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Recruiting

Skin Cancer and Hyperthermia and Radiotherapy

NCT06384053 · Kantonsspital Winterthur KSW
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Official title
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
About this study
The SAHARA Trial is investigating if adding hyperthermia to radiotherapy (RT) can enhance treatment outcomes by making cancer cells more sensitive to radiation, thus requiring lower doses and potentially reducing side effects. The trial compares high-dose RT alone with de-escalated RT plus hyperthermia. The aim is to demonstrate that the combination is non-inferior to standard RT in treating non-melanoma skin cancer (NMSC). The trial is designed for elderly people of 65 years or older.
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)
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: none
Age groups: older_adult
Timeline
Starts: 2025-01-01
Estimated completion: 2028-07-01
Last updated: 2025-06-15
Interventions
Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combinedRadiation: Radiotherapy (RT)
Primary outcomes
  • Local control (Within two years post-treatment initiation.)
Sponsor
Kantonsspital Winterthur KSW · other
With: Luzerner Kantonsspital, Lindenhofgruppe AG, Kantonsspital Aarau
Contacts & investigators
ContactNidar Batifi, MSc · contact · sahara-team@ksw.ch · +41522665361
ContactDaniel Zwahlen, Prof. Dr. med. · contact · radioonkologie@ksw.ch · +4152 266 26 53
InvestigatorWinfried Arnold, Dr.med.univ.(A) · principal_investigator, Luzerner Kantonsspital
InvestigatorMaximilian Sturz, Dr.med. · principal_investigator, Luzerner Kantonsspital
All locations (4)
Kantonsspital AarauRecruiting
Aarau, Canton of Aargau, Switzerland
Kantonsspital WinterthurRecruiting
Winterthur, Canton of Zurich, Switzerland
LindenhofgruppeRecruiting
Bern, Switzerland
Luzerner KantonsspitalRecruiting
Lucerne, Switzerland
Skin Cancer and Hyperthermia and Radiotherapy · TrialPath