Neural Stem Cell Preserving Brain Radiation Therapy & Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases

This study has been terminated.
(New research priorities)
Sponsor:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00581113
First received: December 20, 2007
Last updated: January 27, 2011
Last verified: January 2011

December 20, 2007
January 27, 2011
March 2007
June 2009   (final data collection date for primary 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. [ Time Frame: 12 months post RT ] [ Designated as safety issue: No ]
Brain metastases bi-dimensional area
Neurocognitive Assessment [ Time Frame: 12 months after end of radiation therapy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00581113 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 12 months after end of radiation therapy ] [ Designated as safety issue: No ]
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.
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. [ Time Frame: 12 months after end of radiation therapy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Neural Stem Cell Preserving Brain Radiation Therapy & Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases
A Study of Neural Stem Cell (NSC) Preserving Whole Brain Radiation Therapy (WBRT) and Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lung Cancer
  • Breast Cancer
  • Prostate Cancer
Radiation: Radiotherapy
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.
  • Active Comparator: 1
    Standard Whole Brain Radiotherapy
    Intervention: Radiation: Radiotherapy
  • Experimental: 2
    Neural Stem Cell-Preserving Whole Brain Radiotherapy
    Intervention: Radiation: Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581113
MCC-10655
Yes
Mitchell S. Anscher, MD, Massey Cancer Center/Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Mitchell S. Anscher, MD Massey Cancer Center
Virginia Commonwealth University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP