Clinical trial · Interventional
Moderate Whole Body Hyperthermia for Patients Undergoing Re-irradiation for Head and Neck Cancer -Influence on the Tumor Microenvironment
Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Recurrence Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moderate whole body hyperthermia using water-filtered IR-A-radiation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Additional application of weekly moderate whole-body hyperthermia concurrent to re-irradiation plus chemotherapy
- interventionNames
- Device: Moderate whole body hyperthermia using water-filtered IR-A-radiation
Primary outcomes (1)
- measure
- feasibility of whole body hyperthermia as adjunct to radiochemotherapy
- timeFrame
- within 6 weeks of treatment with radiochemotherapy
- description
- feasibility is defined as at least 4 cycles of whole body hyperthermia in 80% of patients
Secondary outcomes (9)
- measure
- Reduction of positron emission tomography (PET) measured hypoxia
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZschaeck 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. PMID 33626457