Fractionated Stereotactic Radiosurgery for Large Brain Metastases

Not Applicable

Completed

Conditions: Large Brain Mets

Registration Number: NCT02054689

Lead Sponsor: Steven Burton

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Patients Experiencing DLT	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)	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).

Secondary Outcome Measures

Name	Time	Method
Best Response	Up to 24 months after completion of treatment	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).
Local Control of Disease	Up to 24 months after completion of treatment	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.
Regional Intracranial Failure	Up to 24 months after completion of treatment	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.
Functional Assessment of Cancer Therapy - Brain (FACT-Br)	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	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.

Trial Locations

Locations (1): UPMC Shadyside Radiation Oncology
🇺🇸
Pittsburgh, Pennsylvania, United States
UPMC Shadyside Radiation Oncology
🇺🇸Pittsburgh, Pennsylvania, United States