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Brief Title: FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
Official Title: FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
Study ID: NCT05348486
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 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.
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 chemotherapy cisplatin will be administered weekly 35-40 mg/m2 or every three weeks 80-100 mg/m2. The parameter of cumulative cisplatin dose of 200 mg/m2 during the whole course of radiotherapy will be also taken into account. Patients will be examined and monitored at least every two weeks. Target volumes and dose and fractionation: Definition of gross tumor volumes (GTV), clinical target volumes (CTV) and planning target volumes (PTV) will follow recommendations of DAHANCA, EORTC and RTOG guidelines. The conventional radiotherapy protocol: Standard fractionation regimen: 70 Gy/54 Gy in 33 fractions GTV primary - CTV - PTV (5+5mm): for dose 70 Gy in 33 fractions GTV LN bulky (\> 3cm) - PTV (5mm): for dose 70 Gy in 33 fractions LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy in 33 fractions Dose escalated radiotherapy protocol: 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 in 33 fractions (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 in 33 fractions LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy in 33 fractions
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Masaryk Memorial Cancer Institute, Brno, , Czechia
Radiation oncology department in Palacký University and University Hospital Olomouc, Olomouc, , Czechia
Faculty Hospital Ostrava, Ostrava, , Czechia
Name: Martin Dolezel, Prof.
Affiliation: Palacký University and University Hospital Olomouc
Role: PRINCIPAL_INVESTIGATOR
Name: Marek Slavik, Ph.D.
Affiliation: The Masaryk Memorial Cancer Institute (MMCI)
Role: STUDY_CHAIR
Name: Jakub Cvek, Prof.
Affiliation: Faculty Hospital Ostrava
Role: STUDY_CHAIR