Thermotherapy in Addition to SOC Palliative Radiotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London

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

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

King's College London

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator