Back to resultsPre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
Primary Purpose
Malignant Neoplasm Brain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Neoplasm Brain
Eligibility Criteria
Inclusion Criteria:
- Life expectancy of at least 12 weeks
- Karnofsky performance status of at least 50
- No contraindications to MRI scanning with intravenous contrast.
- MRI scan consistent with brain metastasis as per radiology report.
- Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension.
- Patients must have an extra-cranial primary tumor diagnosis.
- Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain.
- Additional lesions will each be treated with stereotactic radiosurgery.
- Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection
- Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
Exclusion Criteria:
- Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus.
- Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus.
- More than four additional diagnosed brain metastases.
- Contraindication to general anesthesia.
- Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS.
- Primary brain tumor.
- Contraindication to MRI scans or intravenous contrast.
- Pregnant and breast-feeding females.
Sites / Locations
- UPMC Shadyside Radiation Oncology Department
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stereotactic Radiosurgery
Arm Description
Subjects will receive stereotactic radiosurgery prior to resection
Outcomes
Primary Outcome Measures
Local Control Rate (LCR) at 6 months
Tumor volume as measured at a later date and compared to the tumor volume at the start of radiotherapy. The size of a tumor measured by the amount of space taken up by the tumor (percentage of brain occupied by tumor).
Local Control Rate (LCR) at 12 months
Tumor volume as measured at a later date and compared to the tumor volume at the start of radiotherapy. The size of a tumor measured by the amount of space taken up by the tumor (percentage of brain occupied by tumor).
Local Control Rate (LCR) at 24 months
Tumor volume as measured at a later date and compared to the tumor volume at the start of radiotherapy. The size of a tumor measured by the amount of space taken up by the tumor (percentage of brain occupied by tumor).
Secondary Outcome Measures
6-month Overall Survival (OS)
The percentage of patients alive at 6 months after the beginning of treatment.
12-month Overall Survival (OS)
The percentage of patients alive at 12 months after the beginning of treatment.
24-month Overall Survival (OS)
The percentage of patients alive at 24 months after the beginning of treatment.
Distant Intracranial Failure
The probability of new brain metastases identified via magnetic resonance imaging.
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a quality of life (QOL) assessment tool used in patients with primary brain tumors. Questionnaires include the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients and the FACT-Brain (FACT-Br) which assesses brain-tumor related QOL issues. There are 50 items covering the following domains of QOL: physical well-being, social/family well-being, emotional well-being, functional well-being, and disease specific concerns. Patients are asked to indicate the presence/severity of certain issues/symptoms on a scale of 0 - 4 (a 5-point Likert Scale). High scores indicate better quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02514915
Brief Title
Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
Official Title
Phase II Study Determining the Efficacy of Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
July 22, 2021 (Actual)
Study Completion Date
July 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher Wilke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.
Detailed Description
Patients who have a brain metastasis surgically resected have very high local rates of disease relapse, and so the standard of care is to give either whole brain irradiation or stereotactic radiosurgery to the resection cavity in order to prevent disease recurrence. Stereotactic radiosurgery generally offers a more favorable side effect profile than whole brain irradiation, but targeting a surgical resection bed can be a challenge, as post surgical changes make it more difficult to distinguish residual tumor from scar, and much of the dose ends up being focused on the center of the resection cavity, where there are no substantial tumor cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm Brain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic Radiosurgery
Arm Type
Other
Arm Description
Subjects will receive stereotactic radiosurgery prior to resection
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiosurgery
Intervention Description
Radiation therapy
Primary Outcome Measure Information:
Title
Local Control Rate (LCR) at 6 months
Description
Tumor volume as measured at a later date and compared to the tumor volume at the start of radiotherapy. The size of a tumor measured by the amount of space taken up by the tumor (percentage of brain occupied by tumor).
Time Frame
At 6 months
Title
Local Control Rate (LCR) at 12 months
Description
Tumor volume as measured at a later date and compared to the tumor volume at the start of radiotherapy. The size of a tumor measured by the amount of space taken up by the tumor (percentage of brain occupied by tumor).
Time Frame
At 12 months
Title
Local Control Rate (LCR) at 24 months
Description
Tumor volume as measured at a later date and compared to the tumor volume at the start of radiotherapy. The size of a tumor measured by the amount of space taken up by the tumor (percentage of brain occupied by tumor).
Time Frame
At 24 months
Secondary Outcome Measure Information:
Title
6-month Overall Survival (OS)
Description
The percentage of patients alive at 6 months after the beginning of treatment.
Time Frame
At 6 months
Title
12-month Overall Survival (OS)
Description
The percentage of patients alive at 12 months after the beginning of treatment.
Time Frame
At 12 months
Title
24-month Overall Survival (OS)
Description
The percentage of patients alive at 24 months after the beginning of treatment.
Time Frame
At 24 months
Title
Distant Intracranial Failure
Description
The probability of new brain metastases identified via magnetic resonance imaging.
Time Frame
Up to 3 years
Title
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)
Description
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a quality of life (QOL) assessment tool used in patients with primary brain tumors. Questionnaires include the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients and the FACT-Brain (FACT-Br) which assesses brain-tumor related QOL issues. There are 50 items covering the following domains of QOL: physical well-being, social/family well-being, emotional well-being, functional well-being, and disease specific concerns. Patients are asked to indicate the presence/severity of certain issues/symptoms on a scale of 0 - 4 (a 5-point Likert Scale). High scores indicate better quality of life.
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Life expectancy of at least 12 weeks
Karnofsky performance status of at least 50
No contraindications to MRI scanning with intravenous contrast.
MRI scan consistent with brain metastasis as per radiology report.
Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension.
Patients must have an extra-cranial primary tumor diagnosis.
Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain.
Additional lesions will each be treated with stereotactic radiosurgery.
Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection
Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
Exclusion Criteria:
Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus.
Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus.
More than four additional diagnosed brain metastases.
Contraindication to general anesthesia.
Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS.
Primary brain tumor.
Contraindication to MRI scans or intravenous contrast.
Pregnant and breast-feeding females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher A Wilke, MD, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Shadyside Radiation Oncology Department
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
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