Thermotherapy in Addition to SOC Palliative Radiotherapy
NCT ID: NCT06659146
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-10-14
2028-03-01
Brief Summary
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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.
Detailed Description
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Guy's Cancer centre is the first in the UK to acquire this CE marked superficial wIRA hyperthermia machine. Our aim is to assess the real-world implementation of HT using wIRA in combination with RT in patients with cancers that are suitable for superficial hyperthermia treatment.
This is a prospective study to assess the real-world implementation of superficial hyperthermia (wIRA) in combination with SOC palliative radiotherapy in cancer patients not suitable for radical treatment and have superficial lesion(s) suitable for wIRA treatment. Three cohorts of patients will be invited:
1. HNSCC (Head and neck squamous cell carcinoma) i) Inoperable/incurable locally advanced or recurrent/metastatic HNSCC with no previous radiotherapy treatment ii) Inoperable/incurable locally advanced or recurrent/metastatic HNSCC with previous radiotherapy treatment (re-irradiation)
2. cSCC (Cutaneous squamous cell carcinoma) in the head and neck region i) Inoperable/incurable locally advanced or recurrent/metastatic cSCC with no previous radiotherapy treatment ii) Inoperable/incurable locally advanced or recurrent/metastatic cSCC with previous radiotherapy treatment (re-irradiation) LRBC
3. LRBC (locally recurrent breast cancer) with previous radiotherapy treatment (re-irradiation)
All patients consenting to the study will be treated with HT. The patients will receive hyperthermia either once a week or twice a week using hydrosun® TWH1500 with palliative radiotherapy. The patients will receive hyperthermia treatment for 1 hour before going for palliative radiotherapy as per standard of care. For patients who will undergo 20Gy/5# over one week, they will receive hyperthermia two times per week during their treatment. For patients undergoing 27Gy/6#, they will receive hyperthermia once a week for three weeks during the course of palliative radiotherapy.
Patients will be assessed during their treatment for toxicities, and rate of adverse events will be assessed by CTCAE version 5.0. Follow-ups and assessment of response will be done as per standard of care.
When appropriate, we will aim to collect biological samples from each patient for translational research (see below) including archival tumour sample, fresh tumour biopsy or resection sample when available, blood samples at different time intervals before, during and after their treatments as well as saliva and mouth swab at the same time points when appropriate. The samples will be analysed to further assess the tumour microenvironment, the peripheral immune response and to identify predictors of treatment response.
Blood samples will be collected at baseline, pre-hyperthermia treatment, post-hyperthermia treatment, 6 weeks post radiotherapy, 12 weeks post radiotherapy and at disease progression. Other samples for translational research will be collected upon the clinician's discretion and up to a total of six times. As a standard of care, patient reported outcomes are routinely collected to assess toxicity to radiotherapy treatment, and this will continue to collect for this study.
Data will be collected on the number of patients treated, adverse events experienced, outcomes on survival and disease progression, comparison with treatment not involving HT, and exploratory outcomes using biological samples.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
Superficial hyperthermia
Superficial hypothermia will be delivered using a CE-marked water-filtered infrared A (wIRA) machine (hydrosun® TWH1500)
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)
Superficial hyperthermia
Superficial hypothermia will be delivered using a CE-marked water-filtered infrared A (wIRA) machine (hydrosun® TWH1500)
Locally recurrent breast cancer
3\) LRBC locally recurrent breast cancer with previous radiotherapy treatment (re-irradiation)
Superficial hyperthermia
Superficial hypothermia will be delivered using a CE-marked water-filtered infrared A (wIRA) machine (hydrosun® TWH1500)
Interventions
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Superficial hyperthermia
Superficial hypothermia will be delivered using a CE-marked water-filtered infrared A (wIRA) machine (hydrosun® TWH1500)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Anthony Kong
Role: PRINCIPAL_INVESTIGATOR
Clinical reader and honorary NHS consultant in clinical oncology
Locations
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Guy's and St. Thomas NHS Foundation Trust
London, , United Kingdom
Guy's Cancer Centre
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Anthony Kong
Role: primary
Anthony Kong, MBBS PhD
Role: primary
Christiana Cattaneo, PhD
Role: backup
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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327431
Identifier Type: -
Identifier Source: org_study_id