Skin Cancer and Hyperthermia and Radiotherapy
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
Kantonsspital Winterthur KSW
100 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria11
- 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
- Tattoos in irradiated area
- Increased photosensitivity (either due to simultaneous treatment with photosensitivity-enhancing medications or conditions such as porphyria)
Interventions
The wIRA device applies hyperthermia by heating the treatment area (with maximum surface temperature set to 43° C), aiming to make cancer cells more sensitive to radiation therapy for non-melanoma skin cancer combined with radiotherapy.
Radiotherapy is applied.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06384053