Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression
SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression.
PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression.
- To determine the feasibility of conducting this study in the United Kingdom.
OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease [spinal metastases only vs spinal and non-bony metastases]). Patients are randomized to 1 of 2 treatment arms.
- Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
- Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Manchester, Reino Unido, M20 6UX
- Christie Hospital
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England
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Bristol, England, Reino Unido, BS2 8ED
- Bristol Haematology and Oncology Centre
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Northwood, England, Reino Unido, HA6 2RN
- Cancer Research UK and University College London Cancer Trials Centre
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Wales
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Rhyl, Denbighshire, Wales, Reino Unido, LL 18 5UJ
- Glan Clwyd Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant disease
Proven diagnosis of metastatic spinal cord compression on MRI or CT scan
- Single site of compression OR multiple sites that can be treated within a single radiation treatment field
- No patient for whom surgery or chemotherapy treatment is more appropriate
- No multiple myeloma as primary cancer
PATIENT CHARACTERISTICS:
- Life expectancy > 1 month
- Not pregnant
- Willing and able to complete assessment forms
- Able to give informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Arm I (multi-fraction radiotherapy)
Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
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Patients undergo external beam radiotherapy
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Experimental: Arm II (single-fraction radiotherapy)
Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
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Patients undergo external beam radiotherapy
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Patient accrual per center over a 12-month period
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Medidas de resultado secundarias
Medida de resultado |
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Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
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Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
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Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
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Quality of life as measured by the EORTC QLQ-C30 questionnaire at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
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Further treatment
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Overall survival at 3, 6, and 12 months
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Total number of days spent in hospital
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Preferred place of care
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Number of patients eligible but not randomized and reasons for non-randomization
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000599886
- CRUK-UCL-BRD-07-010
- CRUK-SCORAD
- ISRCTN97555949
- EU-20863
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