Multicentric prospective model-based de-escalation of the elective clinical target volumes (CTV) in radiotherapy of oropharyngeal carcinoma of all stages with the goal to reduce toxicity.
The study investigates the feasibility of this approach as measured by the number of expected out-of-field recurrencies based on the individual patient's state of disease progression and risk factors
Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.
Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes.
Age ≥ 18 years, no upper age limit.
ECOG performance score < 3.
Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface of epiglottis; ICD-10 codes C01, C09, C10), T1-4, N0-3.
Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of the lymph nodes.
Age ≥ 18 years, no upper age limit.
ECOG performance score < 3.
Single group
De-escalation of irradiated volume
RadiationDe-escalation of elective clinical target volumes as recommended by a model-based approach
out-of field nodal recurrence rate at 2 years
efficacy of personalized CTV-N reduction in oropharyngeal SCC patients 2 years after the end of the primary (chemo)radiotherapy treatment measured by the Kaplan-Meier estimator for the cumulative probability of out-of-field N-site recurrences (incidence of lymph node metastases in non-irradiated LNLs).
out-of field nodal recurrence rate at 3 years
efficacy of personalized CTV-N reduction in oropharyngeal SCC patients measured by the Kaplan-Meier estimator for the cumulative probability of out-of-field N-site recurrences (incidence of lymph node metastases in non-irradiated LNLs)
Loco-regional control (LCR) rate at 2 years
assessed by the Kaplan-Meier estimator for the cumulative probability of local recurrence of the primary tumor or recurrence in any cervical LNL (both irradiated and non-irradiated LNLs)
Loco-regional control (LCR) rate at 3 years
assessed by the Kaplan-Meier estimator for the cumulative probability of local recurrence of the primary tumor or recurrence in any cervical LNL (both irradiated and non-irradiated LNLs)
Progression-free survival (PFS) at 2 years
assessed by the Kaplan-Meier estimator for the cumulative probability of any local, regional, distant progression or death
Assessement of values and longitudinal changes in total blood count, including lymphocytes (explorative assessement)
Full blood count will be longitudinally assessed at begin of treatment and at every follow up (descriptive analyses and correlation with all oncological outcomes)
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University of Zurich
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborator
University Hospital, Geneva
Collaborator
Ospedale Regionale Bellinzona e Valli
Collaborator
Réseau Hospitalier Neuchâtelois
Collaborator
Kantonsspital Aarau
Collaborator
Kantonsspital Winterthur KSW
Collaborator
