Clinical trial NCT06659146: Thermotherapy in Addition to SOC Palliative Radiotherapy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Cutaneous Squamous Cell Carcinoma
Breast Cancer Recurrent
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2024-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study involves delivering heat treatment (thermotherapy or hyperthermia) in combination with radiotherapy (RT). Heat therapy (HT) is defined as an elevation of tissue or body temperature, and it can be used as a cancer treatment method due to the profound effect that heat has on cells. In this study, HT will be used alongside RT to enhance the effect of RT. Treatment will involve heating the tumour and the surrounding area using a specialised machine, a water-filtered infra-red-A (wIRA) superficial HT machine. HT has been shown to make cancer cells more sensitive to other cancer treatments such as RT, chemotherapy and immunotherapy and is currently in use in multiple cancer centres across Europe and Switzerland but not in the UK.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Real-world implementation
timeFrame: 24 months
Secondary outcomes:
measure: Best objective response rate
timeFrame: 24 months
measure: Safety profile and toxicities
timeFrame: 24 months
measure: Median progression-free survival (PFS) and median overall survival (OS)
timeFrame: 24 months
measure: Duration of objective response and locoregional control rates at 6 and 12 months
timeFrame: 24 months
measure: Quality of life (QoL)
timeFrame: 24 months
measure: Efficacy between the lesion(s) treated with radiotherapy with hyperthermia with the lesion(s) treated with radiotherapy alone
timeFrame: 24 months
measure: Comparison of clinical outcomes with historical control
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St. Thomas NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's Cancer Centre
Study officials:
affiliation: Clinical reader and honorary NHS consultant in clinical oncology
name: Anthony Kong
role: PRINCIPAL_INVESTIGATOR
References: