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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547388
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Erwin Braun foundation
Information provided by (Responsible Party):
Sebastian Zschaeck, Charite University, Berlin, Germany

Study Description
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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
Head and Neck Neoplasms Recurrence Tumor Device: Moderate whole body hyperthermia using water-filtered IR-A-radiation 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase I feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : May 4, 2020
Actual Study Completion Date : May 4, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: hypoxia imaging using 18f-fluoromisonidazole before radiochemotherapy and during second week of treatment


Outcome Measures
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Primary Outcome Measures :
  1. feasibility of whole body hyperthermia as adjunct to radiochemotherapy [ Time Frame: 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 :
  1. Reduction of positron emission tomography (PET) measured hypoxia [ Time Frame: 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

  2. magnetic resonance imaging (MRI) measured perfusion changes [ Time Frame: 1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter) ]
    measured before treatment and at the end of week 2

  3. Patient reported quality of life (head and neck cancer specific quality of life) [ Time Frame: 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.

  4. Patient reported quality of life (general quality of life) [ Time Frame: 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.

  5. Local control after 2 years of follow-up [ Time Frame: 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.

  6. Loco-regional control after 2 years of follow-up [ Time Frame: 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.

  7. Overall survival after 2 years of follow-up [ Time Frame: 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.

  8. Freedom from distant metastases after 2 years of follow-up [ Time Frame: 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.

  9. Tumor response [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547388


Locations
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Germany
Klinik für Radioonkologie und Strahlentherapie
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Erwin Braun foundation
Investigators
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Principal Investigator: Sebastian Zschaeck, MD Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sebastian Zschaeck, MD, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03547388    
Other Study ID Numbers: EA2/047/18
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: pseudonymized data may be shared upon reasonable request if accepted by all participating ethical commissions

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sebastian Zschaeck, Charite University, Berlin, Germany:
head and neck squamous cell carcinoma
hyperthermia
hypoxia
18f-fluoromisonidazole
positron emission tomography
FMISO
 PET
whole body hyperthermia
local recurrence
lymph node recurrence
radiochemotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Recurrence
Hyperthermia
Disease Attributes
Pathologic Processes
 Neoplasms by Site
Neoplasms
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries