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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Patient with capacity to consent

Locations
Other Locations
United Kingdom
Guy's and St. Thomas NHS Foundation Trust
RECRUITING
London
Guy's Cancer Centre
RECRUITING
London
Contact Information
Primary
Anthony Kong
Anthony.Kong@kcl.ac.uk
44+2078486004
Backup
Ifigenia Vasiliadou
Ifigenia.1.Vasiliadou@kcl.ac.uk
44+2078486004
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2027-10-13
Participants
Target number of participants: 60
Treatments
Experimental: Head and neck squamous cell carcinoma
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)
Experimental: Cutaneous squamous cell carcinoma
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)
Experimental: Locally recurrent breast cancer
3\) LRBC locally recurrent breast cancer with previous radiotherapy treatment (re-irradiation)
Sponsors
Leads: King's College London
Collaborators: Guy's and St Thomas' NHS Foundation Trust

This content was sourced from clinicaltrials.gov