Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- feasibility of whole body hyperthermia as adjunct to radiochemotherapy
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single Arm
Additional application of weekly moderate whole-body hyperthermia concurrent to re-irradiation plus chemotherapy
Intervention: Moderate whole body hyperthermia using water-filtered IR-A-radiation (Device)
Outcomes
Primary Outcomes
feasibility of whole body hyperthermia as adjunct to radiochemotherapy
Time Frame: within 6 weeks of treatment with radiochemotherapy
feasibility is defined as at least 4 cycles of whole body hyperthermia in 80% of patients
Secondary Outcomes
- Freedom from distant metastases after 2 years of follow-up(3 years (1 year recruitment, 2 years follow-up))
- Reduction of positron emission tomography (PET) measured hypoxia(1 year (recruitment) plus additional 2 weeks (evaluation of PET parameter))
- magnetic resonance imaging (MRI) measured perfusion changes(1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter))
- Tumor response(1 year (recruitment) and 3 months (follow-up))
- Patient reported quality of life (head and neck cancer specific quality of life)(3 years (i.e. recruitment plus two years of follow-up))
- Local control after 2 years of follow-up(3 years (1 year recruitment, 2 years follow-up))
- Loco-regional control after 2 years of follow-up(3 years (1 year recruitment, 2 years follow-up))
- Overall survival after 2 years of follow-up(3 years (1 year recruitment, 2 years follow-up))
- Patient reported quality of life (general quality of life)(3 years (i.e. recruitment plus two years of follow-up))
Investigators
Sebastian Zschaeck
MD, Principal Investigator
Charite University, Berlin, Germany