About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Superficial hyperthermia
Treatment groups
Sponsors and collaborators
King's College London
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator