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NCT06870799Recrutement en cours

Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy

Résumé

At present, open-face masks are used only in patients with claustrophobic anxiety, while all other patients are still immobilized with closed masks, thereby overlooking the need for improvement in patient comfort. Closed face masks in patients undergoing head and neck irradiation have never been compared to no masks in the setting of a randomized clinical trial, but only in feasibility trials. A randomized clinical trial may establish the role of no masks in terms of patient comfort, preference and setup accuracy in all patients.

Critères d'inclusion

• Written informed consent according to Swiss law and ICH/GCP regulations before any trial specific procedures; • Indication for head and neck radiotherapy irrespective of tumor type; • Age: ≥ 18 years old; • Karnofsky performance status ≥70; • Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.

Critères d'exclusion

• Prior head and neck irradiation; • Women who are pregnant or breast feeding; • Intention to become pregnant during the course of the trial; • Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases; • Known or suspected non-compliance, drug or alcohol abuse; • Inability to follow the procedures of the trial, e.g. due to language problems of the participant; • Enrolment of the investigator, his/her family members, employees and other dependent persons. • One of the following Tumor Types: Nasopharynx, Sinunasal, patients with CTV within 5 mm of eyes or spinal cord.

Contacts

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

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Statut
Recrutement en cours
Phase
Sans phase (N/A)
Type d'étude
Interventionnelle
Pays
Suisse
Promoteur
University of Zurich(Autre)
N° de protocole
RAO 24-019
Pathologies
Head and Neck Cancers
Interventions
Dispositif

Traitements évalués

  • Surface guided radiation therapy
  • Closed face mask

Lieux · 1

  • Zurich, SuisseUniversity Hospital ZurichRecrute dans ce centre

Au total, dans le monde, le seul centre listé au registre recrute.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 20 août 2026).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

Autres identifiants

  • 2025-D0007 · autre identifiant

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.