Actively Recruiting
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
Led by University Hospital Olomouc · Updated on 2025-04-22
120
Participants Needed
3
Research Sites
427 weeks
Total Duration
On this page
Sponsors
U
University Hospital Olomouc
Lead Sponsor
M
Masaryk Memorial Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed new diagnosis of oropharyngeal p16 negative, laryngeal, hypopharyngeal, or oral cavity squamous cell carcinoma at clinical stage III or IV limited to head and neck
- Tumor burden evaluable by CT or MRI based on RECIST version 1.1
- Eligible for definitive chemoradiation or hyperfractionated accelerated radiotherapy
- ECOG performance status of 0 or 1
- Adequate kidney and liver function
You will not qualify if you...
- Prior surgery on primary tumor or involved lymph nodes except diagnostic biopsy
- Previous systemic therapy, targeted therapy, or radiotherapy for head and neck cancer
- Cancer outside oropharynx, larynx, hypopharynx, or oral cavity (e.g., nasopharyngeal, sinus, other para-nasal, or unknown primary)
- Known active central nervous system metastases, carcinomatous meningitis, or distant metastasis
- Known active Hepatitis B or C infection
- History of HIV infection
- History of treated hematologic or solid tumors unless remission for at least 5 years prior
- Previous allogeneic tissue or solid organ transplant
- Active infection needing systemic treatment
AI-Screening
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Trial Site Locations
Total: 3 locations
1
The Masaryk Memorial Cancer Institute
Brno, Czechia
Actively Recruiting
2
Radiation oncology department in Palacký University and University Hospital Olomouc
Olomouc, Czechia
Actively Recruiting
3
Faculty Hospital Ostrava
Ostrava, Czechia
Actively Recruiting
Research Team
M
Martin Dolezel, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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