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A Study of Neural Stem Cell (NSC) Preserving Whole Brain Radiation Therapy (WBRT) and Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases

Phase 3
18 Years
Not Enrolling
Lung Cancer, Breast Cancer, Prostate Cancer

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Trial Information

A Study of Neural Stem Cell (NSC) Preserving Whole Brain Radiation Therapy (WBRT) and Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases

Cancer patients (except patients with melanoma) with 1-6 brain metastases are randomized to
receive standard whole brain radiation therapy or whole brain radiation therapy in a neural
stem cell-preserving manner.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.

Outcome Description:

Brain metastases bi-dimensional area

Outcome Time Frame:

12 months post RT

Safety Issue:


Principal Investigator

Mitchell S. Anscher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

June 2009

Related Keywords:

  • Lung Cancer
  • Breast Cancer
  • Prostate Cancer
  • whole brain radiotherapy
  • neural stem cell
  • brain metastases
  • radiosurgery
  • Breast Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Brain Neoplasms



Massey Cancer Center/Virginia Commonwealth UniversityRichmond, Virginia  23298