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Skin Cancer and Hyperthermia and Radiotherapy

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About this study

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).

Condition
Basal Cell Carcinoma, Squamous Cell Carcinoma Skin, Non-melanoma Skin Cancer
Tested
Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined, Radiotherapy (RT)
Sponsor
Kantonsspital Winterthur KSW

Who can join

Age
65 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 65 years
  • Study condition: Basal Cell Carcinoma, Squamous Cell Carcinoma Skin, Non-melanoma Skin Cancer
  • 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 12

  • 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

4 sites, 4 recruiting

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Recruiting

Lindenhofgruppe

Bern, Switzerland

Recruiting

Luzerner Kantonsspital

Lucerne, Switzerland

Recruiting

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.