A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain
Colección de datos
Enfermedades Urogenitales+6
+ Enfermedades Genitales
+ Enfermedades Genitales Masculinas
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de abril de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Compare pain response at 4 and 12 weeks post-treatment in patients with localized metastatic bone pain treated with single-dose ibandronate vs single-dose local radiotherapy . Secondary * Compare the quality of life of patients treated with these regimens. * Correlate urinary markers of osteoclast activity (pyridinoline and deoxypyridinoline) with the clinical outcome of patients treated with these regimens. OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are stratified according to primary tumor type and participating center. Patients are randomized into 1 of 2 treatment arms. * Arm I: Patients receive a single dose of local radiotherapy to the site of pain (8Gy/1f). * Arm II: Patients receive a single dose of ibandronate IV over 15 minutes. Patients who do not achieve a partial or complete response at 4 weeks crossover to the alternate arm. Quality of life is assessed at baseline and then at 4 and 12 weeks. Pain is assessed at baseline, at 4, 8, and 12 weeks, and then at 6 months. Patients are followed at 4, 8, and 12 weeks and then at 6 and 12 months. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 470 patients (235 per treatment arm) will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 580 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 or cytologically confirmed primary prostate cancer OR sclerotic bone metastases (for patients with serum prostate-specific antigen \> 100 ng/mL) * Radiologically confirmed bone metastases by plain x-ray, isotope scan, CT scan, or MRI * Clinical diagnosis of metastatic bone pain for which radiotherapy is indicated * Single localized metastatic bone pain AND receiving optimal analgesics and adjuvant drugs, including non-steroidal anti-inflammatory drugs, unless contraindicated * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Over 18 Sex * Male Menopausal status * Not specified Performance status * Not specified Life expectancy * At least 3 months Hematopoietic * Not specified Hepatic * Not specified Renal * Creatinine ≤ 3.0 mg/dL * No hypercalcemia (corrected calcium \> 10.8 mg/dL) * No hypocalcemia (corrected calcium \< 8.2 mg/dL) Other * No known hypersensitivity to ibandronate or other bisphosphonates * No history of aspirin-sensitive asthma * Able to comply with pain chart and quality of life assessments PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior change in systemic chemotherapy * No prior high-dose chemotherapy (dose intensity \> 3 times standard dose) Endocrine therapy * More than 4 weeks since prior change in hormonal therapy Radiotherapy * See Disease Characteristics * No prior external beam radiotherapy to index site * No prior systemic radioisotope therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) Surgery * Not specified Other * More than 6 months since prior bisphosphonate treatment * More than 4 weeks since prior aminoglycoside antibiotics * More than 30 days since prior investigational drugs
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 52 ubicaciones
North Devon District Hospital
Barnstaple, United KingdomBasingstoke and North Hampshire NHS Foundation Trust
Basingstoke, United KingdomRoyal United Hospital
Bath, United Kingdom