Skin Cancer and Hyperthermia and Radiotherapy
Recruiting · NCT06384053 · Interventional (participants receive a specific treatment) · Lead sponsor: Kantonsspital Winterthur KSW
View the official record on ClinicalTrials.gov →Interventions studied
Radiotherapy (RT)Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined
What this trial is about
The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy (RT) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (NMSC).
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Personally signed and dated written informed consent
- Histologically confirmed invasive non-melanoma skin cancer (NMSC), including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of any differentiation
- ≥ T2 (TNM Classification 8th Edition)
- Tumor thickness up to 2cm (Maximum Depth invasion and/or exophytic growth, measured on pathology report or imaging)
- Local recurrence allowed, if primary treatment longer ago than 6 months (after primary treatment other than radiotherapy (RT))
- Age ≥ 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2, with a life expectancy of more than 6 months
- Presentation at the Swiss Hyperthermia Network (SHN) tumor conference mandatory
Exclusion criteria
- Other histology than BCC or SCC
- T1 tumor and/or N+ (according to TNM classification 8th edition)
- Tumors after resection (R1 or R2 as well as adjuvant indication)
- Tumor invasion into critical areas
- Several lesions exceeding the capacity of one treatment/radiation field (multiple lesions within one treatment field are acceptable)
- Previous (one month) or concurrent Chemo- or Immunotherapy
- Patients with connective tissue disorders (e.g. Sclerodermia, Lupus erythematodes)
- Lesions inside or in proximity (within 3cm) previously irradiated area
- Medical immunosuppression
- wIRA-specific exclusion criteria
- Tattoos in irradiated area
- Increased photosensitivity (either due to simultaneous treatment with photosensitivity-enhancing medications or conditions such as porphyria)
Where it is running
4 locations listed.
- Lindenhofgruppe - Bern, Switzerland
- Luzerner Kantonsspital - Lucerne, Switzerland
- Kantonsspital Aarau - Aarau, Canton of Aargau, Switzerland
- Kantonsspital Winterthur - Winterthur, Canton of Zurich, Switzerland