Clinical trial NCT02054689: Fractionated Stereotactic Radiosurgery for Large Brain Metastases
Official title: PHASE I STUDY OF FRACTIONATED STEREOTACTIC RADIOSURGERY FOR LARGE BRAIN METASTASES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Large Brain Mets
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Patients Experiencing DLT
timeFrame: Up to 3 years
measure: Maximum Tolerated Dose (MTD)
timeFrame: Up to 24 months post completion of treatment
Secondary outcomes:
measure: Best Response
timeFrame: Up to 24 months after completion of treatment
measure: Local Control of Disease
timeFrame: Up to 24 months after completion of treatment
measure: Regional Intracranial Failure
timeFrame: Up to 24 months after completion of treatment
measure: Functional Assessment of Cancer Therapy - Brain (FACT-Br)
timeFrame: 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
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside Radiation Oncology
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steve Burton, MD
role: PRINCIPAL_INVESTIGATOR
References: