Adding water-filtered infrared-A heat to radiotherapy for non-melanoma skin cancer
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
This trial tries adding water-filtered infrared-A (wIRA) heat to a lower-dose, accelerated radiotherapy schedule to see if it works as well as standard high-dose radiotherapy for people 65 or older with larger basal cell or squamous cell skin cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Kantonsspital Winterthur KSW Academic / other |
| Drugs / interventions | Immunotherapy, radiation |
| Locations | 4 sites (Aarau, Canton of Aargau and 3 other locations) |
| Trial ID | NCT06384053 on ClinicalTrials.gov |
What this trial studies
The SAHARA protocol compares standard hypofractionated high‑dose radiotherapy to a de‑escalated ultrahypofractionated accelerated radiotherapy schedule combined with water‑filtered infrared‑A (wIRA) hyperthermia in patients aged 65 and older with invasive non‑melanoma skin cancers. Eligible tumors are histologically confirmed BCC or SCC of at least T2 with tumor thickness up to 2 cm and ECOG performance status 0–2. The trial is designed as a non‑inferiority comparison of local control and treatment toxicity, using hyperthermia to sensitize tumor cells so radiation dose can be reduced. Treatments and hyperthermia sessions are delivered at participating Swiss cantonal hospitals with multidisciplinary case review by the Swiss Hyperthermia Network.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 or older with histologically confirmed invasive BCC or SCC (T2 or higher) with tumor thickness ≤2 cm, ECOG 0–2, life expectancy >6 months, and referral to the Swiss Hyperthermia Network tumor conference.
Not a fit: Patients with T1 tumors, nodal disease, non‑BCC/SCC histologies, tumors invading critical structures, recent resection requiring adjuvant therapy, or multiple lesions exceeding the trial cap are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could provide similar cancer control with lower radiation doses, reducing side effects and treatment burden for older patients.
How similar studies have performed: Hyperthermia has improved radiotherapy outcomes in some other tumor types, but combining wIRA hyperthermia with de‑escalated ultrahypofractionated radiotherapy for non‑melanoma skin cancer is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Aarau, Canton of Aargau and 3 other locations
- Kantonsspital Aarau — Aarau, Canton of Aargau, Switzerland (Recruiting)
- Kantonsspital Winterthur — Winterthur, Canton of Zurich, Switzerland (Recruiting)
- Lindenhofgruppe — Bern, Switzerland (Recruiting)
- Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Winfried Arnold, Dr.med.univ.(A) — Luzerner Kantonsspital
- Study coordinator: Nidar Batifi, MSc
- Email: sahara-team@ksw.ch
- Phone: +41522665361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.