Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery
conventional surgery
+ radiation therapy
Enfermedades del Cerebro+8
+ Enfermedades del Sistema Nervioso Central
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation. Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases. Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol. OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests. Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer. Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit. Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above. PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 61 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
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
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesAbrir Jonsson Comprehensive Cancer Center, UCLA en Google Maps