RECRUITINGINTERVENTIONAL
Skin Cancer and Hyperthermia and Radiotherapy
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- Personally signed and dated written willing to sign a consent form
- diagnosed by tissue sample (biopsy-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
Who Should NOT Join This Trial:
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
COMBINATION_PRODUCT
Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined
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.
RADIATION
Radiotherapy (RT)
Radiotherapy is applied.
Locations (4)
Kantonsspital Aarau
Aarau, Canton of Aargau, Switzerland
Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland
Lindenhofgruppe
Bern, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland