GKH-TMM: Moderate Whole Body Hyperthermia for Patients Undergoing Re-irradiation for Head and Neck Cancer -Influence on the Tumor Microenvironment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm Additional application of weekly moderate whole-body hyperthermia concurrent to re-irradiation plus chemotherapy |
Device: Moderate whole body hyperthermia using water-filtered IR-A-radiation
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
Other Names:
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Outcome Measures
Primary Outcome Measures
- feasibility of whole body hyperthermia as adjunct to radiochemotherapy [within 6 weeks of treatment with radiochemotherapy]
feasibility is defined as at least 4 cycles of whole body hyperthermia in 80% of patients
Secondary Outcome Measures
- Reduction of positron emission tomography (PET) measured hypoxia [1 year (recruitment) plus additional 2 weeks (evaluation of PET parameter)]
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
- magnetic resonance imaging (MRI) measured perfusion changes [1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter)]
measured before treatment and at the end of week 2
- Patient reported quality of life (head and neck cancer specific quality of life) [3 years (i.e. recruitment plus two years of follow-up)]
measured by questionnaires according to EORTC (H&N35) and Transformation of absolute values to percentual values.
- Patient reported quality of life (general quality of life) [3 years (i.e. recruitment plus two years of follow-up)]
measured by questionnaires according to EORTC (C30) and Transformation of absolute values to percentual values.
- Local control after 2 years of follow-up [3 years (1 year recruitment, 2 years follow-up)]
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
- Loco-regional control after 2 years of follow-up [3 years (1 year recruitment, 2 years follow-up)]
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
- Overall survival after 2 years of follow-up [3 years (1 year recruitment, 2 years follow-up)]
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
- Freedom from distant metastases after 2 years of follow-up [3 years (1 year recruitment, 2 years follow-up)]
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
- Tumor response [1 year (recruitment) and 3 months (follow-up)]
Response of the irradiated tumor 3 months after end of treatment according to recist criteria
Eligibility Criteria
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
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time interval of 6 months to 5 years after completion of last radiotherapy of the head and neck region
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Completed staging examinations, preferentially 18f-fluorodeoxyglucose (FDG) PET of the whole body
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general health condition according to ECOG status of 0,1 or 2
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age between 18 and 75 years
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written informed consent
Exclusion Criteria:
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HPV associated primary tumor or recurrent tumor
-
recurrence more than 5 years after end of previous radiotherapy
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Any medical circumstances impeding the application of radiotherapy, concomitant chemotherapy or whole body hyperthermia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinik für Radioonkologie und Strahlentherapie | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- Erwin Braun foundation
Investigators
- Principal Investigator: Sebastian Zschaeck, MD, Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EA2/047/18