Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00814463
• Other study ID #: Pro00004373
• Secondary ID: DUMC-PRO00004373
• Status: Terminated
• Phase: Phase 2
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Behavioral:
• MMSE
Neurocognitive function via MMSE done every 3 months for length of study.
• QOL via FACT-Br
Quality of Life via FACT-BR every 3 months for length of study.

Procedure:
• MRI
MRI done every 3 months for the length of the study.

Radiation:
• Post-operative SRS
Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Rate at the Surgical Site as Measured by MRI	The number of months for local recurrence via MRI	12 months
Secondary	Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery		12 months
Secondary	Rate of New Brain Metastases Outside of the Adjuvant SRS Site		12 months
Secondary	Quality of Life as Measured by the FACT-Br Subscales		Every 3 months for 12 months
Secondary	Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam		Every 3 months for 12 months.
Secondary	Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)		12 months
Secondary	Rate of Death Due to Neurologic Causes		12 months
Secondary	Overall Survival		12 months