Cerebral Hypoxia Clinical Trials

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FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study

Status: Recruiting
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Contact Information
Primary
Martin Dolezel, Prof
dolezelm@email.cz
+420588444295
Time Frame
Start Date: 2022-04-20
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 120
Treatments
Experimental: Dose escalation
Dose escalated radiotherapy protocol: 75,9 - 79,2 Gy in 33 fractions GTV hypoxic or any hypoxic LN \> 2cm - PTV (0mm): dose 75,9 - 79,2 Gy/33 (Contours must be subtracted and reduce by 3mm in case of close relation to the skin, bones or large blood vessels) GTV primary - CTV - PTV (5+5mm): for dose 70 Gy/33 LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy/33
No_intervention: Standard fractionation
Standard fractionation regimen: 70 Gy/54 Gy in 33 fractions GTV primary - CTV - PTV (5+5mm): for dose 70 Gy/33 GTV LN bulky (\> 3cm) - PTV (5mm): for dose 70 Gy/33 LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy/33
Related Therapeutic Areas
Sponsors
Leads: University Hospital Olomouc
Collaborators: University Hospital Ostrava, Masaryk Memorial Cancer Institute

This content was sourced from clinicaltrials.gov