Metastatic CancerPhase 2NCT00811655
Stereotactic Radiosurgery in Treating Patients With Brain Metastases
A Phase 2 study testing therapeutic conventional surgery and stereotactic radiosurgery in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Duke University at 1 site in United States.
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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- therapeutic conventional surgery and stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.
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.
Read the 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.
- Being tested
- therapeutic conventional surgery, stereotactic radiosurgery
- Keywords
- tumors metastatic to brain, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic conventional surgeryProcedure or surgery
Surgery of a single brain metastasis.
stereotactic radiosurgeryRadiation
Pre-operative single fraction SRS
| Study group | Role | What they receive |
|---|---|---|
| Pre-Operative SRS | Experimental | SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin. Receives: Procedure: therapeutic conventional surgery; Radiation: stereotactic radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 12 months after SRS
Secondary outcomes (8)
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
Measured: Within 24 months post-SRS
Volume of Adjacent Normal Brain Parenchyma Irradiated
Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).
Measured: At time of 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.
Measured: Within 24 months post-SRS
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.
Measured: Administered at baseline and every 3 months post-SRS
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.
Measured: Administered at baseline and every 3 months post-SRS
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.
Measured: 24 months post-SRS
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.
Measured: Within 24 months post-SRS
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.
Measured: 24 months after SRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John H. Sampson, MD, PhD, Principal investigator, Duke UniversityHamidreza Aliabadi, MD, Principal investigator, Duke UniversityJohn P. Kirkpatrick, MD, Principal investigator, Duke UniversityJames E. Herndon, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811655
- Sponsor's protocol ID
- Pro00006870
- Other IDs
- P30CA014236, DUMC-PRO00006870, CDR0000630230
- Status last verified
- Oct 2013
- First submitted
- 18 Dec 2008
- Last updated
- 25 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.
- ClinicalTrials.gov ID
- NCT00811655
- Acronym / sponsor ID
- Pro00006870
- Keywords
- tumors metastatic to brain, unspecified adult solid tumor, protocol specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Posted 25 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-Operative SRS | Experimental | Procedure: therapeutic conventional surgery, Radiation: stereotactic radiosurgerySRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic conventional surgerySurgery of a single brain metastasis. | Procedure or surgery | Pre-Operative SRS |
| stereotactic radiosurgeryPre-operative single fraction SRS | Radiation | Pre-Operative SRS |
Primary outcome
Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)
Time frame: Within 12 months after 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).
8 secondary outcomes
Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Time frame: Within 24 months post-SRS
Volume of Adjacent Normal Brain Parenchyma Irradiated
Time frame: At time of SRS
Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site
Time frame: Within 24 months post-SRS
Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Time frame: Administered at baseline and every 3 months post-SRS
Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)
Time frame: Administered at baseline and every 3 months post-SRS
Clinical Significance of Locally Recurrent Brain Metastases
Time frame: 24 months post-SRS
Number of Patients Who Died Due to Neurological Causes
Time frame: Within 24 months post-SRS
Overall Survival (OS)
Time frame: 24 months after SRS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John H. Sampson, MD, PhD principal investigator
Duke University
Hamidreza Aliabadi, MD principal investigator
Duke University
John P. Kirkpatrick, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing therapeutic conventional surgery and stereotactic radiosurgery in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS) (time frame: Within 12 months after SRS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.