NCT06384053Recruiting
Skin Cancer and Hyperthermia and Radiotherapy
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).
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)
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- No phase (N/A)
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- Kantonsspital Winterthur KSW(Other)
- Protocol no.
- SAHARA Trial
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma Skin, Non-melanoma Skin Cancer
- Interventions
- Combination product, Radiation
Treatments studied
- Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined
- Radiotherapy (RT)
Collaborators
Luzerner Kantonsspital, Lindenhofgruppe AG, Kantonsspital Aarau
Locations · 4
- Aarau, SwitzerlandKantonsspital AarauRecruiting at this site
- Winterthur, SwitzerlandKantonsspital WinterthurRecruiting at this site
- Bern, SwitzerlandLindenhofgruppeRecruiting at this site
- Lucerne, SwitzerlandLuzerner KantonsspitalRecruiting at this site
In total, worldwide, all 4 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: June 15, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.