Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Condition: Cognitive/Functional Effects; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Brain Neoplasms
Intervention: intensity-modulated radiation therapy
Intervention description: 30 Gy in 10 fractions to the whole brain using intensity-modulated radiation therapy excluding the hippocampal avoidance area. Bilateral hippocampal contours manually generated on the fused planning MRI CT image set by the treating physician according to protocol-specified contouring instructions. Hippocampal avoidance regions generated by three-dimensionally expanding the hippocampal contours by 5 mm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: cognitive/functional effects; tumors metastatic to brain; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.

      PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain
      radiation therapy works in treating patients with brain metastases.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Histologically or cytologically confirmed non-hematopoietic malignancy within the past
             5 years

               -  If histologic proof of malignancy is from > 5 years ago, then a more recent
                  pathological confirmation is required (e.g., from systemic metastatic or brain
                  metastasis)

               -  Patients with metastasis of unknown primary tumor are permitted

          -  Measurable brain metastasis outside a 5-mm margin around either hippocampus on
             gadolinium contrast-enhanced MRI obtained within the past 30 days

          -  Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical
             resection

               -  These treatment options are allowed only at relapse

          -  Patients who have brain metastases at initial presentation allowed and do not need to
             demonstrate 3 months of stable scans

          -  At least 1 week since open biopsy

          -  Karnofsky performance status 70-100%

          -  Fertile patients must use effective contraception

          -  Negative pregnancy test 2 weeks or less prior to study entry

          -  Patients must be English proficient, with patients who speak English as a second
             language eligible

        EXCLUSION CRITERIA:

          -  Small cell lung cancer or germ cell malignancy

          -  Leptomeningeal metastases

          -  Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of
             extracranial metastases

          -  Radiologic evidence of hydrocephalus

          -  Serum creatinine > 1.4 mg/dL within 30 days prior to study entry

          -  Pregnant or nursing

          -  Contraindication to MRI imaging such as implanted metal devices or foreign bodies or
             severe claustrophobia

          -  Severe, active co-morbidity including any of the following:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the past 6 months

               -  Transmural myocardial infarction within the past 6 months

               -  Acute bacterial or fungal infection requiring intravenous antibiotics

               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study therapy

               -  Uncontrolled, clinically significant cardiac arrhythmias

          -  Prior radiotherapy to the brain

          -  Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7
             days