This study aims to investigate the efficacy and safety profile of superficial hyperthermia (wIRA) in addition to standard of care (SOC) palliative radiotherapy in patients with inoperable/incurable locally advanced or recurrent/metastatic HNSCC or cutaneous SCC superficial tumours not suitable for radical treatment.
The investigators will assess the best objective response rate (ORR) of patients with Inoperable/incurable or recurrent/metastatic HNSCC or cSCC with superficial lesion(s) treated with the combination of superficial hyperthermia (wIRA) and palliative radiotherapy.
Patient with histologically confirmed incurable or inoperable cancers with disease [at least one superficial lesion(s) or lymph node(s)] suitable for hydrosun® TWH1500 treatment
Patient undergoing standard of care palliative radiotherapy (suitable with the pre-specified dose and fractionation in the protocol
Aged ≥18 years old
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
No superficial tumour lesion or lymph node that is suitable for hydrosun® TWH1500 treatment.
Patients are not suitable for one of the pre-specified palliative radiotherapy dose and fractionation
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Single group
Superficial hyperthermia
DeviceSuperficial hypothermia will be delivered using a CE-marked water-filtered infrared A (wIRA) machine (hydrosun® TWH1500)
Real-world implementation
The real-world implementation of superficial hyperthermia by assessing the number of patients treated by the intervention in order to determine whether this new treatment can be implemented in a NHS cancer centre
Best objective response rate
To assess the best objective response rate in patients receiving Thermotherapy (superficial hyperthermia) with palliative radiotherapy as part of the standard of care (SOC) by measuring the best objective response rate (ORR) (as determined by complete response rate and partial response rate according to RECIST 1.1)
Safety profile and toxicities
To determine the tolerability and safety profile of superficial hyperthermia in patients receiving SOC palliative radiotherapy by assessing the adverse events (CTCAE version 5.0) experienced by participants.
Median progression-free survival (PFS) and median overall survival (OS)
To evaluate the median progression-free survival (PFS) and median overall survival (OS) of patients. PFS= time from the start of treatment to progression or death; OS= time from the start of treatment to death. Patients not experiencing an event will be censored at the data last known to be alive and progression-free
Duration of objective response and locoregional control rates at 6 and 12 months
To assess the median duration of objective response and locoregional control rates at 6 and 12 months. The duration of response and disease control rates at 6, 12 and 24 months.
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King's College London
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator
