Dose Escalation for Larger Brain Metastases: Phase I/II Study
stereotactic radiosurgery
+ quality-of-life assessment
+ cognitive assessment
Enfermedades del Cerebro+4
+ Enfermedades del Sistema Nervioso Central
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 2 de julio de 2013
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 33 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, United StatesAbrir Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center en Google Maps