Clinical trial · Interventional
Thermotherapy in Addition to SOC Palliative Radiotherapy
Prospective Study to Assess the Real-world Implementation of Thermotherapy Using wIRA (Water-filtered Infrared A Superficial Hyperthermia) in Addition to Standard of Care (SOC) Palliative Radiotherapy (RT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Recurrent | — | UNRESOLVED | — |
| Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Superficial hyperthermia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Head and neck squamous cell carcinoma
- description
- 1\) HNSCC i) Inoperable/incurable or recurrent/metastatic HNSCC with no previous radiotherapy treatment ii) Inoperable/incurable or recurrent/metastatic HNSCC with previous radiotherapy treatment (re-irradiation)
- interventionNames
- Device: Superficial hyperthermia
- type
- EXPERIMENTAL
- label
- Cutaneous squamous cell carcinoma
- description
- 2\) cSCC i) Inoperable/incurable or recurrent/metastatic cSCC with no previous radiotherapy treatment ii) Inoperable/incurable or recurrent/metastatic cSCC with previous radiotherapy treatment (re-irradiation)
- interventionNames
- Device: Superficial hyperthermia
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available