Head and Neck Neoplasms Clinical Trial
— GKH-TMMOfficial title:
Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.
NCT number | NCT03547388 |
Other study ID # | EA2/047/18 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | May 4, 2020 |
Verified date | May 2020 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 4, 2020 |
Est. primary completion date | May 4, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinik für Radioonkologie und Strahlentherapie | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | Erwin Braun foundation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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) | |
Secondary | magnetic resonance imaging (MRI) measured perfusion changes | measured before treatment and at the end of week 2 | 1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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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