Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Condition: Breast Cancer; Cognitive/Functional Effects; Lung Cancer; Metastatic Cancer; Prostate Cancer
MeSH terms: Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms
Intervention: radiation therapy; stereotactic radiosurgery
Intervention description: Patients undergo radiation therapy 5 days a week for 2.5 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

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