Clinical trial phase I with thermotherapy to start

Clinical trial phase I with thermotherapy to start

A critical milestone for the evidence base of thermotherapy has been achieved with the start of the TANCA phase I trial in ErasmusMC. By granting funding to this trial, KWF (Dutch Cancer Foundation) shows its commitment and support for this trial. We cannot be grateful enough as when this proves successful, this will give patients with Head and Neck cancer better chances to cure and to improve their Quality of Life. Dr. Michiel Kroesen and his team expect to include the first patients in Q1 2024 on the existing prototype that is already in ErasmusMC. The trial data give input on the safety of the prototype and treatment which can be used later to demonstrate technical equivalence with the FocusCollar.

Big congratulations to the PI of the trial dr. Michiel Kroesen, his clinical team and the inventors of the HyperCollar3D device Maarten Paulides and Gerard van Rhoon!

TANCA trial 

Thermotherapy is the elevation of tissue temperature to fever-range levels, 40-44 degrees Celsius. Thermotherapy in combination with radiotherapy, so-called thermoradiotherapy, enhances the efficacy of radiotherapy in various tumor sites. In head and neck squamous cell carcinoma (HNSCC) patients, the maximal tolerable dose (MTD) of thermoradiotherapy has not been determined yet. The hypothesis that there is an MTD dose of thermoradiotherapy in HNSCC patients that is tolerable and does not result in increased late side effects compared to radiotherapy alone in patients with head and neck cancer.

The trial design is a phase I dose finding intervention study using a Time-to-Event Bayesian Optimal Interval (TiTE-BOIN).

The study population is patients with locally advanced oropharyngeal, hypopharyngeal and laryngeal cancer indicated for primary radiotherapy as monotherapy with curative intent.

The selected patients will receive weekly thermotherapy treatments (minimal 4 - maximal 7) in addition to standard-of-care radiotherapy.

The primary endpoint is identification of the Maximum Tolerable Dose. Secondary endpoints are local control, Disease Free Survival and Overall Survival, acute- and late toxicity, Patient related outcome measurements.