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Stereotactic Radiosurgery After Surgery 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
MMSE
QOL via FACT-Br
MRI
Post-operative SRS
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

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.

Sites / Locations

  • Duke Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Post-operative SRS

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Rate of New Brain Metastases Outside of the Adjuvant SRS Site
Quality of Life as Measured by the FACT-Br Subscales
Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam
Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)
Rate of Death Due to Neurologic Causes
Overall Survival

Full Information

First Posted
December 23, 2008
Last Updated
February 1, 2019
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00814463
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Early analysis indicated SRS not as beneficial post-op as pre-op
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (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 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.

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
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-operative SRS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MMSE
Other Intervention Name(s)
Mini-Mental Status Exam
Intervention Description
Neurocognitive function via MMSE done every 3 months for length of study.
Intervention Type
Behavioral
Intervention Name(s)
QOL via FACT-Br
Other Intervention Name(s)
Quality of Life, Functional Assessment of Cancer Therapy - Brain
Intervention Description
Quality of Life via FACT-BR every 3 months for length of study.
Intervention Type
Procedure
Intervention Name(s)
MRI
Other Intervention Name(s)
Magnetic Resonance Imagine
Intervention Description
MRI done every 3 months for the length of the study.
Intervention Type
Radiation
Intervention Name(s)
Post-operative SRS
Other Intervention Name(s)
SRS
Intervention Description
Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
Primary Outcome Measure Information:
Title
Recurrence Rate at the Surgical Site as Measured by MRI
Description
The number of months for local recurrence via MRI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Time Frame
12 months
Title
Rate of New Brain Metastases Outside of the Adjuvant SRS Site
Time Frame
12 months
Title
Quality of Life as Measured by the FACT-Br Subscales
Time Frame
Every 3 months for 12 months
Title
Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam
Time Frame
Every 3 months for 12 months.
Title
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
Title
Rate of Death Due to Neurologic Causes
Time Frame
12 months
Title
Overall Survival
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years of age. 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. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2. Life expectancy of at least 3 months. Exclusion Criteria: Radiographic or cytologic evidence of leptomeningeal disease. Patient with incomplete or partial resection. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma). Patients with a resection cavity > 4 cm in maximal extent in any plane on contrasted MRI scan. Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus. Pregnant or need to breast feed during the study period. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness. Brain surgery other than for resection of metastasis. Previous brain radiotherapy. Contraindication to SRS, WBRT, or MRI.
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 Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

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