Breast Cancer, Lung Cancer, Prostate Cancer
Conditions
Keywords
whole brain radiotherapy, neural stem cell, brain metastases, radiosurgery
Brief 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.
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.
Interventions
RADIATIONRadiotherapy
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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 months post RT | Brain metastases bi-dimensional area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 months after end of radiation therapy | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from 08/2007 through 07/2008 in Radiation Oncology clinic
Participants by arm
| Arm | Count |
|---|---|
| Neural Stem Cell-Preserving Whole Brain RT Neural Stem Cell-Preserving Whole Brain Radiotherapy | 4 |
| Standard Whole Brain RT Standard Whole Brain Radiotherapy | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Standard Whole Brain RT | Neural Stem Cell-Preserving Whole Brain RT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Continuous | 52.0 years STANDARD_DEVIATION 0 | 67.2 years STANDARD_DEVIATION 9.7 | 59.6 years STANDARD_DEVIATION 0.6 |
| Region of Enrollment United States | 4 participants | 4 participants | 8 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 1 / 4 | 1 / 4 |
Outcome results
Primary
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.
Brain metastases bi-dimensional area
Time frame: 12 months post RT
Population: Not enough patients were enrolled to allow for any meaningful analysis.
Secondary
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
Population: Study terminated early due to poor accrual