Head and Neck NeoplasmsPhase 1GKH-TMMNCT03547388
Moderate Whole Body Hyperthermia for Patients Undergoing Re-irradiation for Head and Neck Cancer -Influence on the Tumor Microenvironment
A Phase 1 study testing Moderate whole body hyperthermia using water-filtered IR-A-radiation in people with Head and Neck Neoplasms and Recurrence Tumor, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Neoplasms, Recurrence Tumor
- What is being tested?
- Moderate whole body hyperthermia using water-filtered IR-A-radiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 4 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.
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.
Read the 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.
- Conditions
- Head and Neck Neoplasms, Recurrence Tumor
- Being tested
- Moderate whole body hyperthermia using water-filtered IR-A-radiation
- 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
- Medical subject headings
- Head and Neck Neoplasms, Recurrence, Squamous Cell Carcinoma of Head and Neck, Hyperthermia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate whole body hyperthermia using water-filtered IR-A-radiationDevice
Also called hypoxia imaging using 18f-fluoromisonidazole before radiochemotherapy and during second week of treatment
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
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Additional application of weekly moderate whole-body hyperthermia concurrent to re-irradiation plus chemotherapy Receives: Device: Moderate whole body hyperthermia using water-filtered IR-A-radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 6 weeks of treatment with radiochemotherapy
Secondary outcomes (9)
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
Measured: 1 year (recruitment) plus additional 2 weeks (evaluation of PET parameter)
magnetic resonance imaging (MRI) measured perfusion changes
measured before treatment and at the end of week 2
Measured: 1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter)
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.
Measured: 3 years (i.e. recruitment plus two years of follow-up)
Patient reported quality of life (general quality of life)
measured by questionnaires according to EORTC (C30) and Transformation of absolute values to percentual values.
Measured: 3 years (i.e. recruitment plus two years of follow-up)
Local control after 2 years of follow-up
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
Measured: 3 years (1 year recruitment, 2 years follow-up)
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.
Measured: 3 years (1 year recruitment, 2 years follow-up)
Overall survival after 2 years of follow-up
From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.
Measured: 3 years (1 year recruitment, 2 years follow-up)
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.
Measured: 3 years (1 year recruitment, 2 years follow-up)
Tumor response
Response of the irradiated tumor 3 months after end of treatment according to recist criteria
Measured: 1 year (recruitment) and 3 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Jul 2018
- Primary completion4 May 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I feasibility study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Erwin Braun foundation
- Responsible party
- Principal investigator, Sebastian Zschaeck, Charite University, Berlin, Germany
- Investigators
- Sebastian Zschaeck, MD, Principal investigator, Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547388
- Sponsor's protocol ID
- EA2/047/18
- Acronym
- GKH-TMM
- Status last verified
- May 2020
- First submitted
- 27 Mar 2018
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: pseudonymized data may be shared upon reasonable request if accepted by all participating ethical commissions
Publications
Zschaeck S, Weingartner J, Ghadjar P, Wust P, Mehrhof F, Kalinauskaite G, Ehrhardt VH, Hartmann V, Tinhofer I, Heiland M, Coordes A, Kofla G, Budach V, Stromberger C, Beck M. Fever range whole body hyperthermia for re-irradiation of head and neck squamous cell carcinomas: Final results of a prospective study. Oral Oncol. 2021 May;116:105240. doi: 10.1016/j.oraloncology.2021.105240. Epub 2021 Feb 21.
PubMed 33626457
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.
- ClinicalTrials.gov ID
- NCT03547388
- Acronym / sponsor ID
- GKH-TMM / EA2/047/18
- Conditions
- Head and Neck Neoplasms, Recurrence Tumor
- Keywords
- head and neck squamous cell carcinoma, hyperthermia, hypoxia, 18f-fluoromisonidazole, positron emission tomography, FMISO, PET, whole body hyperthermia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Erwin Braun foundation
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I feasibility study
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Moderate whole body hyperthermia using water-filtered IR-A-radiationAdditional application of weekly moderate whole-body hyperthermia concurrent to re-irradiation plus chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate whole body hyperthermia using water-filtered IR-A-radiationAlso: hypoxia imaging using 18f-fluoromisonidazole before radiochemotherapy and during second week of treatmentfour 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 | Device | Single Arm |
Primary outcome
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
9 secondary outcomes
Reduction of positron emission tomography (PET) measured hypoxia
Time frame: 1 year (recruitment) plus additional 2 weeks (evaluation of PET parameter)
magnetic resonance imaging (MRI) measured perfusion changes
Time frame: 1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter)
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)
Patient reported quality of life (general quality of life)
Time frame: 3 years (i.e. recruitment plus two years of follow-up)
Local control after 2 years of follow-up
Time frame: 3 years (1 year recruitment, 2 years follow-up)
Loco-regional control after 2 years of follow-up
Time frame: 3 years (1 year recruitment, 2 years follow-up)
Overall survival after 2 years of follow-up
Time frame: 3 years (1 year recruitment, 2 years follow-up)
Freedom from distant metastases after 2 years of follow-up
Time frame: 3 years (1 year recruitment, 2 years follow-up)
Tumor response
Time frame: 1 year (recruitment) and 3 months (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Derived from this study: PubMed 33626457Zschaeck S, Weingartner J, Ghadjar P, Wust P, Mehrhof F, Kalinauskaite G, Ehrhardt VH, Hartmann V, Tinhofer I, Heiland M, Coordes A, Kofla G, Budach V, Stromberger C, Beck M. Fever range whole body hyperthermia for re-irradiation of head and neck squamous cell carcinomas: Final results of a prospective study. Oral Oncol. 2021 May;116:105240. doi: 10.1016/j.oraloncology.2021.105240. Epub 2021 Feb 21.
- Individual participant dataSharing planned: Undecided. pseudonymized data may be shared upon reasonable request if accepted by all participating ethical commissions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Zschaeck, MD principal investigator
Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moderate whole body hyperthermia using water-filtered IR-A-radiation in people with Head and Neck Neoplasms and Recurrence Tumor, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of whole body hyperthermia as adjunct to radiochemotherapy (time frame: within 6 weeks of treatment with radiochemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03547388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.