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Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma

RecruitingPhase 2

Sponsor: University of Zurich

Conditions: Oropharynx Cancer

Interventions: De-escalation of irradiated volume

Countries: Switzerland

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.
* History/physical examination within 30 days prior to study inclusion by head and neck surgeon and/or radiation oncologist.
* FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory.
* Participants need to provide informed consent.

Exclusion Criteria:

Inclusion Criteria:

* 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.
* History/physical examination within 30 days prior to study inclusion by head and neck surgeon and/or radiation oncologist.
* FDG-PET scan prior to study inclusion. In case of inability to perform or contra-indication, at least contrast enhanced MRI scan obligatory.
* Participants need to provide informed consent.

Exclusion Criteria:

* Multilevel primary tumors extending unambiguously beyond the oropharynx into the oral cavity, naso- or hypopharynx
* Distant metastases detected.
* Previous surgery, chemotherapy or radiotherapy treatment for other head and neck cancers.
* Previous surgery in head and neck region affecting the cervical lymphatic system. Dissection of singular lymph nodes for diagnostic purposes before treatment start is allowed.
* Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or intermediate- risk prostate cancer or breast with a progression-free follow-up time of at least 3 years without any remaining disease burden, or other previous malignancy with a progression-free interval of at least 5 years without any remaining active/progressive disease burden regardless whether the treatment is completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy for prostate cancer).
* Pregnancy or breast feeding
* Any severe mental or psychic disorder affecting decision making and ability to provide informed consent.

Locations (7)

Zurich, Canton of Zurich, Switzerland
Aarau, Switzerland
Bellinzona, Switzerland
Bern, Switzerland
Geneva, Switzerland
Neuchâtel, Switzerland
Winterthur, Switzerland