Moderate Whole Body Hyperthermia for Patients Undergoing Re-irradiation for Head and Neck Cancer -Influence on the Tumor Microenvironment

Head and Neck Neoplasms Clinical Trial

— GKH-TMM  

Official title:

Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547388
• Other study ID #: EA2/047/18
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2018
• Est. completion date: May 4, 2020

Study information

• Verified date: May 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Recurrence
• Recurrence Tumor

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik für Radioonkologie und Strahlentherapie	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Erwin Braun foundation

Country where clinical trial is conducted

Germany, 

Outcome

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)