brain radiotherapy using IMRT may decrease
toxicity in the form of memory loss. Patients who had brain metastases within the region of
hippocampal avoidance were not eligible for enrollment on RTOG 0933. In contrast, this study
will include this group of patients since IMRT will be used to not only deliver higher doses
to visible brain metastases even though they are located within the hippocampal avoidance
region, but also to avoid the hippocampus itself. This approach may help to preserve memory
function. Additionally, while temporary (and sometimes permanent) alopecia results from
conventional whole brain radiation, IMRT spares the skin and possibly decreases the rate of
hair loss. Dose to the scalp will be limited to as low as possible in order to decrease the
risk of permanent alopecia in this study.

Inclusion Criteria:

- Pathologically proven diagnosis of a non-hematopoietic malignancy other than small
cell lung cancer and germ cell malignancy within 5 years of registration. Patients
with metastasis of unknown primary tumor are permitted.

- History/physical examination within 30 days prior to registration.

- Age ≥ 18 years

- Karnofsky performance status ≥ 70

- Ability to understand and the willingness to sign a written informed consent document.

- Women of child-bearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry, for the duration of
study participation, and for 90 days following completion of therapy. Should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately.

- Women of childbearing potential must have a negative qualitative serum pregnancy test
≤ 2 weeks prior to study entry. A female of child-bearing potential is any woman
(regardless of sexual orientation, having undergone a tubal ligation, or remaining
celibate by choice) who meets the following criteria: 1) Has not undergone a
hysterectomy or bilateral oophorectomy; or 2) Has not been naturally postmenopausal
for at least 12 consecutive months (i.e., has had menses at any time in the preceding
12 consecutive months).

- More than one brain metastasis (qualifying measurable brain lesions are any contrast
enhancing metastases identifiable by the physician).

- Patients who have undergone a resection for brain metastases will be eligible for
participation if they have any residual metastases present on post operative MRI of
the brain.

Exclusion Criteria:

- Patients with leptomeningeal metastases

- Plan for chemotherapy or targeted therapies during whole brain radiation or within 1
week of completing radiation therapy

- Contraindication to Magnetic Resonance (MR) imaging

- Serum creatinine > 1.4 mg/dl ≤ 30 days prior to study entry

- Prior radiation therapy to the brain besides radiosurgery

- Severe active comorbidities which would make the patient an unacceptable candidate for
this clinical trial per physician discretion

- Patients with brain metastases involving the brainstem or chiasm

- Non English speaking patients