Brain CancerNCT00928226
Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
A study testing Fractionated Stereotactic Radiosurgery (SRS) and Surgical resection in people with Brain Cancer and Neoplasm Metastasis, run by Stanford University at 1 site in United States.
Trial summary
The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery (SRS) to treat brain metastases greater than 4.2 cm³ in size will be determined. This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Neoplasm Metastasis, Cancer of Brain and Nervous System
- What is being tested?
- Fractionated Stereotactic Radiosurgery (SRS) and Surgical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years and older
- Pathologically-proven solid tumor malignancy
- 1 to 4 brain metastases, one of which is 4.2 to 33.5 cm³.
- Prior surgery or SRS is allowed as long as the target metastatic lesion in this study has not previously been treated with SRS.
- Prior cytotoxic systemic therapy must be completed ≥ 5 days prior to radiosurgery. No concurrent cytotoxic systemic therapy along with SRS. Cytotoxic systemic therapy to start ≥ 5 days after the completion of SRS.
- Life expectancy of ≥ 12 weeks.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Previously treated with whole brain irradiation
- Target metastatic lesion previously been treated with SRS.
- > 4 total brain metastases at the time of initial evaluation.
- Pregnant
- Unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery (SRS) to treat brain metastases greater than 4.2 cm³ in size will be determined.
This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects).
Read the detailed description
Brain metastases are the most common intracranial tumors and occur in approximately 25% of patients with cancer. In the US, approximately 170,000 cancer patients a year are diagnosed with brain metastases.
The prognosis of patients with brain metastases is variable and depends on several factors, including performance status, age, control of the primary tumor, and extent of extracranial disease. Historically, patients with brain metastases who receive supportive care only have median survival of 1 to 2 months. However, a subgroup of patients with favorable prognosis who undergo treatment can enjoy an extended life expectancy with median survival of 10 to 16 months. Treatment options for brain metastases include medical management, surgery, and radiation therapy (radiotherapy). Both surgery and radiotherapy have an important role in management of brain metastases, and an optimized treatment plan may include both. It is well-established that surgery followed by conventional whole brain radiation (WBRT) decreases local recurrence and improves median survival compared to WBRT alone. Conventional WBRT is administered as radiotherapy to the whole cranium delivered in 10 to 20 daily treatments.
For this study, radiotherapy will be delivered using stereotactic radiosurgery (SRS) to treat individual metastases. SRS has the advantage of sparing normal brain tissue. In SRS, high energy radiation is precisely directed at the target lesion. Due to the steep fall-off of the radiation dose away from the target, the advantage of relative sparing of the normal brain may be realized. The present study is based on a rationale of treating brain metastases with surgical resection followed by adjuvant SRS to the resection cavity, while deferring conventional WBRT for salvage therapy.
WBRT is associated with a short-term decline in quality of life and long-term deficits in neurocognitive function ("late effects"). Late toxicity of WBRT, such as memory impairment and dementia, is usually irreversible and is likely due to demyelination, vascular damage, and necrosis. Following WBRT, the actuarial rate of neurocognitive toxicity at 2 years can be up to 49%. Recipients of WBRT may demonstrate a > 2 standard deviation decline in their performance at 6 months. Compared to SRS alone, WBRT was reported to be associated with a marked decline in learning and memory function at 4 months (49% vs 23%, in favor of SRS).
To minimize the potential late effects of WBRT, investigators have explored the use of SRS alone, deferring the use of WBRT for salvage treatment if needed. Both retrospective analyses and a prospective randomized trial reported no apparent survival benefit to combining WBRT with SRS compared to SRS alone
Primary Objectives: Determine the maximum tolerated dose (MTD) of stereotactic radiosurgery (SRS).
Secondary Objectives:
- Determine the local control rate as assessed on MRI and clinical exam.
- Determine short- and long-term adverse effects.
- Determine the distant intra-cranial control rate.
- Determine the overall survival rate.
- Assess the patient's health related quality of life.
Treatment Group assignment will be by SRS dose level. SRS will be administered as 3 fractions. Radiation dose is administered as "Greys" (or "Grays"; abbreviated Gy), a unit by which radiation is measured. Treatment Groups are as follows: Group 1 = 24 Gy (administered as 8 Gy x 3) Group 2 = 7 Gy (9 Gy x 3); Group 3 = 30 Gy (10 Gy x 3); Group 4 = 33 Gy (11 Gy x 3).
Within each Treatment Group, analysis may be stratified by tumor size and suitability for surgical resection, as below. For those participants eligible for surgical resection, the procedure will be conducted in advance of the SRS treatment.
- Strata A will be those with tumors 4.2 to 14.1 cm³, and suitable for resection.
- Strata B will be those with tumors 4.2 to 14.1 cm³, but not suitable for resection.
- Strata C will be those with tumors 14.2 to 33.5 cm³, and suitable for resection.
- Strata D will be those with tumors 14.2 to 33.5 cm³, but not suitable for resection.
- Conditions
- Brain Cancer, Neoplasm Metastasis, Cancer of Brain and Nervous System, Metastatic Malignant Neoplasm to Brain
- Being tested
- Fractionated Stereotactic Radiosurgery (SRS), Surgical resection
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Stereotactic Radiosurgery (SRS)Radiation
Also called Cyberknife surgery
Standard of care
Surgical resectionProcedure or surgery
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - 24 Grey SRS | Experimental | 24 Grey administered as 8 Gy x 3 fractions Receives: Radiation: Fractionated Stereotactic Radiosurgery (SRS); Procedure: Surgical resection |
| Arm 2 - 27 Grey SRS | Experimental | 27 Grey administered as 9 Gy x 3 fractions Receives: Radiation: Fractionated Stereotactic Radiosurgery (SRS); Procedure: Surgical resection |
| Arm 3 - 30 Grey SRS | Experimental | 30 Grey administered as 10 Gy x 3 fractions Receives: Radiation: Fractionated Stereotactic Radiosurgery (SRS); Procedure: Surgical resection |
| Arm 4 - 33 Grey SRS | Experimental | 33 Grey administered as 11 Gy x 3 fractions Receives: Radiation: Fractionated Stereotactic Radiosurgery (SRS); Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD)
The maximum-tolerated Dose (MTD) of stereotactic radiosurgery (SRS) was assessed based on the number of dose-limiting toxicities (DLTs). DLT was defined as any treatment-related grade 3, 4, or 5 central nervous system (CNS) radiation morbidity observed within 30 days of radiosurgery. CNS radiation morbidity was further defined as.
- 5 = Death
- 4 = Serious neurologic impairment such as paralysis, coma, or seizures > 3/week
- 3 = Neurologic findings requiring hospitalization
- 2 = Neurologic findings present sufficient to require attendant care
- 1 = Fully functional status (ie, able to work) with minor neurologic findings; no medication needed
- 0 = No Change
The outcome is expressed as number of DLTs experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. Per protocol, the MTD of SRS was defined as either the dose level below that at which 4+ DLTs were experienced by 12 subjects, or the maximum dose administered without MTD.
Measured: 60 days
Secondary outcomes (7)
Local Disease Control
Local disease control (treatment response) was assessed on the basis of tumor size before and 12 months after treatment. Treatment response was based on the following criteria. Tumor area is determined as the product of 2 measurements of lesion diameter.
- Complete response (CR): The tumor is no longer seen within the radiosurgical target volume
- Partial response (PR): Decrease of > 50% in tumor area
- Minor response (MR): Decrease of < 50% in tumor area
- Stable disease (SD): The scan shows no change.
- Progression (P): A > 25% increase in tumor area, or any new lesion within the radiosurgical target volume.
Local control is defined as as any treatment response other than progression. The outcome is as the number of participants that did not progress, by radiotherapy dose cohort and tumor size, a number without dispersion.
Measured: 12 months
Distant Intra-cranial Disease Control
Distant treatment failure (failure to achieve or maintain disease control) is defined as the radiographic appearance of a new or enhancing lesion more than 5 mm from the radiosurgical target volume. The outcome is expressed as the number of participants who have distant treatment failure after radiotherapy dose cohort and tumor size, a number without dispersion.
Measured: 12 months
Adverse Effects Within 30 Days
Short-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring within 30 days of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion.
Measured: 30 days
Adverse Effects More Than 30 Days up to 1 Year
Long-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring more 30 days but within 12 months of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion.
Measured: after 30 days and up to 1 year
Overall Survival (OS)
Overall survival (OS) is assessed as remaining alive 3 years after stereotactic radiosurgery (SRS) therapy. The outcome is expressed as the number of participants alive 3 years after SRS, by radiotherapy dose cohort and tumor size, a number without dispersion.
Measured: 3 years
Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30
Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) survey, a survey of 28 questions with the following responses / numerical values.
- Not at all
- A Little
- Quite a Bit
- Very Much Response range is 28 to 112, normalized to a 100 point scale. Lower values indicate little effect of disease, and higher values indicate greater effect. The outcome is expressed as the median value with full range, by radiotherapy dose cohort and tumor size.
Measured: 6 months
Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20
Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Brain Cancer Module (QLQ-BN20), a survey of 20 questions with the following responses / numerical values.
- Not at all
- A Little
- Quite a Bit
- Very Much Response range is 20 to 80, normalized to a 0 to 100 scale. Lower values indicate little effect of disease, and higher values indicate greater effect. The outcome is expressed as the median value with full range, by radiotherapy dose cohort and tumor size.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startApr 2009
- Primary completion31 Oct 2017
- Study completionDec 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Stanford 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Soltys, Stanford University
- Investigators
- Clara Choi, Principal investigator, Stanford UniversityScott Soltys, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928226
- Sponsor's protocol ID
- IRB-15107
- Other IDs
- SU-04272009-2418, BRN0010
- Status last verified
- Jan 2024
- First submitted
- 23 Jun 2009
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rahimy E, Dudley SA, von Eyben R, Pollom EL, Seiger K, Modlin L, Wynne J, Fujimoto D, Jacobs LR, Chang SD, Gibbs IC, Hancock SL, Adler JR, Li G, Choi CYH, Soltys SG. Phase I/II Dose-Escalation Trial of 3-Fraction Stereotactic Radiosurgery for Resection Cavities From Large Brain Metastases: Health-related Quality of Life Outcomes. Am J Clin Oncol. 2021 Nov 1;44(11):588-595. doi: 10.1097/COC.0000000000000868.
PubMed 34670228
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
- ClinicalTrials.gov ID
- NCT00928226
- Acronym / sponsor ID
- IRB-15107
- Conditions
- Brain Cancer, Neoplasm Metastasis, Cancer of Brain and Nervous System, Metastatic Malignant Neoplasm to Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2009 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery (SRS) to treat brain metastases greater than 4.2 cm³ in size will be determined.
This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects).
Detailed description
Brain metastases are the most common intracranial tumors and occur in approximately 25% of patients with cancer. In the US, approximately 170,000 cancer patients a year are diagnosed with brain metastases.
The prognosis of patients with brain metastases is variable and depends on several factors, including performance status, age, control of the primary tumor, and extent of extracranial disease. Historically, patients with brain metastases who receive supportive care only have median survival of 1 to 2 months. However, a subgroup of patients with favorable prognosis who undergo treatment can enjoy an extended life expectancy with median survival of 10 to 16 months. Treatment options for brain metastases include medical management, surgery, and radiation therapy (radiotherapy). Both surgery and radiotherapy have an important role in management of brain metastases, and an optimized treatment plan may include both. It is well-established that surgery followed by conventional whole brain radiation (WBRT) decreases local recurrence and improves median survival compared to WBRT alone. Conventional WBRT is administered as radiotherapy to the whole cranium delivered in 10 to 20 daily treatments.
For this study, radiotherapy will be delivered using stereotactic radiosurgery (SRS) to treat individual metastases. SRS has the advantage of sparing normal brain tissue. In SRS, high energy radiation is precisely directed at the target lesion. Due to the steep fall-off of the radiation dose away from the target, the advantage of relative sparing of the normal brain may be realized. The present study is based on a rationale of treating brain metastases with surgical resection followed by adjuvant SRS to the resection cavity, while deferring conventional WBRT for salvage therapy.
WBRT is associated with a short-term decline in quality of life and long-term deficits in neurocognitive function ("late effects"). Late toxicity of WBRT, such as memory impairment and dementia, is usually irreversible and is likely due to demyelination, vascular damage, and necrosis. Following WBRT, the actuarial rate of neurocognitive toxicity at 2 years can be up to 49%. Recipients of WBRT may demonstrate a > 2 standard deviation decline in their performance at 6 months. Compared to SRS alone, WBRT was reported to be associated with a marked decline in learning and memory function at 4 months (49% vs 23%, in favor of SRS).
To minimize the potential late effects of WBRT, investigators have explored the use of SRS alone, deferring the use of WBRT for salvage treatment if needed. Both retrospective analyses and a prospective randomized trial reported no apparent survival benefit to combining WBRT with SRS compared to SRS alone
Primary Objectives: Determine the maximum tolerated dose (MTD) of stereotactic radiosurgery (SRS).
Secondary Objectives:
- Determine the local control rate as assessed on MRI and clinical exam.
- Determine short- and long-term adverse effects.
- Determine the distant intra-cranial control rate.
- Determine the overall survival rate.
- Assess the patient's health related quality of life.
Treatment Group assignment will be by SRS dose level. SRS will be administered as 3 fractions. Radiation dose is administered as "Greys" (or "Grays"; abbreviated Gy), a unit by which radiation is measured. Treatment Groups are as follows: Group 1 = 24 Gy (administered as 8 Gy x 3) Group 2 = 7 Gy (9 Gy x 3); Group 3 = 30 Gy (10 Gy x 3); Group 4 = 33 Gy (11 Gy x 3).
Within each Treatment Group, analysis may be stratified by tumor size and suitability for surgical resection, as below. For those participants eligible for surgical resection, the procedure will be conducted in advance of the SRS treatment.
- Strata A will be those with tumors 4.2 to 14.1 cm³, and suitable for resection.
- Strata B will be those with tumors 4.2 to 14.1 cm³, but not suitable for resection.
- Strata C will be those with tumors 14.2 to 33.5 cm³, and suitable for resection.
- Strata D will be those with tumors 14.2 to 33.5 cm³, but not suitable for resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - 24 Grey SRS | Experimental | Radiation: Fractionated Stereotactic Radiosurgery (SRS), Procedure: Surgical resection24 Grey administered as 8 Gy x 3 fractions |
| Arm 2 - 27 Grey SRS | Experimental | Radiation: Fractionated Stereotactic Radiosurgery (SRS), Procedure: Surgical resection27 Grey administered as 9 Gy x 3 fractions |
| Arm 3 - 30 Grey SRS | Experimental | Radiation: Fractionated Stereotactic Radiosurgery (SRS), Procedure: Surgical resection30 Grey administered as 10 Gy x 3 fractions |
| Arm 4 - 33 Grey SRS | Experimental | Radiation: Fractionated Stereotactic Radiosurgery (SRS), Procedure: Surgical resection33 Grey administered as 11 Gy x 3 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years and older
- Pathologically-proven solid tumor malignancy
- 1 to 4 brain metastases, one of which is 4.2 to 33.5 cm³.
- Prior surgery or SRS is allowed as long as the target metastatic lesion in this study has not previously been treated with SRS.
- Prior cytotoxic systemic therapy must be completed ≥ 5 days prior to radiosurgery. No concurrent cytotoxic systemic therapy along with SRS. Cytotoxic systemic therapy to start ≥ 5 days after the completion of SRS.
Key exclusion criteria (5 listed)
- Previously treated with whole brain irradiation
- Target metastatic lesion previously been treated with SRS.
- > 4 total brain metastases at the time of initial evaluation.
- Pregnant
- Unable to give informed consent.
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 |
|---|---|---|
| Fractionated Stereotactic Radiosurgery (SRS)Also: Cyberknife surgeryStandard of care | Radiation | Arm 1 - 24 Grey SRS, Arm 2 - 27 Grey SRS, Arm 3 - 30 Grey SRS, Arm 4 - 33 Grey SRS |
| Surgical resectionStandard of care | Procedure or surgery | Arm 1 - 24 Grey SRS, Arm 2 - 27 Grey SRS, Arm 3 - 30 Grey SRS, Arm 4 - 33 Grey SRS |
Primary outcome
Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD)
Time frame: 60 days
The maximum-tolerated Dose (MTD) of stereotactic radiosurgery (SRS) was assessed based on the number of dose-limiting toxicities (DLTs). DLT was defined as any treatment-related grade 3, 4, or 5 central nervous system (CNS) radiation morbidity observed within 30 days of radiosurgery. CNS radiation morbidity was further defined as. * 5 = Death * 4 = Serious neurologic impairment such as paralysis, coma, or seizures > 3/week * 3 = Neurologic findings requiring hospitalization * 2 = Neurologic findings present sufficient to require attendant care * 1 = Fully functional status (ie, able to work) with minor neurologic findings; no medication needed * 0 = No Change The outcome is expressed as number of DLTs experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. Per protocol, the MTD of SRS was defined as either the dose level below that at which 4+ DLTs were experienced by 12 subjects, or the maximum dose administered without MTD.
7 secondary outcomes
Local Disease Control
Time frame: 12 months
Distant Intra-cranial Disease Control
Time frame: 12 months
Adverse Effects Within 30 Days
Time frame: 30 days
Adverse Effects More Than 30 Days up to 1 Year
Time frame: after 30 days and up to 1 year
Overall Survival (OS)
Time frame: 3 years
Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30
Time frame: 6 months
Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34670228Rahimy E, Dudley SA, von Eyben R, Pollom EL, Seiger K, Modlin L, Wynne J, Fujimoto D, Jacobs LR, Chang SD, Gibbs IC, Hancock SL, Adler JR, Li G, Choi CYH, Soltys SG. Phase I/II Dose-Escalation Trial of 3-Fraction Stereotactic Radiosurgery for Resection Cavities From Large Brain Metastases: Health-related Quality of Life Outcomes. Am J Clin Oncol. 2021 Nov 1;44(11):588-595. doi: 10.1097/COC.0000000000000868.
- Individual participant dataSharing planned: No
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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.
Clara Choi principal investigator
Stanford University
Scott Soltys principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Stereotactic Radiosurgery (SRS) and Surgical resection in people with Brain Cancer and Neoplasm Metastasis, run by Stanford 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?
The sponsor lists 7 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 30 Jan 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). 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?
Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD) (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928226, which also lists 1 linked publication.
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 30 Jan 2024.