Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
DAHANCA Proton Feasibility Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In preparation for a randomised study in Denmark (DAHANCA 35) the feasibility of selecting newly diagnosed patients with squamous cell carcinoma of the pharynx or larynx for proton therapy at the local treatment centers is investigated. A proton and a photon doseplan is prepared for patients planned for primary radiotherapy . If proton radiotherapy reduces the anticipated absolute risk of dysphagia >= grade 2 (DAHANCA scale and/or xerostomia >= grade 2 (EORTC Head-Neck 35) with a clinical relevant value the patient is offered proton therapy at the Danish Center for Particle Therapy. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP).
At least five patients from each of the six Danish centers are required in this feasibility study.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Aalborg, Danemark
- Aalborg University Hospital
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Aarhus, Danemark
- Aarhus University Hospital
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Aarhus, Danemark
- Danish Center for Particle Therapy
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Copenhagen, Danemark
- Rigshospitalet
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Herlev, Danemark
- Herlev Hospital
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Næstved, Danemark
- Næstved Hospital
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Odense, Danemark
- Odense University Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent
A predicted clinical significant reduction in the risk of any of the two primary endpoints (>= grade 2 observer-rated dysphagia or grade 2 patient-reported xerostomia) after proton therapy compared to photon therapy based on comparison of the individual patient dose plans
No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer
Informed consent as required by law
Above 18 years of age
Exclusion Criteria:
Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area, nasopharynx, unknown primary tumor and prior malignancies.
Patients with contraindications for proton therapy (as per 2019 pacemakers, implanted defibrillators and tracheostomy)
Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
Distant metastasis
Previous radiotherapy of the head and neck
Previous surgery for the primary cancer with curative intent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Proton radiotherapy
Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA).
Treatment: 66-68 Gy/ 33-34 fx/ 6/W,with cisplatin 40 mg/m2/W and nimorazole to suitable patients
|
Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA).
Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dysphagie >= grade 2
Délai: Six mois après la fin de la radiothérapie
|
Le taux de dysphagie signalée par l'observateur> = grade 2 mesuré par le score de toxicité tardive DAHANCA (grade 0-4, 0 étant le meilleur)
|
Six mois après la fin de la radiothérapie
|
|
Xerostomia = grade 2
Délai: Six months after end of radiotherapy
|
The rate of patient-reported xerostomia measured by the EORTC Quality of life questionnaire (QLQ) Head-Neck (HN) 35 (grade 1-4, with 1 being best)
|
Six months after end of radiotherapy
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Loco-regional tumor control
Délai: Up to five years after end of radiotherapy
|
Time to event of local-regional failure, from date of randomization to the date of first documented loco-regional failure. Rates are estimated by the Kaplan-Meier method. Interim analyses after 100, 200 and 300 patients. Will not be reported before the primary endpoint. |
Up to five years after end of radiotherapy
|
|
Overall survival
Délai: Up to five years after end of radiotherapy]
|
From date of randomisation to date of death
|
Up to five years after end of radiotherapy]
|
|
Acute toxicity
Délai: From the beginning of and up to two months after end of radiotherapy]
|
DAHANCA acute toxicity score (grade 0-4, 0 being best)
|
From the beginning of and up to two months after end of radiotherapy]
|
|
Late toxicity
Délai: From two months to five years after end of radiotherapy]
|
DAHANCA late toxicity score (grade 0-4, 0 being best)
|
From two months to five years after end of radiotherapy]
|
|
EORTC QLQ-Head-Neck 35
Délai: Up to five years after end of radiotherapy
|
Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best)
|
Up to five years after end of radiotherapy
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|
EORTC C30
Délai: Up to five years after end of radiotherapy]
|
Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)
|
Up to five years after end of radiotherapy]
|
|
Time from referral to treatment
Délai: From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
|
Time from referral to proton center to first proton treatment
|
From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jeppe Friborg, MD, PhD, Danish Head-Neck Cancer Group (DAHANCA)
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DAHANCA proton feasibility
Informations sur les médicaments et les dispositifs, documents d'étude
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