Head and neck cancer, Head and neck carcinoma, Head and neck squamous cell carcinoma, Laryngeal cancer, Laryngeal carcinoma, Laryngeal squamous cell carcinoma, Pharyngeal cancer, Pharyngeal carcinoma, Pharyngeal squamous cell carcinoma, Oropharyngeal cancer, Oropharyngeal carcinoma, Oropharyngeal squamous cell carcinoma, Oral cavity cancer, Oral cancer, Oral cavity carcinoma, Oral squamous cell carcinoma Head and neck cancer, Throat cancer, Mouth cancer
Conditions
Interventions
The interventional treatment is thermotherapy treatment applied with the HyperCollar3D. The thermotherapy treatment will take place once per week, during the radio(chemo)therapy course. Thermotherapy
1. 75 W/kg 
2. 100 W/kg 
3. 125 W/kg4. 150 W/kg 
Thermotherapy preparations take place in the radiotherapy department. An individualized head cushion and nose bridge fixation are made to be able to fixate the head, but leaving as much space as possi
Before each thermotherapy treatment, the placement of thermometers is determined, which may be inside the mouth or on the skin of the neck and cheeks. If the patient
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >= 18 years WHO 0-1 Maximal mouth opening of >= 40 mm for woman and >= 45mm for man, before treatment Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx proven by cytology/histology Locally-advanced disease (stage III-IV) Curative intend treatment with radio(chemo)therapy in the primary setting Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician Written informed consent
Exclusion criteria
Exclusion criteria: Patients previously treated by radiation on the same target volume Any condition or circumstance potentially hampering compliance with the follow-up schedule Patients having pacemakers or clustered metal markers that could interfere with the treatment, based on the treatment planning (from a total length >2 cm of metal objects in direct contact). Tumor location caudal to a tracheostomy (this prevents penetration of the microwaves to the tumor). Anatomical boundaries of the shoulders prohibiting positioning of the applicator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of thermotherapy in combination with standard chemoradiotherapy in LAHNSCC patients. Safety is assessed by the occurrence of dose-limiting toxicities and tolerability is assessed by the ability of patients to complete planned thermotherapy treatments, in order to determine the RP2D. DLTs, along with tolerability criteria, will guide the dose escalation or de-escalation decisions. Dose-limiting toxicity (DLT) of trismus will be objectively assessed by measuring mouth opening using a caliper according to a standardized protocol. Patients will be asked to open their mouths as wide as possible, and the distance between the incisal edges of teeth 11 and 41 (or from the dental prosthesis) will be measured. For edentulous patients without a dental prosthesis, the alveolar ridge of the lower and/or upper jaw (region 11 and 41) will be used. Maximal mouth opening will be measured at baseline, after each thermotherapy fraction, and at regular follow-up visits (end of radiotherapy, 6, 12, and 24 weeks post-radiotherapy). Additionally, DLTs will be closely monitored at the same time points. Tolerability of the thermotherapy dose is defined as the ability of the patient to successfully complete most thermotherapy fractions. When most patients have pain complaints or large discomfort, the thermotherapy dose level is not tolerable to endure and de-escalation will be necessary. The tolerability of a certain thermotherapy dose is determined on 3 different levels: On the level of individual thermotherapy fractions On the level of the individual patient, combining all thermotherapy fractions On the level of the dose level cohort, assessing all patients treated with that certain thermotherapy dose. Level 1 - An individual thermotherapy treatment takes 75 minutes. In case of pain or discomfort during the thermotherapy treatment, optimization of the thermotherapy treatment plan will take place in real-time/online, re | — |
Secondary
| Measure | Time frame |
|---|---|
| Registration of tolerability and DLT in (elderly) LAHNSCC patients receiving thermotherapy in combination with radiotherapy alone. Local control, 3-years Progression Free Survival and 3-years overall survival. System performance: treatment session characteristics, occurrence of technical issues requiring treatment adaptation, reflection measurements. | — |
Countries
Netherlands
Contacts
Public ContactT.L. Coenraad
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed