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| Name | Class |
|---|---|
| Erwin Braun foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Additional application of weekly moderate whole-body hyperthermia concurrent to re-irradiation plus chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate whole body hyperthermia using water-filtered IR-A-radiation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 6 weeks of treatment with radiochemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year (recruitment) plus additional 2 weeks (evaluation of PET parameter) |
| magnetic resonance imaging (MRI) measured perfusion changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Zschaeck, MD | Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Radioonkologie und Strahlentherapie | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33626457 | Derived | 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. |
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pseudonymized data may be shared upon reasonable request if accepted by all participating ethical commissions
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 12, 2021 | |
| Reset | Jun 7, 2021 |
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Phase I feasibility study
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|
measured before treatment and at the end of week 2 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 1 year (recruitment) and 3 months (follow-up) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2021 | Jun 7, 2021 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D012008 | Recurrence |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D000084462 | Hyperthermia |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D012818 | Signs and Symptoms, Respiratory |
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