Adaptive radiotherapy using FMISO for head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of FMISO PET/CT imaging to identify hypoxic regions in head and neck tumors, which are often resistant to radiation. The study employs a dose escalation approach, where higher doses of radiotherapy are targeted specifically at these hypoxic areas to improve treatment efficacy. Patients will receive concurrent chemotherapy with cisplatin while undergoing radiotherapy, with careful monitoring of their health throughout the treatment process. The trial aims to enhance the precision of radiotherapy by tailoring doses based on tumor hypoxia.

Why it matters

Who can join: the full rules

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

Where it's running

• The Masaryk Memorial Cancer Institute
  Brno, Czechia Recruiting
• Radiation oncology department in Palacký University and University Hospital Olomouc
  Olomouc, Czechia Recruiting
• Faculty Hospital Ostrava
  Ostrava, Czechia Recruiting

Study contacts

• Principal investigator: Martin Dolezel, Prof. — Palacký University and University Hospital Olomouc
• Study coordinator: Martin Dolezel, Prof
• Email: dolezelm@email.cz
• Phone: +420588444295

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.