NCT06563362Recrutement en cours
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma
Résumé
Multicentric prospective model-based de-escalation of the elective clinical target volumes (CTV) in radiotherapy of oropharyngeal carcinoma of all stages with the goal to reduce toxicity. The study investigates the feasibility of this approach as measured by the number of expected out-of-field recurrencies based on the individual patient's state of disease progression and risk factors
Critères d'éligibilité
Inclusion Criteria: • Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3. • Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes. • Age ≥ 18 years, no upper age limit. • ECOG performance score \< 3. • History/physical examination within 30 days prior to study inclusion by head and neck surgeon and/or radiation oncologist. • FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory. • Participants need to provide informed consent. Exclusion Criteria: Inclusion Criteria: • Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3. • Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes. • Age ≥ 18 years, no upper age limit. • ECOG performance score \< 3. • History/physical examination within 30 days prior to study inclusion by head and neck surgeon and/or radiation oncologist. • FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory. • Participants need to provide informed consent. Exclusion Criteria: • Multilevel primary tumors extending unambiguously beyond the oropharynx into the oral cavity, naso- or hypopharynx • Distant metastases detected. • Previous surgery, chemotherapy or radiotherapy treatment for other head and neck cancers. • Previous surgery in head and neck region affecting the cervical lymphatic system. Dissection of singular lymph nodes for diagnostic purposes before treatment start is allowed. • Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or intermediate- risk prostate cancer or breast with a progression-free follow-up time of at least 3 years without any remaining disease burden, or other previous malignancy with a progression-free interval of at least 5 years without any remaining active/progressive disease burden regardless whether the treatment is completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy for prostate cancer). • Pregnancy or breast feeding • Any severe mental or psychic disorder affecting decision making and ability to provide informed consent.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 2
- Type d'étude
- Interventionnelle
- Pays
- Suisse
- Promoteur
- University of Zurich(Autre)
- N° de protocole
- DeEscO
- Pathologies
- Oropharynx Cancer
- Interventions
- Radiothérapie
Traitements évalués
- De-escalation of irradiated volume
Collaborateurs
Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, Ospedale Regionale Bellinzona e Valli, Réseau Hospitalier Neuchâtelois, Kantonsspital Aarau, Kantonsspital Winterthur KSW
Lieux · 7
- Zurich, SuisseZurich University HospitalRecrute dans ce centre
- Aarau, SuisseCantonal Hospital AarauRecrute dans ce centre
- Bellinzona, SuisseOspedale Regionale di BellinzonaRecrute dans ce centre
- Bern, SuisseInselspital BernRecrute dans ce centre
- Geneva, SuisseHôpitaux universitaires de GenèveRecrute dans ce centre
- Neuchâtel, SuisseRéseau Hospitalier NeuchâteloisRecrute dans ce centre
- Winterthur, SuisseKantonsspital WinterthurRecrute dans ce centre
Au total, dans le monde, les 7 centres listés au registre recrutent.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 8 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.