Thermotherapy in Addition to SOC Palliative Radiotherapy

NCT06659146 | Recruiting

• 1 other identifier: 327431
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma; Breast Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Real-world implementation

  The real-world implementation of superficial hyperthermia by assessing the number of patients treated by the intervention in order to determine whether this new treatment can be implemented in a NHS cancer centre

  24 months

Secondary Outcomes (7)

• Best objective response rate

  24 months

• Safety profile and toxicities

  24 months

• Median progression-free survival (PFS) and median overall survival (OS)

  24 months

• Duration of objective response and locoregional control rates at 6 and 12 months

  24 months

• Quality of life (QoL)

  24 months

Study Arms (3)

Head and neck squamous cell carcinoma

EXPERIMENTAL

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)

Device: Superficial hyperthermia

Cutaneous squamous cell carcinoma

EXPERIMENTAL

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)

Device: Superficial hyperthermia

Locally recurrent breast cancer

EXPERIMENTAL

3\) LRBC locally recurrent breast cancer with previous radiotherapy treatment (re-irradiation)

Device: Superficial hyperthermia

Interventions

Superficial hyperthermia DEVICE

Superficial hypothermia will be delivered using a CE-marked water-filtered infrared A (wIRA) machine (hydrosun® TWH1500)

Cutaneous squamous cell carcinoma; Head and neck squamous cell carcinoma; Locally recurrent breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (2)

Guy's and St. Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

Guy's Cancer Centre

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Anthony Kong

  Clinical reader and honorary NHS consultant in clinical oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Kong

CONTACT

44+2078486004; Anthony.Kong@kcl.ac.uk

Taylor McKenzie

CONTACT

44+2078486004; taylor.mckenzie@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: October 26, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will become available when the study begins and will be kept until the end of the study (2 years).
• Access Criteria: i) Researchers directly involved with the study. ii) The biobank team appointed to the study. iii) Researchers not part of the direct care team will have access through King's Health Partners research passports, if required.

Locations

GB (2)