- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02103010
Predictive Modelling for Patient Stratification According to Treatment-related Toxicity and Survival After Chemoradiation for Head and Neck Cancer (PRETOXIS)
Radiotherapy is an integral component of the current multimodality treatment approach in locally advanced head and neck cancer (HNC). There is growing evidence that more aggressive treatment regimens improve tumour control and survival. However, intensified treatment is at the expense of increased toxicity, in particular severe acute mucositis. In addition and of increasing importance, late and irreversible treatment-related side effects, including xerostomia and swallowing dysfunction, occur in a considerable proportion of patients and negatively affect quality of life.
High-risk human papilloma virus (HPV), specifically HPV type-16, is implicated as the causative factor in a proportion of HNC, especially those of the oropharynx. HPV-related cancers respond well to chemoradiotherapy compared to HNC related to tobacco and alcohol. Furthermore, the incidence of HPV-related oropharyngeal cancer is rising in Western countries. Given the significant toxicity associated with concurrent chemoradiotherapy, subsets of patients could be managed differently.
The first objective of the project is to develop predictive models for radiation-induced dysphagia and xerostomia in HNC patients. Clinical characteristics, treatment parameters, dose-volume effects on healthy tissues and whole-genome genetic data will be considered. The second objective of the project is to study the prognostic value of HPV status together with a panel of tumour biomarkers in oropharyngeal cancer patients. The overall aim of the project is to stratify patients according to the risks (side-effects) and benefits (survival) of cancer treatment using the developed risk models. Clustering patients into different risk categories may aid treatment decision making reducing therapy toxicity without compromising survival.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ghent, Belgique
- Department of Radiotherapy, University Hospital Ghent
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Leuven, Belgique
- Department of Radiotherapy, University Hospital Leuven
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx and larynx. Histologically confirmed cervical lymph node metastases of unknown primary cancer (CUP). For prognosis part of the study: only histologically confirmed squamous cell carcinoma of the oropharynx
- Stages : Tany N1-3, T3-4 N0, T1-2 N0, if prophylactic neck irradiation is performed
- Multidisciplinary decision of curative radiotherapy or radiochemotherapy
- Karnofsky performance status ≥ 70%
- Age ≥ 18 years old
- Gender : male - female
- Informed consent obtained, signed and dated before start of radiotherapy
Exclusion Criteria:
- Treatment combined with brachytherapy
- Treatment combined with cetuximab or other targeted agents
- Prior irradiation to the head and neck region
- History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years
- Distant metastases
- Pregnant or lactating women
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- Patients unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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HNC patients
head and neck cancer patients
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change in dysphagia
Délai: during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
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Dysphagia during radiotherapy and at 6/12/18/24 months after the end of radiotherapy using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 scale.
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during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
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change in xerostomia
Délai: during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
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xerostomia during radiotherapy and at 6/12/18/24 months after the end of radiotherapy using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 scale
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during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
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change in overall survival
Délai: up to three years after study start
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up to three years after study start
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change in disease specific survival
Délai: up to three years after study start
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up to three years after study start
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change in progression-free survival
Délai: up to three years after study start
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up to three years after study start
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appearance of distant metastasis
Délai: up to three years after study start
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up to three years after study start
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change in weight loss
Délai: during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
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during radiotherapy and at 6/12/18/24 months after the end of radiotherapy
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change of Quality of life
Délai: pre-radiotherapy, at the last day of radiotherapy and post-radiotherapy (12/24 months)
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using the EORTC (European Organisation for Research and Treatment of Cancer ) quality of life questionnaire C30 and the hand and neck cancer specific quality of life questionnaire HN35
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pre-radiotherapy, at the last day of radiotherapy and post-radiotherapy (12/24 months)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kim De Ruyck, Dr., Ghent University - Department of Basic Medical Sciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2013/895
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