Brain MetastasesCORIOLISNCT02599142
Comparing Immobilisation Shells in Cranial Radiotherapy
A study testing Group A: Closed-face shell and Group B: Open-face shell in people with Brain Metastases and Bone Metastases, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Bone Metastases, Brain Tumor, Primary
- What is being tested?
- Group A: Closed-face shell and Group B: Open-face shell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to 22 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Brain Metastases, Bone Metastases, Brain Tumor, Primary, Brain Tumor Adult, Brain Tumor - Metastatic
- Being tested
- Group A: Closed-face shell, Group B: Open-face shell
- Keywords
- radiotherapy immobilisation, open-face shells
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Closed-face shellDevice
As for arm description
Group B: Open-face shellDevice
As for arm description
| Study group | Role | What they receive |
|---|---|---|
| Group A: Closed-face shells | Active comparator | Cranial radiotherapy using the control closed-face immobilisation shell. Receives: Device: Group A: Closed-face shell |
| Group B: open-face shell | Experimental | Cranial radiotherapy using the experimental open-face immobilisation shell Receives: Device: Group B: Open-face shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 2 weeks of completion of treatment
Secondary outcomes (7)
Timing data
Completion of data on time taken for setup, imaging, and total appointment time
Measured: within 2 weeks of patient completion of treatment
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.
Measured: within 2 weeks of patient completion of treatment
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.
Measured: within 2 weeks of patient completion of treatment
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.
Measured: within 2 weeks of patient completion of treatment
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.
Measured: within 2 weeks of patient completion of treatment
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.
Measured: within 2 weeks of patient completion of treatment
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.
Measured: within 2 weeks of patient completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre parallel group randomised controlled trial investigating the impact of using open-face thermoplastic immobilisation shells upon setup reproducibility in patients having cranial radiotherapy.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Liam Welsh, PhD, FRCR, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599142
- Sponsor's protocol ID
- CCR4362
- Acronym
- CORIOLIS
- Status last verified
- May 2020
- First submitted
- 4 Nov 2015
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publication
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing the Accuracy and Acceptability of Closed-face and Open-face Thermoplastic Immobilisation Shells in Cranial Radiotherapy
- ClinicalTrials.gov ID
- NCT02599142
- Acronym / sponsor ID
- CORIOLIS / CCR4362
- Conditions
- Brain Metastases, Bone Metastases, Brain Tumor, Primary, Brain Tumor Adult, Brain Tumor - Metastatic
- Keywords
- radiotherapy immobilisation, open-face shells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Nov 2015 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single centre parallel group randomised controlled trial investigating the impact of using open-face thermoplastic immobilisation shells upon setup reproducibility in patients having cranial radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Group A: Closed-face shells | Active comparator | Device: Group A: Closed-face shellCranial radiotherapy using the control closed-face immobilisation shell. |
| Group B: open-face shell | Experimental | Device: Group B: Open-face shellCranial radiotherapy using the experimental open-face immobilisation shell |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: Closed-face shellAs for arm description | Device | Group A: Closed-face shells |
| Group B: Open-face shellAs for arm description | Device | Group B: open-face shell |
Primary outcome
Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
Time frame: within 2 weeks of completion of treatment
Assessment of verification imaging to determine individual systematic and random errors. Individual errors are collated to determine group systematic and random errors for comparison.
7 secondary outcomes
Timing data
Time frame: within 2 weeks of patient completion of treatment
Assessment of imaging to determine intra-fraction motion
Time frame: within 2 weeks of patient completion of treatment
Patient acceptance and tolerability of immobilisation shells (pre-treatment)
Time frame: within 2 weeks of patient completion of treatment
Patient acceptance and tolerability of immobilisation shells (1st fraction)
Time frame: within 2 weeks of patient completion of treatment
Patient acceptance and tolerability of immobilisation shells (last fraction)
Time frame: within 2 weeks of patient completion of treatment
Radiographer satisfaction of using immobilisation shells (pre-treatment)
Time frame: within 2 weeks of patient completion of treatment
Radiographer satisfaction of using immobilisation shells (treatment)
Time frame: within 2 weeks of patient completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam Welsh, PhD, FRCR principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: Closed-face shell and Group B: Open-face shell in people with Brain Metastases and Bone Metastases, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells (time frame: within 2 weeks of completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.