- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Ghent, Belgio
- Department of Radiotherapy, University Hospital Ghent
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Leuven, Belgio
- Department of Radiotherapy, University Hospital Leuven
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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HNC patients
head and neck cancer patients
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in dysphagia
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: up to three years after study start
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up to three years after study start
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in weight loss
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kim De Ruyck, Dr., Ghent University - Department of Basic Medical Sciences
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2013/895
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro testa e collo
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Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Stati Uniti, Singapore, Canada