FMISO-based Adaptive Radiotherapy for Head and Neck Cancer

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

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, other para-nasal, or unknown primary head and neck cancer
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or any distant metastasis
* Known active Hepatitis B or C
* History of Human Immunodeficiency Virus (HIV)
* History of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
* Previous allogeneic tissue/solid organ transplant
* Active infection requiring systemic therapy

Conditions5

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