N/A
N=20
Fractionated Stereotactic Radiosurgery for Large Brain Metastases
Large Brain Mets
Bottom Line
View on ClinicalTrials.gov: NCT02054689 ↗Enrolled (actual)
20
Serious AEs
4.8%
Results posted
May 2025
Primary outcome: Primary: Number of Patients Experiencing DLT — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fractionated Stereotactic Radiosurgery (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Steven Burton
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Experiencing DLT |
0; 0; 0; 0; 0 | — |
| PRIMARY Maximum Tolerated Dose (MTD) |
36 | — |
| SECONDARY Best Response |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Local Control of Disease |
25; 50; 66.7; 0; 55.6; 75 | — |
| SECONDARY Regional Intracranial Failure |
25; 100; 66.7; 0; 22.2; 25 | — |
| SECONDARY Functional Assessment of Cancer Therapy - Brain (FACT-Br) |
76; 83; 76; 59; 77; 82 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02054689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.