Dose Escalation for Larger Brain Metastases: Phase I/II Study
stereotactic radiosurgery
+ quality-of-life assessment
+ cognitive assessment
Brain Diseases+5
+ Central Nervous System Diseases
+ Neoplasms
Treatment Study
Summary
Study start date: July 2, 2013
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVES: I. To determine the incidence of acute and long-term toxicities with increasing dose of stereotactic radiosurgery (SRS). (Phase I) II. To determine if local control may be improved with increasing doses of SRS. (Phase II) SECONDARY OBJECTIVES: I. To determine the risk of acute and long-term toxicity with increasing dose of SRS. (Phase II) II. To determine if there is increased neurocognitive toxicity with increased dose of SRS. III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine if quality of life is affected more by tumor recurrence versus radiation necrosis. This includes assessment of progression free survival, overall survival, local failure, and number of patients who receive bevacizumab, laser interstitial thermal therapy, or surgery for presumed radiation necrosis. OUTLINE: This is a phase I dose-escalation study followed by a phase II study. Patients undergo SRS guided by computer tomography (CT) and magnetic resonance imaging (MRI). After completion of treatment, patients are followed up at 1-2, 3, 6, 9, and 12 months, every 3 months for 2 years, and then every 4 months thereafter.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Any patient undergoing SRS for brain metastases Lesions to be treated under this protocol must be > 2 cm, but =< 4.0 cm in diameter Patients may have had prior therapy including: Whole brain radiation therapy (WBRT) > 3 months ago SRS to other brain metastases Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies Patient must be able to provide written informed consent Exclusion Criteria: Patients receiving SRS to resection bed Planned concurrent WBRT Leptomeningeal metastases Small cell lung cancer, lymphoma, and germ cell histologies Inability to participate in study activities due to physical or mental limitations Inability or unwillingness to return for all the required follow-up visits Conformality index 2.0 or less cannot be achieved, or homogeneity index is > 2.0 Unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm Brainstem location is excluded from this study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, United StatesOpen Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center in Google Maps