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.

Study Overview

• Status: Completed
• Conditions: Bone Metastases; Brain Metastases; Brain Tumor, Primary; Brain Tumor Adult; Brain Tumor - Metastatic
• Intervention / Treatment: Device: Group A: Closed-face shell; Device: Group B: Open-face shell

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Closed-face shells; Cranial radiotherapy using the control closed-face immobilisation shell.	Device: Group A: Closed-face shell; As for arm description
Experimental: Group B: open-face shell; Cranial radiotherapy using the experimental open-face immobilisation shell	Device: Group B: Open-face shell; As for arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timing data	Completion of data on time taken for setup, imaging, and total appointment time	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.	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.	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.	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.	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.	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.	within 2 weeks of patient completion of treatment

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Liam Welsh, PhD, FRCR, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): October 22, 2018
• Study Completion (Actual): October 22, 2018

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimate): November 6, 2015

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: radiotherapy immobilisation; open-face shells
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: CCR4362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in publication
• IPD Sharing Time Frame: Starting 6 months after publication for a period of one year.
• IPD Sharing Access Criteria: Requests via corresponding author for interested parties working in the field of Radiation Oncology. Information will be shared by corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No