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

NCT03547388 | Completed Phase 1

• 1 other identifier: EA2/047/18
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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; local recurrence; lymph node recurrence; radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Reduction of positron emission tomography (PET) measured hypoxia

  1 year (recruitment) plus additional 2 weeks (evaluation of PET parameter)

• magnetic resonance imaging (MRI) measured perfusion changes

  1 year (recruitment) plus additional 2 weeks (evaluation of MRI parameter)

• Patient reported quality of life (head and neck cancer specific quality of life)

  3 years (i.e. recruitment plus two years of follow-up)

• Patient reported quality of life (general quality of life)

  3 years (i.e. recruitment plus two years of follow-up)

• Local control after 2 years of follow-up

  3 years (1 year recruitment, 2 years follow-up)

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

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

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

Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Erwin Braun foundation: collaborator

Study Sites (1)

Klinik für Radioonkologie und Strahlentherapie

Berlin, 13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 33626457 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Recurrence; Squamous Cell Carcinoma of Head and Neck; Hyperthermia; Hypoxia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Signs and Symptoms, Respiratory

Study Officials

• Sebastian Zschaeck, MD

  Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: Phase I feasibility study

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: June 6, 2018
• Study Start: July 1, 2018
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

DE (1)