Clinical trial NCT00814463: Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases
Official title: Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: tumors metastatic to brain
unspecified adult solid tumor, protocol specific
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence Rate at the Surgical Site as Measured by MRI
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
timeFrame: 12 months
measure: Rate of New Brain Metastases Outside of the Adjuvant SRS Site
timeFrame: 12 months
measure: Quality of Life as Measured by the FACT-Br Subscales
timeFrame: Every 3 months for 12 months
measure: Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam
timeFrame: Every 3 months for 12 months.
measure: Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)
timeFrame: 12 months
measure: Rate of Death Due to Neurologic Causes
timeFrame: 12 months
measure: Overall Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John H. Sampson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Hamidreza Aliabadi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: John P. Kirkpatrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: James E. Herndon, PhD
role: PRINCIPAL_INVESTIGATOR
References: