NCT06659146 Thermotherapy in Addition to SOC Palliative Radiotherapy
| NCT ID | NCT06659146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College London |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2028-03-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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.