Status:
RECRUITING
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
Lead Sponsor:
University Hospital Olomouc
Collaborating Sponsors:
Masaryk Memorial Cancer Institute
University Hospital Ostrava
Conditions:
Head and Neck Cancer
Hypoxia
Eligibility:
All Genders
18+ years
Phase:
NA
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 detec...
Detailed Description
The radiotherapy protocol will include two dose-escalation regimens. The dose in hypoxic tumor volume will be escalated either by conventional RT or stereotactic radiotherapy technique. Concurrent che...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05348486
Start Date
April 20 2022
End Date
June 30 2030
Last Update
April 22 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
The Masaryk Memorial Cancer Institute
Brno, Czechia
2
Radiation oncology department in Palacký University and University Hospital Olomouc
Olomouc, Czechia
3
Faculty Hospital Ostrava
Ostrava, Czechia