Adaptive radiotherapy using FMISO for head and neck cancer
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
This study is testing if using special imaging to find hard-to-treat areas in head and neck cancer can help doctors give higher doses of radiation where it's needed most, along with chemotherapy, to improve patient outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Olomouc Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Brno and 2 other locations) |
| Trial ID | NCT05348486 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with newly diagnosed, pathologically confirmed squamous cell carcinoma of the oropharynx, larynx, hypopharynx, or oral cavity at clinical stages III or IV.
Not a fit: Patients who have undergone prior surgical treatment or systemic therapy for head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with head and neck cancer by effectively targeting resistant tumor regions.
How similar studies have performed: Other studies have shown promise in using imaging-guided dose escalation in radiotherapy, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brno and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.