Skin cancer treatment with heat treatment (hyperthermia) and radiation therapy – SAHARA, an open-label, two-arm, randomized, controlled Phase II study.
Summary description of the study
In this study, participants are randomly assigned to two groups. This is an open investigation, meaning that both the participants and the treatment team know which treatment is being administered. Two treatment methods for non-melanoma skin cancer are being investigated. A "non-inferiority" approach is used to determine whether the combined therapy of radiation therapy and heat treatment (hyperthermia) is similarly effective as radiation therapy alone.
(BASEC)
Intervention under investigation
non-melanoma skin cancer (NMSC), white skin cancer.
(BASEC)
Disease under investigation
Non-melanoma skin cancer (white skin cancer).
(BASEC)
(1) Participants must sign a written informed consent.
(2) Participants must be over 65 years old.
(3) They must have invasive white skin cancer, such as basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), regardless of how well differentiated it is.
(4) The thickness or infiltration of the tumor into the skin and outward must not exceed 2 cm.
(BASEC)
Exclusion criteria
(1) Participants must not have received skin cancer treatment in the last 12 months, unless recommended for follow-up treatment.
(2) Participants must not have a severe connective tissue disease, such as scleroderma or systemic lupus erythematosus, at the same time.
(3) Individuals with medically induced immunosuppression are excluded from the study.
(BASEC)
Trial sites
Aarau, Bern, Luzern, Winterthur
(BASEC)
Sponsor
Prof. Dr. med. Daniel R. Zwahlen
(BASEC)
Contact
Contact Person Switzerland
Nidar Batifi
0522665361
nidar.batifi@clutterksw.chKantonsspital Winterthur
(BASEC)
General Information
Luzerner Kantonsspital,Luzerner Kantonsspital,
0522665361;
study-coordination-radiotherapy@ksw.ch(ICTRP)
General Information
Luzerner KantonsspitalLuzerner Kantonsspital
+41522665361
sahara-team@ksw.ch(ICTRP)
Scientific Information
Luzerner Kantonsspital,Luzerner Kantonsspital,
0522665361;
study-coordination-radiotherapy@ksw.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
28.06.2024
(BASEC)
ICTRP Trial ID
NCT06384053 (ICTRP)
Official title (approved by ethics committee)
Hautkrebsbehandlung mit Wärmebehandlung (Hyperthermie) und Strahlentherapie – SAHARA, eine offene, zwei-armige, zufällig zugewiesene, kontrollierte Phase II Studie. (BASEC)
Academic title
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial (ICTRP)
Public title
Skin Cancer and Hyperthermia and Radiotherapy (ICTRP)
Disease under investigation
Basal Cell CarcinomaSquamous Cell Carcinoma SkinNon-melanoma Skin Cancer
(ICTRP)
Intervention under investigation
Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combinedRadiation: Radiotherapy (RT)
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Inclusion/Exclusion 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)
(ICTRP)
not available
Primary and secondary end points
Local control
(ICTRP)
Analysis;Late toxicities;Quality of life assessment
(ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Luzerner Kantonsspital;Lindenhofgruppe AG;Kantonsspital Aarau (ICTRP)
Additional contacts
Maximilian Sturz, MD;Arnold Winfried, MD;Nidar Batifi, MSc;Winfried Arnold, MD, study-coordination-radiotherapy@ksw.ch, 0522665361;, Luzerner Kantonsspital,Luzerner Kantonsspital, (ICTRP)
Secondary trial IDs
SAHARA Trial (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06384053 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available