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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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London, Reino Unido, SW3 6JJ
- Royal Marsden Hospital NHS Foundation Trust
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Group A: Closed-face shells
Cranial radiotherapy using the control closed-face immobilisation shell.
|
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Timing data
Prazo: within 2 weeks of patient completion of treatment
|
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
Prazo: 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
|
|
Patient acceptance and tolerability of immobilisation shells (pre-treatment)
Prazo: 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
|
|
Patient acceptance and tolerability of immobilisation shells (1st fraction)
Prazo: within 2 weeks of patient completion of treatment
|
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.
|
within 2 weeks of patient completion of treatment
|
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Patient acceptance and tolerability of immobilisation shells (last fraction)
Prazo: within 2 weeks of patient completion of treatment
|
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.
|
within 2 weeks of patient completion of treatment
|
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Radiographer satisfaction of using immobilisation shells (pre-treatment)
Prazo: 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
|
|
Radiographer satisfaction of using immobilisation shells (treatment)
Prazo: within 2 weeks of patient completion of treatment
|
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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Liam Welsh, PhD, FRCR, Royal Marsden NHS Foundation Trust
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CCR4362
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
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