Skin cancer treatment with heat treatment (hyperthermia) and radiation therapy – SAHARA, an open-label, two-arm, randomized, controlled Phase II study.
Descrizione riassuntiva dello studio
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)
Intervento studiato
non-melanoma skin cancer (NMSC), white skin cancer.
(BASEC)
Malattie studiate
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)
Criteri di esclusione
(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)
Luogo dello studio
Aarau, Berna, Luzern, Winterthur
(BASEC)
Sponsor
Prof. Dr. med. Daniel R. Zwahlen
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Nidar Batifi
0522665361
nidar.batifi@clutterksw.chKantonsspital Winterthur
(BASEC)
Informazioni generali
Luzerner Kantonsspital,Luzerner Kantonsspital,
0522665361;
study-coordination-radiotherapy@ksw.ch(ICTRP)
Informazioni generali
Luzerner KantonsspitalLuzerner Kantonsspital
+41522665361
sahara-team@ksw.ch(ICTRP)
Informazioni scientifiche
Luzerner Kantonsspital,Luzerner Kantonsspital,
0522665361;
study-coordination-radiotherapy@ksw.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
28.06.2024
(BASEC)
ID di studio ICTRP
NCT06384053 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Hautkrebsbehandlung mit Wärmebehandlung (Hyperthermie) und Strahlentherapie – SAHARA, eine offene, zwei-armige, zufällig zugewiesene, kontrollierte Phase II Studie. (BASEC)
Titolo accademico
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial (ICTRP)
Titolo pubblico
Skin Cancer and Hyperthermia and Radiotherapy (ICTRP)
Malattie studiate
Basal Cell CarcinomaSquamous Cell Carcinoma SkinNon-melanoma Skin Cancer
(ICTRP)
Intervento studiato
Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combinedRadiation: Radiotherapy (RT)
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Local control
(ICTRP)
Analysis;Late toxicities;Quality of life assessment
(ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Luzerner Kantonsspital;Lindenhofgruppe AG;Kantonsspital Aarau (ICTRP)
Contatti aggiuntivi
Maximilian Sturz, MD;Arnold Winfried, MD;Nidar Batifi, MSc;Winfried Arnold, MD, study-coordination-radiotherapy@ksw.ch, 0522665361;, Luzerner Kantonsspital,Luzerner Kantonsspital, (ICTRP)
ID secondari
SAHARA Trial (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06384053 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile