RecruitingPhase 2NCT06563362

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

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

Sponsor

University of Zurich

Enrollment

120 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Oropharynx Cancer

Summary

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

Min Age: 18 Years

Inclusion Criteria14

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.
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 Criteria7

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.