stereotactic radiation therapy with or without whole-brain radiation therapy in treating patients with brain metastases

Conditions: Breast Cancer; Cognitive/Functional Effects; Lung Cancer; Metastatic Cancer; Prostate Cancer

Summary: 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.

Eligibility criteria:
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

Keywords: cognitive/functional effects tumors metastatic to brain stage iv breast cancer stage iv prostate cancer stage iv non-small cell lung cancer male breast cancer recurrent breast cancer recurrent prostate cancer recurrent non-small cell lung cancer