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Comparing Immobilisation Shells in Cranial Radiotherapy (CORIOLIS)

1. maj 2020 opdateret af: Royal Marsden NHS Foundation Trust

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group A: Closed-face shells
Cranial radiotherapy using the control closed-face immobilisation shell.
Enhed: Group A: Closed-face shell
As for arm description
Eksperimentel: Group B: open-face shell
Cranial radiotherapy using the experimental open-face immobilisation shell
Enhed: Group B: Open-face shell
As for arm description

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
Tidsramme: 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.
within 2 weeks of completion of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Timing data
Tidsramme: within 2 weeks of patient completion of treatment
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
Tidsramme: within 2 weeks of patient completion of treatment
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)
Tidsramme: within 2 weeks of patient completion of 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)
Tidsramme: 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
Patient acceptance and tolerability of immobilisation shells (last fraction)
Tidsramme: 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
Radiographer satisfaction of using immobilisation shells (pre-treatment)
Tidsramme: within 2 weeks of patient completion of 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)
Tidsramme: 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.
within 2 weeks of patient completion of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Royal Marsden NHS Foundation Trust

Samarbejdspartnere

National Institute for Health Research, United Kingdom

Efterforskere

  • Ledende efterforsker: Liam Welsh, PhD, FRCR, Royal Marsden NHS Foundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2015

Primær færdiggørelse (Faktiske)

22. oktober 2018

Studieafslutning (Faktiske)

22. oktober 2018

Datoer for studieregistrering

Først indsendt

4. november 2015

Først indsendt, der opfyldte QC-kriterier

5. november 2015

Først opslået (Skøn)

6. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CCR4362

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All IPD that underlie results in publication

IPD-delingstidsramme

Starting 6 months after publication for a period of one year.

IPD-delingsadgangskriterier

Requests via corresponding author for interested parties working in the field of Radiation Oncology. Information will be shared by corresponding author.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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Kliniske forsøg med Group A: Closed-face shell

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