Comparing Immobilisation Shells in Cranial Radiotherapy

NCT02599142 | Completed

• 1 other identifier: CCR4362
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brain Metastases; Bone Metastases; Brain Tumor, Primary; Brain Tumor Adult; Brain Tumor - Metastatic

Keywords

radiotherapy immobilisation; open-face shells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Timing data

  within 2 weeks of patient completion of treatment

• Assessment of imaging to determine intra-fraction motion

  within 2 weeks of patient completion of treatment

• Patient acceptance and tolerability of immobilisation shells (pre-treatment)

  within 2 weeks of patient completion of treatment

• Patient acceptance and tolerability of immobilisation shells (1st fraction)

  within 2 weeks of patient completion of treatment

• Patient acceptance and tolerability of immobilisation shells (last fraction)

  within 2 weeks of patient completion of treatment

Study Arms (2)

Group A: Closed-face shells

ACTIVE COMPARATOR

Cranial radiotherapy using the control closed-face immobilisation shell.

Device: Group A: Closed-face shell

Group B: open-face shell

EXPERIMENTAL

Cranial radiotherapy using the experimental open-face immobilisation shell

Device: Group B: Open-face shell

Interventions

Group A: Closed-face shell DEVICE

As for arm description

Group A: Closed-face shells

Group B: Open-face shell DEVICE

As for arm description

Group B: open-face shell

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients prescribed cranial radiotherapy using virtually simulated parallel opposed fields with:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Liam Welsh, PhD, FRCR

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: November 1, 2015
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 6 months after publication for a period of one year.
• Access Criteria: Requests via corresponding author for interested parties working in the field of Radiation Oncology. Information will be shared by corresponding author.

Locations

GB (1)