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Stereotactic Radiosurgery in Treating Patients With Brain Metastases

Primary Purpose

Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
therapeutic conventional surgery
stereotactic radiosurgery
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring tumors metastatic to brain, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of brain metastases from an extracranial primary site

    • Tumor ≤ 4 cm in maximal extent in any plane on contrast MRI

  • Scheduled to undergo gross total resection of a single brain metastasis confirmed by histology

    • Up to 4 metastases allowed provided the largest mass is amenable to surgical resection and all non-resected masses are amenable to stereotactic radiosurgery (SRS)

  • RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following:

    • RPA class 1: Karnofsky performance status (KPS) 70-100%; age < 65 years; controlled primary disease; and no extracranial metastatic disease
    • RPA class 2: KPS 70-100%; uncontrolled primary disease; and/or extracranial metastatic disease
  • No lesion located in anatomic regions that are not amenable to SRS, including the brain stem, optic apparatus, or eloquent cortex
  • No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma)
  • No radiographic or cytologic evidence of leptomeningeal disease

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • Not pregnant or nursing
  • Negative pregnancy test

  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Psychiatric illness
  • No contraindication to SRS, whole-brain radiotherapy, or MRI

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior brain surgery other than resection of metastasis
  • No prior brain radiotherapy

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre-Operative SRS

Arm Description

SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.

Outcomes

Primary Outcome Measures

Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)
Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).

Secondary Outcome Measures

Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery
Volume of Adjacent Normal Brain Parenchyma Irradiated
Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).
Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site
Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.
Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.
Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)
Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.
Clinical Significance of Locally Recurrent Brain Metastases
Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.
Number of Patients Who Died Due to Neurological Causes
Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.
Overall Survival (OS)
Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.

Full Information

First Posted
December 18, 2008
Last Updated
October 30, 2013
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00811655
Brief Title
Stereotactic Radiosurgery in Treating Patients With Brain Metastases
Official Title
Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. 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 neoadjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgical resection and whole-brain radiotherapy (WBRT). Secondary To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with neoadjuvant SRS alone. To determine the volume of adjacent normal brain parenchyma irradiated in these patients. To estimate the rate of new brain metastases outside of the neoadjuvant SRS site in these patients. To estimate the quality of life of these patients after neoadjuvant SRS alone. To assess the effect of SRS and surgical intervention on the preservation of neurocognitive functioning in these patients. To determine the clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence in these patients. To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease, in these patients. To estimate the overall survival of these patients. OUTLINE: Patients undergo stereotactic radiosurgery over 30 to 90 minutes. Approximately 2-4 weeks later, patients undergo surgical resection of brain metastasis. Quality of life and neurocognitive function are assessed periodically using the FACT-Br subscales and Mini-Mental State Exam. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
tumors metastatic to brain, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Operative SRS
Arm Type
Experimental
Arm Description
SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Surgery of a single brain metastasis.
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Intervention Description
Pre-operative single fraction SRS
Primary Outcome Measure Information:
Title
Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)
Description
Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).
Time Frame
Within 12 months after SRS
Secondary Outcome Measure Information:
Title
Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Description
Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery
Time Frame
Within 24 months post-SRS
Title
Volume of Adjacent Normal Brain Parenchyma Irradiated
Description
Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).
Time Frame
At time of SRS
Title
Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site
Description
Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.
Time Frame
Within 24 months post-SRS
Title
Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Description
Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.
Time Frame
Administered at baseline and every 3 months post-SRS
Title
Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)
Description
Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.
Time Frame
Administered at baseline and every 3 months post-SRS
Title
Clinical Significance of Locally Recurrent Brain Metastases
Description
Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.
Time Frame
24 months post-SRS
Title
Number of Patients Who Died Due to Neurological Causes
Description
Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.
Time Frame
Within 24 months post-SRS
Title
Overall Survival (OS)
Description
Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Time Frame
24 months after SRS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of brain metastases from an extracranial primary site Tumor ≤ 4 cm in maximal extent in any plane on contrast MRI Scheduled to undergo gross total resection of a single brain metastasis confirmed by histology Up to 4 metastases allowed provided the largest mass is amenable to surgical resection and all non-resected masses are amenable to stereotactic radiosurgery (SRS) RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following: RPA class 1: Karnofsky performance status (KPS) 70-100%; age < 65 years; controlled primary disease; and no extracranial metastatic disease RPA class 2: KPS 70-100%; uncontrolled primary disease; and/or extracranial metastatic disease No lesion located in anatomic regions that are not amenable to SRS, including the brain stem, optic apparatus, or eloquent cortex No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma) No radiographic or cytologic evidence of leptomeningeal disease PATIENT CHARACTERISTICS: See Disease Characteristics Not pregnant or nursing Negative pregnancy test No concurrent uncontrolled illness including, but not limited to, any of the following: Symptomatic congestive heart failure Unstable angina pectoris Psychiatric illness No contraindication to SRS, whole-brain radiotherapy, or MRI PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior brain surgery other than resection of metastasis No prior brain radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John H. Sampson, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hamidreza Aliabadi, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John P. Kirkpatrick, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James E. Herndon, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Stereotactic Radiosurgery in Treating Patients With Brain Metastases

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