Status:
RECRUITING
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Insel Gruppe AG, University Hospital Bern
University Hospital, Geneva
Conditions:
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 i...
Detailed Description
Local treatment of squamous cell carcinoma (SCC) of the oropharynx can consist of surgery, radiotherapy, or a combination of both. When treated with radiation, the target volume contains not only the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06563362
Start Date
February 4 2025
End Date
February 28 2030
Last Update
November 18 2025
Active Locations (5)
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1
Zurich University Hospital
Zurich, Canton of Zurich, Switzerland, 8091
2
Cantonal Hospital Aarau
Aarau, Switzerland
3
Ospedale Regionale di Bellinzona
Bellinzona, Switzerland
4
Inselspital Bern
Bern, Switzerland