NCT06384053 Skin Cancer and Hyperthermia and Radiotherapy
| NCT ID | NCT06384053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kantonsspital Winterthur KSW |
| Condition | Basal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-01-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Winfried Arnold, Dr.med.univ.(A)
PRINCIPAL INVESTIGATOR
Luzerner Kantonsspital
Frequently Asked Questions
Who can join the NCT06384053 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Basal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06384053 currently recruiting?
Yes, NCT06384053 is actively recruiting participants. Contact the research team at sahara-team@ksw.ch for enrollment information.
Where is the NCT06384053 trial being conducted?
This trial is being conducted at Aarau, Switzerland, Winterthur, Switzerland, Bern, Switzerland, Lucerne, Switzerland.
Who is sponsoring the NCT06384053 clinical trial?
NCT06384053 is sponsored by Kantonsspital Winterthur KSW. The principal investigator is Winfried Arnold, Dr.med.univ.(A) at Luzerner Kantonsspital. The trial plans to enroll 100 participants.