Adding water-filtered infrared-A heat to radiotherapy for non-melanoma skin cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.