Clinical trial NCT03547388: Moderate Whole Body Hyperthermia for Patients Undergoing Re-irradiation for Head and Neck Cancer -Influence on the Tumor Microenvironment
Official title: Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Neoplasms
Recurrence Tumor
Keywords: head and neck squamous cell carcinoma
hyperthermia
hypoxia
18f-fluoromisonidazole
positron emission tomography
FMISO
PET
whole body hyperthermia
local recurrence
lymph node recurrence
radiochemotherapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Erwin Braun foundation
First posted: 2018-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase I feasibility study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: feasibility of whole body hyperthermia as adjunct to radiochemotherapy
timeFrame: within 6 weeks of treatment with radiochemotherapy
Secondary outcomes:
measure: Reduction of positron emission tomography (PET) measured hypoxia
timeFrame: 1 year (recruitment) plus additional 2 weeks (evaluation of PET parameter)
measure: magnetic resonance imaging (MRI) measured perfusion changes
timeFrame: 1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter)
measure: Patient reported quality of life (head and neck cancer specific quality of life)
timeFrame: 3 years (i.e. recruitment plus two years of follow-up)
measure: Patient reported quality of life (general quality of life)
timeFrame: 3 years (i.e. recruitment plus two years of follow-up)
measure: Local control after 2 years of follow-up
timeFrame: 3 years (1 year recruitment, 2 years follow-up)
measure: Loco-regional control after 2 years of follow-up
timeFrame: 3 years (1 year recruitment, 2 years follow-up)
measure: Overall survival after 2 years of follow-up
timeFrame: 3 years (1 year recruitment, 2 years follow-up)
measure: Freedom from distant metastases after 2 years of follow-up
timeFrame: 3 years (1 year recruitment, 2 years follow-up)
measure: Tumor response
timeFrame: 1 year (recruitment) and 3 months (follow-up)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Radioonkologie und Strahlentherapie
Study officials:
affiliation: Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany
name: Sebastian Zschaeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zschaeck S, Weingartner J, Ghadjar P, Wust P, Mehrhof F, Kalinauskaite G, Ehrhardt VH, Hartmann V, Tinhofer I, Heiland M, Coordes A, Kofla G, Budach V, Stromberger C, Beck M. Fever range whole body hyperthermia for re-irradiation of head and neck squamous cell carcinomas: Final results of a prospective study. Oral Oncol. 2021 May;116:105240. doi: 10.1016/j.oraloncology.2021.105240. Epub 2021 Feb 21.