Fractionated Stereotactic Radiosurgery for Large Brain Metastases

N/ACompletedNCT02054689

Steven Burton20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Large Brain Mets

Interventions

Fractionated Stereotactic RadiosurgeryRADIATION

SRS SBRT CyberKnife Trilogy True Beam Radiosurgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC Shadyside Radiation Oncology

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: Up to 24 months post completion of treatment

Secondary Outcomes

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).

Time frame: 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.

Data from ClinicalTrials.gov

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