NCT05348486Recruiting
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
Source: ClinicalTrials.gov · Last updated 22 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 20 Apr 2022
- Start date
- 20 Apr 2022
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- University Hospital Olomouc
- Diseases
- Head and neck cancer
- NCT number
- NCT05348486
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 20 Apr 2022 to the primary completion date, 30 Jun 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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 Hepatitis B or C
- History of Human Immunodeficiency Virus (HIV)
- Active infection requiring systemic therapy
Other
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or any distant metastasis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Masaryk Memorial Cancer Institute Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Radiation oncology department in Palacký University and University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| Faculty Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.