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Completed

NCT Number: NCT03547388

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

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.

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Key information

Conditions

Head and Neck Neoplasms Body Temperature Changes Carcinoma Carcinoma, Squamous Cell Disease Attributes Heat Stress Disorders Hyperthermia Hypoxia Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrence Tumor Signs and Symptoms Signs and Symptoms, Respiratory Squamous Cell Carcinoma of Head and Neck Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Klinik für Radioonkologie und Strahlentherapie

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate whole body hyperthermia using water-filtered IR-A-radiation

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Erwin Braun foundation

Registry information

Official study title

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

Acronym: GKH-TMM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 6, 2018
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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