Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases



Status:Active, not recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Cancer, Cancer, Cognitive Studies
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:July 2006

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Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases

RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause
less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells.
It is not yet known whether stereotactic radiation therapy is more effective with or without
whole-brain radiation therapy in treating patients with brain metastases.

PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and
whole-brain radiation therapy to see how well they work compared with stereotactic radiation
therapy alone in treating patients with brain metastases.

OBJECTIVES:

Primary

- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with
stereotactic radiosurgery with vs without whole-brain radiotherapy.

Secondary

- Compare time to CNS (brain) failure in patients treated with these regimens.

- Compare quality of life, duration of functional independence, and long-term
neurocognitive status of patients treated with these regimens.

- Compare post-treatment toxicity in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for
> 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo stereotactic radiosurgery (SRS).

- Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo
whole-brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life, functional independence, and neurocognitive status are assessed at baseline,
at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48,
and 60 months.

PROJECTED ACCRUAL: A total of 238 patients will be accrued for this protocol.

DISEASE CHARACTERISTICS:

- Diagnosis of cerebral metastases meeting the following criteria:

- One to three presumed brain metastases

- Metastases must be from a histologically confirmed extracerebral site (e.g.,
lung, breast, prostate)

- Histologic confirmation may have been from the primary tumor site, from
another metastatic site (e.g., osseous metastasis, adrenal metastasis), or
from the metastatic brain lesion(s)

- Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed
within the past 21 days

- Lesions must not be within 5 mm of the optic chiasm or within the brainstem

- Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery
confirmed by a radiation oncologist

- No primary germ cell tumor, small cell carcinoma, or lymphoma

- No leptomeningeal metastases

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Male or female

- Menopausal status not specified

- ECOG performance status 0-2

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Male patients must continue to use contraception for 3 months after the
completion of radiotherapy

- No pacemaker or other MRI-incompatible metal in the body

- No known allergy to gadolinium

PRIOR CONCURRENT THERAPY:

- More than 7 days since prior and no concurrent chemotherapy

- No prior cranial radiotherapy

- No prior resection of cerebral metastases

- Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
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