Large Brain MetsNCT02054689
Fractionated Stereotactic Radiosurgery for Large Brain Metastases
A study testing Fractionated Stereotactic Radiosurgery in people with Large Brain Mets, run by Steven Burton at 1 site in United States.
Trial summary
This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Brain Mets
- What is being tested?
- Fractionated Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2013to 9 Mar 2023
- 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
- Male or female patients ≥ 18 years of age
- A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
- The target lesion(s) can be accurately measured in at least one dimension according to RECIST
- No prior radiotherapy to the brain
- Previous or concurrent systemic or targeted chemotherapy is allowed
- Patients must have an extra-cranial primary tumor diagnosis
Show all 11Show fewer
- Patients will have no more than 3 distinct lesions within the brain. At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery
- The additional lesions will each be treated with single fraction stereotactic radiosurgery
- Patient may be on steroids or anti-epileptics
- 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
- Patients do not need a histologically proven diagnosis of brain mets
Who cannot join
- Symptomatic patients in need of surgery to the "target" lesion
- Four or more newly-diagnosed lesions
- Prior surgical resection of targeted tumor
- Prior WBRT
- Primary brain tumor
- Pregnant or breast-feeding patients
- Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, 15232
About this study
Official title: PHASE I STUDY OF FRACTIONATED STEREOTACTIC RADIOSURGERY FOR LARGE BRAIN METASTASES
This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document. This clinical trial is for people who have had no prior whole brain radiation.
- Conditions
- Large Brain Mets
- Being tested
- Fractionated Stereotactic Radiosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Stereotactic RadiosurgeryRadiation
Also called SRS, SBRT, CyberKnife, Trilogy
SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| Fractionated Stereotactic Radiosurgery | Other | 24 to 36 Gy in 3 fractions (8-12 Gy/fx). Receives: Radiation: Fractionated Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Experiencing DLT
The number of patients experiencing DLT, defined as the maximum amount of Gy fractionated stereotactic radiosurgery (FSRS) delivered without significant toxicity.
Measured: Up to 3 years
Maximum Tolerated Dose (MTD)
The MTD was determined following a Time-to-Event Continual Reassessment Model which models toxicity as a function of dose. Treatment was given in 3 fractions (8-12 Gy/fx).
Measured: Up to 24 months post completion of treatment
Secondary outcomes (4)
Best Response
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) in the target lesion, or Progressive Disease (PD) per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Measured: Up to 24 months after completion of treatment
Local Control of Disease
Percentage of patients with local control, defined as stable disease (SD), partial response (PR), or complete response (CR) in the target lesion, per RECIST v1.1. Complete Response (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm., Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Measured: Up to 24 months after completion of treatment
Regional Intracranial Failure
Percentage of patients who develop new lesions outside the target volume. Patients without follow-up scans are excluded as it is not known if they developed lesions outside the target volume.
Measured: Up to 24 months after completion of treatment
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Functional Assessment of Cancer Therapy - Brain (FACT-Br) is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. Scores range from 0-108, with higher scores indicating better Quality of Life.
Measured: Prior to treatment; 30 days post treatment; 8 -12 weeks, 22-28 weeks, 30-42 weeks, 45-60 weeks, 64-74 weeks, 80-84 weeks, 90-96 weeks,100-112 weeks, 120-124 weeks, 130-140 weeks, 145-155 weeks, and 160-170 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study start16 Jul 2013
- Primary completion20 Nov 2017
- Study completion9 Mar 2023
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 Large Brain MetsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Burton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven Burton, University of Pittsburgh
- Investigators
- Steve Burton, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054689
- Sponsor's protocol ID
- HCC 11-091
- Status last verified
- May 2025
- First submitted
- 30 Jan 2014
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE I STUDY OF FRACTIONATED STEREOTACTIC RADIOSURGERY FOR LARGE BRAIN METASTASES
- ClinicalTrials.gov ID
- NCT02054689
- Acronym / sponsor ID
- HCC 11-091
- Conditions
- Large Brain Mets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Steven BurtonUniversity, hospital or other
- Study start
- 16 Jul 2013 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Posted 28 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document. This clinical trial is for people who have had no prior whole brain radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractionated Stereotactic Radiosurgery | Other | Radiation: Fractionated Stereotactic Radiosurgery24 to 36 Gy in 3 fractions (8-12 Gy/fx). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients ≥ 18 years of age
- A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
- The target lesion(s) can be accurately measured in at least one dimension according to RECIST
- No prior radiotherapy to the brain
- Previous or concurrent systemic or targeted chemotherapy is allowed
Key exclusion criteria (7 listed)
- Symptomatic patients in need of surgery to the "target" lesion
- Four or more newly-diagnosed lesions
- Prior surgical resection of targeted tumor
- Prior WBRT
- Primary brain tumor
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 RadiosurgeryAlso: SRS, SBRT, CyberKnife, TrilogySRS SBRT CyberKnife Trilogy True Beam Radiosurgery | Radiation | Fractionated Stereotactic Radiosurgery |
Primary outcome
Number of Patients Experiencing DLT
Time frame: Up to 3 years
The number of patients experiencing DLT, defined as the maximum amount of Gy fractionated stereotactic radiosurgery (FSRS) delivered without significant toxicity.
Maximum Tolerated Dose (MTD)
Time frame: Up to 24 months post completion of treatment
The MTD was determined following a Time-to-Event Continual Reassessment Model which models toxicity as a function of dose. Treatment was given in 3 fractions (8-12 Gy/fx).
4 secondary outcomes
Best Response
Time frame: Up to 24 months after completion of treatment
Local Control of Disease
Time frame: Up to 24 months after completion of treatment
Regional Intracranial Failure
Time frame: Up to 24 months after completion of treatment
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Time frame: Prior to treatment; 30 days post treatment; 8 -12 weeks, 22-28 weeks, 30-42 weeks, 45-60 weeks, 64-74 weeks, 80-84 weeks, 90-96 weeks,100-112 weeks, 120-124 weeks, 130-140 weeks, 145-155 weeks, and 160-170 weeks post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Steve Burton, MD principal investigator
University of Pittsburgh
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 in people with Large Brain Mets, run by Steven Burton 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 11 inclusion and 7 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 28 May 2025. 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 28 May 2025). 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 Experiencing DLT (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 28 May 2025.