Head and Neck Neoplasms, Recurrence Tumor
Conditions
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
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.
Interventions
DEVICEModerate 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
Sponsors
Erwin Braun foundation
Charite University, Berlin, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase I feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
Countries
Germany
Outcome results
None listed