Neural Stem Cell Preserving Brain Radiation Therapy & Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases
Condition: Lung Cancer; Breast Cancer; Prostate Cancer
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Intervention: Radiotherapy
Intervention description: Treatments are delivered through parallel opposed or 5 degree RAO/LAO fields that cover the entire cranial contents. There should be beam fall-f of at least 1 cm. The eyes must be excluded from the beam either by field arrangement or shielding.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: whole brain radiotherapy; neural stem cell; brain metastases; radiosurgery

Summary:

      For patients with 1-6 intraparenchymal brain metastases from various primary histologies
      (except for melanoma), stereotactic radiosurgery (administered upfront or concurrently) or
      complete surgical resection with neural stem cell (NSC)-preserving whole-brain radiotherapy
      (WBRT) results in improved neurocognitive profile over standard WBRT. The goal of this study
      is to assess feasibility of this treatment approach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed non-melanoma primary malignancy with 1-6 intraparenchymal
             brain metastases (or small cell lung cancer being considered for prophylactic brain
             irradiation (PBI) with no demonstrable intracranial lesions).

          -  A diagnostic contrast-enhanced magnetic resonance imaging (MRI) demonstrating the
             presence of 1-6 brain metastases performed within 4 weeks of registration. Note: If
             small cell lung cancer primary and patient being considered for PBI, MRI must
             demonstrate no intracranial lesions.

          -  Patients with totally resected intraparenchymal brain metastases; not all lesions need
             be resected if all other criteria are satisfied (no more than 6 total lesions)

          -  The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and
             must have maximum diameter of no more than 4 cm in any dimension on the enhanced scan.
             If multiple lesions are present and one lesion is at the maximum diameter, the
             other(s) must not exceed 3.0 cm in maximum diameter.

          -  Metastatic lesions must be distributed peripherally, that is, at least 0.5 cm lateral
             (outside) of the lateral ventricles and/or hippocampus bilaterally. Posterior fossa
             metastatic lesions are allowed in the study.

          -  Age 18 years or older.

          -  Zubrod performance score 0-1.

          -  Neurologic function score 0, 1, or 2.

          -  Patients receiving glucocorticoids should be tapered to the lowest possible dose, or
             altogether, as judged by the participating physician. If glucocorticoid dose is
             adjusted or given for the first time, patient must remain on stable dose of
             glucocorticoids for at least 3 days prior to initial Neurocognitive Assessment
             Protocol (NAP), CT and MR imaging.

        Exclusion Criteria:

          -  Major medical illnesses or psychiatric impairments, which in the investigators opinion
             will prevent administration or completion of the protocol therapy and/or interfere
             with follow-up.

          -  For patients who have undergone subtotal resection, residual disease must be 4 cm in
             maximum diameter.

          -  Inability to obtain histologic proof of primary malignancy.

          -  Patients with leptomeningial metastases documented by MRI or cerebral spinal fluid
             (CSF) evaluation.