Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases
Condition: Brain Neoplasms, Adult, Malignant
MeSH terms: Brain Neoplasms
Intervention: Radiotherapy
Intervention description: Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The investigators hypothesize that avoidance of the hippocampal region with WBRT (Whole-Brain
      Radiotherapy ) may delay or reduce the onset, frequency, and/or severity of NCF
      (neurocognitive function) decline, as measured with clinical neurocognitive tools.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pathologically (histologically or cytologically) proven diagnosis of a
             non-hematopoietic malignancy other than small cell lung cancer and germ cell
             malignancy.. Direct biopsy of CNS (central nervous system) lesions is not necessarily
             required although could constitute an allowed site of tissue confirmation as medically
             prudent. Patients who have been disease free for more than 5 years prior to the
             appearance of CNS metastases should undergo repeat biopsy of either a systemic
             metastasis or the CNS metastases to confirm the recurrent malignancy.

          2. Patients with measurable brain metastasis outside a 5-mm margin around either
             hippocampus

          3. Patients with measurable brain metastasis who have not been or will not be treated
             with SRS (stereotactic radiosurgery ) or surgical resection (Note: These treatment
             options are only permitted at relapse)

          4. History/physical examination within 28 days prior to registration

          5. Patients must fall into RTOG (Radiation Therapy Oncology Group) recursive partitioning
             analysis (RPA) class I or II

          6. Patients must have a life expectancy of at least 4 months.

          7. Age ≥ 18 years

          8. Karnofsky performance status ≥ 70

          9. Patients must provide study-specific informed consent prior to study entry

         10. Women of childbearing potential and male participants must practice adequate
             contraception

         11. Women of childbearing potential must have a negative, qualitative serum pregnancy test
             ≤2 weeks prior to study entry

        Exclusion Criteria:

          1. Patients with greater than 9 discrete metastases on MRI.

          2. Patients with leptomeningeal metastases

          3. Patients with measurable brain metastasis not resulting from small cell lung cancer
             and germ cell malignancy

          4. Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days

          5. Contraindication to MR (Magnetic resonance) imaging such as implanted metal devices or
             foreign bodies, severe claustrophobia AND patients unable to receive gadolinium
             contrast agents

          6. Serum creatinine > 1.4 mg/dl ≤ 28 days prior to study entry

          7. Prior radiation therapy to the brain

          8. Patients planning to undergo radiosurgery to any CNS lesion OR patients planning to
             have surgical resection of ALL of their CNS lesions