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Clinical Trials in Switzerland / NCT06384053
Recruiting Not applicable

Skin Cancer and Hyperthermia and Radiotherapy

NCT06384053 · tracked via the Priya Life Science Switzerland tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2025-06-15

Condition(s) studied

Basal Cell CarcinomaSquamous Cell Carcinoma SkinNon-melanoma Skin Cancer

Investigational drug(s) / intervention(s)

Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combinedRadiotherapy (RT)

Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined: The wIRA device applies hyperthermia by heating the treatment area (with maximum surface temperature set to 43° C), aiming to make cancer cells more sensitive to radiation therapy for non-melanoma skin cancer combined with radiotherapy.

Radiotherapy (RT): Radiotherapy is applied.

Study summary

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).

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Kantonsspital Aarau Aarau Canton of Aargau Recruiting
Kantonsspital Winterthur Winterthur Canton of Zurich Recruiting
Lindenhofgruppe Bern Switzerland Recruiting
Luzerner Kantonsspital Lucerne Switzerland Recruiting

More Kantonsspital Winterthur KSW trials in Switzerland

Other trials for the same condition

FLASH Radiotherapy for Skin Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06384053 on ClinicalTrials.gov ↗ ← All trials in Switzerland