Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
pain therapy
+ radiation therapy
+ pain therapy
Enfermedades Urogenitales+16
+ Enfermedades Genitales
+ Enfermedades de la Mama
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de febrero de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Compare the ability of a single fraction of radiation therapy vs multiple fractions to provide complete pain relief in patients with painful bone metastases from breast or prostate cancer. Determine the frequency and duration of pain relief and narcotic relief after these treatments in these patient populations. Compare the effect on quality of life of these two treatments in these patient populations. Compare the incidence of pathologic fracture within the treatment fields after these two treatments in these patient populations. OUTLINE: This is a randomized study. Patients are assigned to 1 of 2 treatment arms. Arm I consists of radiation therapy delivered in 10 fractions over 2 weeks. Arm II consists of a single dose of radiation therapy. Any retreatment does not occur until at least 4 weeks after prior treatment unless there is an increase of 2 points on the pain score. Patients are followed and quality of life is assessed at 2 and 4 weeks, then at 2, 3, 6, 9, and 12 months, every 6 months for the next 3 years, then annually until death. PROJECTED ACCRUAL: This study will accrue 938 patients within 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 949 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
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
DISEASE CHARACTERISTICS: Histologically proven breast or prostate cancer Radiographic evidence of bone metastasis within 8 weeks of study Eligible treatment sites: Weight-bearing sites: Pelvis (excluding pubis) Femur Sacrum and/or sacroiliac joints Tibia Non-weight-bearing sites: Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies Lumbosacral spine Up to 3 consecutive ribs Humerus Fibula Radius with/without ulna Clavicle Scapula Pubis If multiple sites are treated, site is included as weight bearing if any of the sites include the pelvis, sacrum, femur, or tibia Worst pain score of at least 5 on a scale of 10 No skull, feet, or hand metastases No spinal cord or cauda equina compression/effacement in vertebral metastases Multiple sites eligible if they can be included in no greater than 3 treatment sites PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 40-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No impending fracture of the treatment site No hematologic primary malignancies Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: No change in immunotherapy within 30 days Chemotherapy: No change in chemotherapy within 30 days Endocrine therapy: No change in hormonal therapy within 30 days Radiotherapy: No prior radiation therapy to treatment area At least 30 days since systemic radiotherapy (Sr 89) Surgery: No prior palliative surgery to treatment area No planned surgical fixation of the bone
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalCentros 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 253 ubicaciones
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesAbrir University of Alabama at Birmingham Comprehensive Cancer Center en Google MapsHuntsville Hospital System
Huntsville, United StatesComprehensive Cancer Institute of Huntsville
Huntsville, United StatesMBCCOP - Gulf Coast
Mobile, United States