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Recruiting NCT05348486

FMISO-based Adaptive Radiotherapy for Head and Neck Cancer

Trial Parameters

Condition Head and Neck Cancer
Sponsor University Hospital Olomouc
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-04-20
Completion 2025-06-30
Interventions
Dose escalation

Brief Summary

Hypoxia occurs in about 80% of head and neck tumors. Based on experimental and clinical data, hypoxia is a useful parameter for pretherapeutic stratification. These radioresistant regions can be detected with FMISO PET/CT. Moreover, hypoxic subvolumes of tumors can be evolving as target volumes for radiotherapy ("dose painting") in hypoxia imaging-based dose escalation.

Eligibility Criteria

Inclusion Criteria: * Pathologically proven new diagnosis of oropharyngeal p16 negative, or laryngeal, hypopharyngeal, oral cavity (independent of p16) squamous cell carcinoma of clinical stage III, IV confined to head and neck area * Evaluable tumor burden assessed by computed tomography scan or magnetic resonance imaging, based on RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1 * Eligibiity for definitive chemoradiation or hyperfractionated accelerated radiotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate kidney and liver function Exclusion Criteria: * Prior surgical treatment - any surgery of primary tumor or involved nodes or prior surgical debulking apart from surgery with diagnostic intention (e.g. open biopsy if necessary) * Prior systemic therapy, targeted therapy, radiotherapy treatment for head and neck cancer * Cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus,

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