The aim of the study is to determine the feasibility and efficacy of moderate weekly whole Body hyperthermia Treatment during radiochemotherapy for pre-irradiated locally or regionally recurrent head and neck squamous cell carcinomas. The Primary aim of the study is feasibility, defined as 80% of patients completing at least four applications of hyperthermia. Secondary endpoints include an increase of Tumor Perfusion by the use of hyperthermia, measured by magnetic resonance Imaging during week two of Treatment and reduction of Tumor hypoxia, measured by hypoxia specific Positron emission tomography.
Previously irradiated patients with loco/ loco-regional recurrent head and neck squamous cell carcinomas usually undergo re-irradiation. However prognosis of these patients is unfavourable, especially for non-human papilloma virus associated cancers. Moderate whole body hyperthermia will be performed by water-filtered IR-A-radiation using a Heckel-HT3000 device. Preclinical data have indicated that moderate whole body hyperthermia decreases intratumoral interstitial fluid pressure and leads to increased perfusion of the tumor. The study investigates if this holds also true in patients and leads to a marked decrease of tumor hypoxia, measured by 18F-Fluoromisonidazole PET. The Primary aim of the study is feasibility, defined as 80% of patients completing at least four applications of hyperthermia. Secondary endpoints include an increase of Tumor Perfusion by the use of hyperthermia, measured by magnetic resonance Imaging during week two of Treatment and reduction of Tumor hypoxia, measured by hypoxia specific Positron emission tomography.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
four to six applications of whole Body hyperthermia concomitant to radiochemotherapy. Additional measurement of Perfusion and hypoxia by 18F-FMISO hypoxia PET and magnetic resonance Imaging
Klinik für Radioonkologie und Strahlentherapie
Berlin, Germany
feasibility of whole body hyperthermia as adjunct to radiochemotherapy
feasibility is defined as at least 4 cycles of whole body hyperthermia in 80% of patients
Time frame: within 6 weeks of treatment with radiochemotherapy
Reduction of positron emission tomography (PET) measured hypoxia
defined as at least 80% reduction of the tumor to background ratio measured at the end of the second week of treatment compared to pre-treatment
Time frame: 1 year (recruitment) plus additional 2 weeks (evaluation of PET parameter)
magnetic resonance imaging (MRI) measured perfusion changes
measured before treatment and at the end of week 2
Time frame: 1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter)
Patient reported quality of life (head and neck cancer specific quality of life)
measured by questionnaires according to EORTC (H\&N35) and Transformation of absolute values to percentual values.
Time frame: 3 years (i.e. recruitment plus two years of follow-up)
Patient reported quality of life (general quality of life)
measured by questionnaires according to EORTC (C30) and Transformation of absolute values to percentual values.
Time frame: 3 years (i.e. recruitment plus two years of follow-up)
Local control after 2 years of follow-up
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
Time frame: 3 years (1 year recruitment, 2 years follow-up)
Loco-regional control after 2 years of follow-up
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
Time frame: 3 years (1 year recruitment, 2 years follow-up)
Overall survival after 2 years of follow-up
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
Time frame: 3 years (1 year recruitment, 2 years follow-up)
Freedom from distant metastases after 2 years of follow-up
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
Time frame: 3 years (1 year recruitment, 2 years follow-up)
Tumor response
Response of the irradiated tumor 3 months after end of treatment according to recist criteria
Time frame: 1 year (recruitment) and 3 months (follow-up)
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