Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
tumors metastatic to brain, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.
Detailed description
OBJECTIVES: Primary * To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT). Secondary * To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant SRS alone. * To estimate the rate of new brain metastases outside of the adjuvant SRS site. * To estimate patient quality of life after adjuvant SRS alone. * To assess the effect of surgical intervention and SRS on the preservation of neurocognitive functioning in these patients. * To determine the clinical significance (if any) of locally recurrent brain metastases at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) in these patients. * To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease. * To estimate the overall survival of these patients. OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes. Quality of life and neurocognitive function are assessed periodically. After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Interventions
BEHAVIORALMMSE
Neurocognitive function via MMSE done every 3 months for length of study.
BEHAVIORALQOL via FACT-Br
Quality of Life via FACT-BR every 3 months for length of study.
PROCEDUREMRI
MRI done every 3 months for the length of the study.
RADIATIONPost-operative SRS
Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
Sponsors
National Cancer Institute (NCI)
Duke University
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
1. Age \>18 years of age. 2. Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS. 3. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2. 4. Life expectancy of at least 3 months.
Exclusion criteria
1. Radiographic or cytologic evidence of leptomeningeal disease. 2. Patient with incomplete or partial resection. 3. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma). 4. Patients with a resection cavity \> 4 cm in maximal extent in any plane on contrasted MRI scan. 5. Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus. 6. Pregnant or need to breast feed during the study period. 7. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness. 8. Brain surgery other than for resection of metastasis. 9. Previous brain radiotherapy. 10. Contraindication to SRS, WBRT, or MRI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate at the Surgical Site as Measured by MRI | 12 months | The number of months for local recurrence via MRI |
Secondary
| Measure | Time frame |
|---|---|
| Rate of New Brain Metastases Outside of the Adjuvant SRS Site | 12 months |
| Quality of Life as Measured by the FACT-Br Subscales | Every 3 months for 12 months |
| Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam | Every 3 months for 12 months. |
| Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery | 12 months |
| Rate of Death Due to Neurologic Causes | 12 months |
| Overall Survival | 12 months |
| Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms) | 12 months |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the Duke Comprehensive Cancer Center from 6/12/2008 - 6/5/2009.
Participants by arm
| Arm | Count |
|---|---|
| Post-operative SRS All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.
Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
MMSE : Neurocognitive function via MMSE done every 3 months for length of study.
MRI : MRI done every 3 months for the length of the study. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Post-operative SRS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 67 years |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Recurrence Rate at the Surgical Site as Measured by MRI
The number of months for local recurrence via MRI
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post-operative SRS | Recurrence Rate at the Surgical Site as Measured by MRI | 3.5 Months |
Secondary
Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)
Time frame: 12 months
Population: Data not collected due to subject withdrawal.
Secondary
Overall Survival
Time frame: 12 months
Population: Data not collected due to subject withdrawal.
Secondary
Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam
Time frame: Every 3 months for 12 months.
Population: Data not collected due to subject withdrawal.
Secondary
Quality of Life as Measured by the FACT-Br Subscales
Time frame: Every 3 months for 12 months
Population: Data not collected due to subject withdrawal.
Secondary
Rate of Death Due to Neurologic Causes
Time frame: 12 months
Population: Data not collected due to subject withdrawal.
Secondary
Rate of New Brain Metastases Outside of the Adjuvant SRS Site
Time frame: 12 months
Population: Data not collected due to subject withdrawal.
Secondary
Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Post-operative SRS | Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery | 1 Participants |