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Comparing Immobilisation Shells in Cranial Radiotherapy (CORIOLIS)

1 mei 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

41

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigd Koninkrijk
      • London, Verenigd Koninkrijk, SW3 6JJ
        • Royal Marsden Hospital NHS Foundation Trust

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Group A: Closed-face shells
Cranial radiotherapy using the control closed-face immobilisation shell.
Apparaat: Group A: Closed-face shell
As for arm description
Experimenteel: Group B: open-face shell
Cranial radiotherapy using the experimental open-face immobilisation shell
Apparaat: Group B: Open-face shell
As for arm description

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Timing data
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Royal Marsden NHS Foundation Trust

Medewerkers

National Institute for Health Research, United Kingdom

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 november 2015

Primaire voltooiing (Werkelijk)

22 oktober 2018

Studie voltooiing (Werkelijk)

22 oktober 2018

Studieregistratiedata

Eerst ingediend

4 november 2015

Eerst ingediend dat voldeed aan de QC-criteria

5 november 2015

Eerst geplaatst (Schatting)

6 november 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 mei 2020

Laatste update ingediend die voldeed aan QC-criteria

1 mei 2020

Laatst geverifieerd

1 mei 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CCR4362

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

All IPD that underlie results in publication

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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