Actively Recruiting
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
Led by University Hospital Olomouc · Updated on 2025-04-22
120
Participants Needed
3
Research Sites
260 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
Researchers are evaluating adaptive radiotherapy techniques that target hypoxic areas in head and neck cancers, which are known to be resistant to radiation. The study focuses on patients with specific types of squamous cell carcinoma in the oropharynx, larynx, hypopharynx, or oral cavity, aiming to improve treatment precision by using FMISO PET/CT imaging to identify these hypoxic tumor regions for dose escalation. The study compares two radiotherapy approaches: a dose-escalation protocol delivering 75.9 to 79.2 Gy focused on hypoxic tumor volumes, and a standard fractionation regimen delivering 70 Gy to primary tumors and involved lymph nodes. Concurrent chemotherapy with cisplatin is given weekly or every three weeks, with total doses considered. Radiotherapy planning follows established guidelines, and treatment is delivered in 33 fractions. Patients are monitored regularly, at least every two weeks. Participants will undergo imaging assessments like CT or MRI for tumor evaluation and receive ongoing monitoring during treatment. Researchers will measure outcomes including complete response rate, locoregional progression-free survival, radiation-induced side effects, overall survival, distant metastasis-free survival, quality of life changes, and development of new hypoxic tumor areas. The study duration includes follow-ups up to four years to assess both short- and long-term effects of the treatments.
CONDITIONS
Brief 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, or laryngeal, hypopharyngeal, or oral cavity squamous cell carcinoma at clinical stage III or IV limited to the head and neck area
- Tumor burden evaluable by CT or MRI based on RECIST version 1.1
- Eligible for definitive chemoradiation or hyperfractionated accelerated radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate kidney and liver function
You will not qualify if you...
- Prior surgery of the 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 such as nasopharyngeal or sinus cancer
- Active central nervous system metastases or distant metastasis
- Active Hepatitis B or C infection
- History of Human Immunodeficiency Virus (HIV) infection
- History of hematologic or primary solid tumor malignancy unless remission for at least 5 years
- Previous allogeneic tissue or organ transplant
- Active infection requiring systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6.5 weeks (33 fractions)
Participants receive radiotherapy with either standard fractionation or dose-escalated regimens targeting hypoxic tumor areas, combined with concurrent chemotherapy administered weekly or every three weeks.
At least biweekly visits for examinations and monitoring during radiotherapy
Duration - Up to 4 years
Participants are monitored for treatment response, radiation-induced events, and overall health outcomes including quality of life and survival.
Regular follow-up visits over 2 to 4 years
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
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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