- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Ghent, Belgia
- Department of Radiotherapy, University Hospital Ghent
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Leuven, Belgia
- Department of Radiotherapy, University Hospital Leuven
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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HNC patients
head and neck cancer patients
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in dysphagia
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: up to three years after study start
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up to three years after study start
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in weight loss
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Kim De Ruyck, Dr., Ghent University - Department of Basic Medical Sciences
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2013/895
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