Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
tumors metastatic to brain, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases
Detailed description
OBJECTIVES: Primary * To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases. Secondary * To determine the overall survival rate at 6 months. * To determine the progression-free survival rate or brain metastases recurrence rate at 6 months. * To determine the time to neurological death, time to systemic death, and Karnofsky decay time. * To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy. OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites. After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.
Interventions
RADIATIONRadiation Therapy
Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans. * Have cancer not originating in central nervous system (CNS) * Karnofsky score of at least 60 * Given written consent * At least 18 years of age
Exclusion criteria
* Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial. * Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status | Up to 5 years | Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Up to 5 years | Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident. |
| Time to Neurological Death | From time of enrollment up to 5 years | Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death. |
| Time to Systemic Death | From time of enrollment up to 5 years | Descriptive analysis will be conducted using Kaplan-Meier survival analysis |
| Karnofsky Decay Time | From time of enrollment up to 5 years | Time from enrollment to the date the patient's Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause. |
Countries
United States
Participant flow
Recruitment details
Patient recruitment period was June 2007 to March 2010
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Conformal Stereotactic Radiation Therapy) Patients undergo conformal stereotatic radiation
Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Treatment (Conformal Stereotactic Radiation Therapy) |
|---|---|
| Age, Customized ≤60 | 20 patients |
| Age, Customized >60 | 19 patients |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Extracranial metastases Absent | 19 patients |
| Extracranial metastases Present | 20 patients |
| Number of brain metastases 1 | 25 patients with brain metastases |
| Number of brain metastases 2 | 4 patients with brain metastases |
| Number of brain metastases 3 | 8 patients with brain metastases |
| Number of brain metastases ≥4 | 2 patients with brain metastases |
| Region of Enrollment United States | 39 patients |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status
Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Conformal Stereotactic Radiation Therapy) | Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status | 5 patients |
Secondary
Karnofsky Decay Time
Time from enrollment to the date the patient's Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause.
Time frame: From time of enrollment up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Conformal Stereotactic Radiation Therapy) | Karnofsky Decay Time | 14 months |
Secondary
Progression-free Survival (PFS)
Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident.
Time frame: Up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Conformal Stereotactic Radiation Therapy) | Progression-free Survival (PFS) | 11 months |
Secondary
Time to Neurological Death
Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death.
Time frame: From time of enrollment up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Conformal Stereotactic Radiation Therapy) | Time to Neurological Death | 13 months |
Secondary
Time to Systemic Death
Descriptive analysis will be conducted using Kaplan-Meier survival analysis
Time frame: From time of enrollment up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Conformal Stereotactic Radiation Therapy) | Time to Systemic Death | 16 months |