NCT06384053Recruiting
Skin Cancer and Hyperthermia and Radiotherapy
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 15 Apr 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Kantonsspital Winterthur KSW
- Diseases
- Melanoma
- NCT number
- NCT06384053
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jan 2025 to the primary completion date, 1 Jul 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Tumors after resection (R1 or R2 as well as adjuvant indication)
- 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
- Lesions inside or in proximity (within 3cm) previously irradiated area
- wIRA-specific exclusion criteria
- Tattoos in irradiated area
- Increased photosensitivity (either due to simultaneous treatment with photosensitivity-enhancing medications or conditions such as porphyria)
Other illness
- Patients with connective tissue disorders (e.g. Sclerodermia, Lupus erythematodes)
Other
- Other histology than BCC or SCC
- T1 tumor and/or N+ (according to TNM classification 8th edition)
- Tumor invasion into critical areas
- Medical immunosuppression
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kantonsspital Aarau Coordinator of this site? Confirm its status | Aarau | Switzerland | Recruiting |
| Lindenhofgruppe Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Luzerner Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Recruiting |
| Kantonsspital Winterthur Coordinator of this site? Confirm its status | Winterthur | Switzerland | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.