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:
Virginia Commonwealth University
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00581113
First received: December 20, 2007
Last updated: January 27, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Breast Cancer Prostate Cancer |
Radiation: Radiotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Neural Stem Cell (NSC) Preserving Whole Brain Radiation Therapy (WBRT) and Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases |
Resource links provided by NLM:
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Enrollment: | 8 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Standard Whole Brain Radiotherapy
|
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.
|
|
Experimental: 2
Neural Stem Cell-Preserving Whole Brain Radiotherapy
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581113
Locations
| United States, Virginia | |
| Massey Cancer Center/Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
| Principal Investigator: | Mitchell S. Anscher, MD | Massey Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mitchell S. Anscher, MD, Massey Cancer Center/Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00581113 History of Changes |
| Other Study ID Numbers: | MCC-10655 |
| Study First Received: | December 20, 2007 |
| Results First Received: | October 6, 2010 |
| Last Updated: | January 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
|
whole brain radiotherapy neural stem cell brain metastases radiosurgery |
Additional relevant MeSH terms:
|
Breast Neoplasms Lung Neoplasms Neoplasm Metastasis Prostatic Neoplasms Brain Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013