Moderate Whole Body Hyperthermia for Patients Undergoing Re-irradiation for Head and Neck Cancer -Influence on the Tumor Microenvironment (GKH-TMM)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- patients with unresectable local, regional or loco-regional recurrent non HPV-associated squamous cell head and neck cancer with prior high-dose radiotherapy of the head and neck region
- time interval of 6 months to 5 years after completion of last radiotherapy of the head and neck region
- Completed staging examinations, preferentially 18f-fluorodeoxyglucose (FDG) PET of the whole body
- general health condition according to ECOG status of 0,1 or 2
- age between 18 and 75 years
- written informed consent
Exclusion criteria
- HPV associated primary tumor or recurrent tumor
- recurrence more than 5 years after end of previous radiotherapy
- Any medical circumstances impeding the application of radiotherapy, concomitant chemotherapy or whole body hyperthermia
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal