Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

Phase 2

Terminated

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Metastatic Cancer
• Interventions: Behavioral: MMSE; Behavioral: QOL via FACT-Br; Procedure: MRI; Radiation: Post-operative SRS

• Registration Number: NCT00814463
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-12-23
• Study First Submitted QC: 2008-12-23
• Study First Posted: 2008-12-24
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2013-01-23
• Results First Submitted QC: 2013-05-03
• Results First Posted: 2013-05-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-operative SRS	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.
Post-operative SRS	MRI	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.
Post-operative SRS	QOL via FACT-Br	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.
Post-operative SRS	MMSE	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.

Primary Outcome Measures

Name	Time	Method
Recurrence Rate at the Surgical Site as Measured by MRI	12 months	The number of months for local recurrence via MRI

Secondary Outcome Measures

Name	Time	Method
Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam	Every 3 months for 12 months.
Quality of Life as Measured by the FACT-Br Subscales	Every 3 months for 12 months
Overall Survival	12 months
Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery	12 months
Rate of New Brain Metastases Outside of the Adjuvant SRS Site	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
Rate of Death Due to Neurologic Causes	12 months

Trial Locations

Locations (1)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States