Thermotherapy in Addition to SOC Palliative Radiotherapy

Summary

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

Inclusion Criteria:

1. 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
2. Patient undergoing standard of care palliative radiotherapy (suitable with the pre-specified dose and fractionation in the protocol
3. Aged ≥18 years old
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
5. Patient with capacity to consent

Exclusion Criteria:

1. No superficial tumour lesion or lymph node that is suitable for hydrosun® TWH1500 treatment.
2. Patients are not suitable for one of the pre-specified palliative radiotherapy dose and fractionation
3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Conditions5

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