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Tobed Secall, Marc
López-Bermejo, Abel |
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Universitat de Girona. Facultat de Medicina | |
Santaló Corcoy, Meritxell | |
2020 January | |
BACKGROUND: New epidemiological data indicate that the incidence of oropharyngeal
squamous cell carcinomas (OPSCC) is rapidly increasing due to human papillomavirus (HPV).
Patients that suffer from a HPV-related OPSCC present distinct characteristics such as younger
age, early T-stage but more advanced N-stage, absence of tobacco and alcohol as risk factors,
but, more importantly, a significantly better prognosis. Despite their better outcome, these
patients are still being treated with the same protocols as not HPV-related tumors and thus, are
exposed to the same toxicity and the potentially unnecessary side-effects should not be
underestimated. Several protocols of treatment de-escalation are under study in subgroups of
patients with different characteristics. In the current study, we will address patients with the
best prognosis in order to limit the possibility of negatively affecting the oncologic control. For
this purpose we will, incorporate CD8+ tumor infiltrating lymphocytes (TILs) as an additional
inclusion criteria.
OBJECTIVES: The aim of this study is to prove that de-escalation of the radiotherapeutic
adjuvant treatment in patients with HPV-related OPSCC in early stages and displaying additional
good prognosis factors, is non-inferior in terms of overall survival. As secondary outcomes we
will address local recurrence and post-treatment swallowing dysfunction.
DESIGN AND SETTING: This is designed as a multicentre, randomized, open-labelled non-
inferiority clinical trial. It will be performed among four tertiary hospitals of Catalonia.
PARTICIPANTS: patients aged between 18 and 60 years, with HPV-related OPSCC that have high
numbers of CD8+ TILs, are tributary to transoral robotic surgery and have a T-stage <3 and N-
stage | |
application/pdf | |
http://hdl.handle.net/10256/18527 | |
eng | |
Attribution-NonCommercial-NoDerivatives 4.0 International | |
http://creativecommons.org/licenses/by-nc-nd/4.0/ | |
Boca -- CÃ ncer -- Prognosi
Mouth -- Cancer -- Prognosis Faringe -- Cà ncer -- Prognosi Pharynx -- Cancer -- Prognosis Papil·lomavirus Papillomaviruses DEM |
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De-escalation of the adjuvant radiotherapy doses in patients with HPV-related oropharyngeal tumors with high levels of CD8+ tumor infiltrating lymphocytes: a multicentre, randomized, controlled clinical trial | |
info:eu-repo/semantics/bachelorThesis | |
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