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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Dose escalation 75,9 - 79,2 Gy in 33 fractions for GTV hypoxic or any hypoxic LN \> 2cm
The Masaryk Memorial Cancer Institute
Brno, Czechia
RECRUITINGRadiation oncology department in Palacký University and University Hospital Olomouc
Olomouc, Czechia
RECRUITINGFaculty Hospital Ostrava
Ostrava, Czechia
RECRUITINGComplete response rate
response rate
Time frame: 2-year
Locoregional progresion free survival
locoregional progresion free survival
Time frame: 2-year
Rate of acute (<3 months) radiation-induced events according to CTCAE 5.0
acute radiation-induced events
Time frame: 3 months
Rate of late radiation-induced events according to CTCAE 5.0
late radiation-induced events
Time frame: 2-year
Overall survival
overall survival
Time frame: 4 years
Distant metastasis free survival
distant metastasis free survival
Time frame: 4 years
Change in QoL according to the standardised EQ-5D questionnaire
QoL according to the standardised EQ-5D questionnaire
Time frame: 2 years
Rate of new hypoxic areas after two weeks of radiotherapy
rate of new hypoxic areas after two weeks of radiotherapy
Time frame: 2 week after start of radiotherapy
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