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Comparing Immobilisation Shells in Cranial Radiotherapy (CORIOLIS)

1 mai 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

41

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Royaume-Uni
      • London, Royaume-Uni, SW3 6JJ
        • Royal Marsden Hospital NHS Foundation Trust

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Group A: Closed-face shells
Cranial radiotherapy using the control closed-face immobilisation shell.
Dispositif: Group A: Closed-face shell
As for arm description
Expérimental: Group B: open-face shell
Cranial radiotherapy using the experimental open-face immobilisation shell
Dispositif: Group B: Open-face shell
As for arm description

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Timing data
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Royal Marsden NHS Foundation Trust

Collaborateurs

National Institute for Health Research, United Kingdom

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 novembre 2015

Achèvement primaire (Réel)

22 octobre 2018

Achèvement de l'étude (Réel)

22 octobre 2018

Dates d'inscription aux études

Première soumission

4 novembre 2015

Première soumission répondant aux critères de contrôle qualité

5 novembre 2015

Première publication (Estimation)

6 novembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 mai 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 mai 2020

Dernière vérification

1 mai 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CCR4362

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

All IPD that underlie results in publication

Délai de partage IPD

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

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Group A: Closed-face shell

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