Comparing Immobilisation Shells in Cranial Radiotherapy (CORIOLIS)
A Randomised Controlled Trial Comparing the Accuracy and Acceptability of Closed-face and Open-face Thermoplastic Immobilisation Shells in Cranial Radiotherapy
Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent patient movement and improve treatment accuracy. These shells tend to cover the face and have the potential to cause anxiety and distress in patients, particularly if they suffer with claustrophobia or a similar fear. The study will use an 'open-face' shell that does not cover the face and compare this with the investigators' current 'closed-face' shell. The investigators will obtain treatment verification x-ray images to assess the daily set-up errors and compare these between the two shell type, and ask both patients and radiographers of their experiences from using the shells.
Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of radiotherapy delivery and are better accepted by patients and radiographers as compared to closed-face immobilisation shells for cranial radiotherapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients will be randomised into one of two groups, with group A acting as the control group using the investigators' standard 3--point closed--face shell, and group B using the 3--point open--face shell (experimental group). Each procedure is discussed with the patient before commencement. Patients will be positioned into the optimal treatment position and the shell will be fabricated as per manufacturer instructions by pre-treatment radiographers. This is followed by the patient having a planning CT scan of their head while wearing their shell to allows radiographers and doctors to localise and plan the treatment. At the end of this appointment, the patient will be asked to complete the first of three questionnaires regarding their experience of wearing the shell. Radiographers will be asked to complete a questionnaire of their experience of using the shell, and complete timing data for the procedures.
On the first day of treatment, radiographers will discuss the treatment process and side effects of treatment with the patient, and treatment will be delivered under current department protocols using linear accelerators (linacs). During the course of the treatment, radiographers will obtain 5 sets of verification images for the study, and these will be assessed for set-up errors as per current department policy. Where possible, treatment fields will be used to verify patient position to keep radiation doses from verification imaging as low as reasonably practicable (ALARP). Patients will be asked to complete two more questionnaires on their experience, one on their first day and one on their last day of treatment. Radiographers will also complete questionnaires on these days. Timing data will be obtained for all treatment fractions.
The patient's perspective of the planning and treatment processes will be almost identical to that of patients having cranial radiotherapy that are not in the trial. The only differences that will be observed will be the use of an open-face shell (for patients in group B), completion of three questionnaires, and additional verification imaging.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido, SW3 6JJ
- Royal Marsden Hospital NHS Foundation Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients prescribed cranial radiotherapy using virtually simulated parallel opposed fields with:
- 5 or more fractions of virtually simulated cranial radiotherapy
- treatment for Primary Central Nervous System Lymphoma (PCNSL), prophylactic cranial irradiation (PCI), or primary or secondary cerebral or bony lesions
Exclusion Criteria:
- patients unable to give informed consent
- patients requiring conformal or inverse-planned radiotherapy
- patients requiring stereotactic radiotherapy
- patients who have previously had cranial or head and neck radiotherapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Group A: Closed-face shells
Cranial radiotherapy using the control closed-face immobilisation shell.
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As for arm description
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Experimental: Group B: open-face shell
Cranial radiotherapy using the experimental open-face immobilisation shell
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As for arm description
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
Periodo de tiempo: within 2 weeks of completion of treatment
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Assessment of verification imaging to determine individual systematic and random errors.
Individual errors are collated to determine group systematic and random errors for comparison.
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within 2 weeks of completion of treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Timing data
Periodo de tiempo: within 2 weeks of patient completion of treatment
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Completion of data on time taken for setup, imaging, and total appointment time
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within 2 weeks of patient completion of treatment
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Assessment of imaging to determine intra-fraction motion
Periodo de tiempo: within 2 weeks of patient completion of treatment
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Comparison of verification imaging with in-treatment imaging records to determine magnitude of intra-fraction motion.
These will be assessed per patient and compared between both groups.
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within 2 weeks of patient completion of treatment
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Patient acceptance and tolerability of immobilisation shells (pre-treatment)
Periodo de tiempo: within 2 weeks of patient completion of treatment
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Patient completion of questionnaire to determine acceptance and tolerability of immobilisation shell during fabrication (moulding) and planning CT scan.
All three patient questionnaires will be analysed separately and together to determine any differences between both groups.
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within 2 weeks of patient completion of treatment
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Patient acceptance and tolerability of immobilisation shells (1st fraction)
Periodo de tiempo: within 2 weeks of patient completion of treatment
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Patient completion of questionnaire to determine acceptance and tolerability of immobilisation shell during first radiotherapy treatment session.
All three patient questionnaires will be analysed separately and together to determine any differences between both groups.
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within 2 weeks of patient completion of treatment
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Patient acceptance and tolerability of immobilisation shells (last fraction)
Periodo de tiempo: within 2 weeks of patient completion of treatment
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Patient completion of questionnaire to determine acceptance and tolerability of immobilisation shell during last radiotherapy treatment session.
All three patient questionnaires will be analysed separately and together to determine any differences between both groups.
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within 2 weeks of patient completion of treatment
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Radiographer satisfaction of using immobilisation shells (pre-treatment)
Periodo de tiempo: within 2 weeks of patient completion of treatment
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Radiographer completion of questionnaire to determine satisfaction with fabrication and use of immobilisation shell during pre-treatment stages.
Pre-treatment and treatment questionnaires will be analysed individually and together to determine any differences between both groups.
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within 2 weeks of patient completion of treatment
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Radiographer satisfaction of using immobilisation shells (treatment)
Periodo de tiempo: within 2 weeks of patient completion of treatment
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Radiographer completion of questionnaire to determine satisfaction with use of immobilisation shell during treatment.
The same questionnaire is used at the first and last fraction of treatment.
Pre-treatment and treatment questionnaires will be analysed individually and together to determine any differences between both groups.
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within 2 weeks of patient completion of treatment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Liam Welsh, PhD, FRCR, Royal Marsden NHS Foundation Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- CCR4362
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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