Brain Metastases Clinical Trial
— CORIOLISOfficial title:
A Randomised Controlled Trial Comparing the Accuracy and Acceptability of Closed-face and Open-face Thermoplastic Immobilisation Shells in Cranial Radiotherapy
NCT number | NCT02599142 |
Other study ID # | CCR4362 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | October 22, 2018 |
Verified date | May 2020 |
Source | Royal Marsden NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | October 22, 2018 |
Est. primary completion date | October 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Marsden Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust | National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells | Assessment of verification imaging to determine individual systematic and random errors. Individual errors are collated to determine group systematic and random errors for comparison. | within 2 weeks of completion of treatment | |
Secondary | Timing data | Completion of data on time taken for setup, imaging, and total appointment time | within 2 weeks of patient completion of treatment | |
Secondary | Assessment of imaging to determine intra-fraction motion | 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. | within 2 weeks of patient completion of treatment | |
Secondary | Patient acceptance and tolerability of immobilisation shells (pre-treatment) | 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. | within 2 weeks of patient completion of treatment | |
Secondary | Patient acceptance and tolerability of immobilisation shells (1st fraction) | 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 | |
Secondary | Patient acceptance and tolerability of immobilisation shells (last fraction) | 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 | |
Secondary | Radiographer satisfaction of using immobilisation shells (pre-treatment) | 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. | within 2 weeks of patient completion of treatment | |
Secondary | Radiographer satisfaction of using immobilisation shells (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. | within 2 weeks of patient completion of treatment |
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