Skin cancer treatment with heat treatment (hyperthermia) and radiation therapy – SAHARA, an open-label, two-arm, randomized, controlled Phase II study.
Zusammenfassung der Studie
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)
Untersuchte Intervention
non-melanoma skin cancer (NMSC), white skin cancer.
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
(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)
Studienstandort
Aarau, Bern, Luzern, Winterthur
(BASEC)
Sponsor
Prof. Dr. med. Daniel R. Zwahlen
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Nidar Batifi
0522665361
nidar.batifi@clutterksw.chKantonsspital Winterthur
(BASEC)
Allgemeine Auskünfte
Luzerner Kantonsspital,Luzerner Kantonsspital,
0522665361;
study-coordination-radiotherapy@ksw.ch(ICTRP)
Allgemeine Auskünfte
Luzerner KantonsspitalLuzerner Kantonsspital
+41522665361
sahara-team@ksw.ch(ICTRP)
Wissenschaftliche Auskünfte
Luzerner Kantonsspital,Luzerner Kantonsspital,
0522665361;
study-coordination-radiotherapy@ksw.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
28.06.2024
(BASEC)
ICTRP Studien-ID
NCT06384053 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Hautkrebsbehandlung mit Wärmebehandlung (Hyperthermie) und Strahlentherapie – SAHARA, eine offene, zwei-armige, zufällig zugewiesene, kontrollierte Phase II Studie. (BASEC)
Wissenschaftlicher Titel
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial (ICTRP)
Öffentlicher Titel
Skin Cancer and Hyperthermia and Radiotherapy (ICTRP)
Untersuchte Krankheit(en)
Basal Cell CarcinomaSquamous Cell Carcinoma SkinNon-melanoma Skin Cancer
(ICTRP)
Untersuchte Intervention
Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combinedRadiation: Radiotherapy (RT)
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Local control
(ICTRP)
Analysis;Late toxicities;Quality of life assessment
(ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Luzerner Kantonsspital;Lindenhofgruppe AG;Kantonsspital Aarau (ICTRP)
Weitere Kontakte
Maximilian Sturz, MD;Arnold Winfried, MD;Nidar Batifi, MSc;Winfried Arnold, MD, study-coordination-radiotherapy@ksw.ch, 0522665361;, Luzerner Kantonsspital,Luzerner Kantonsspital, (ICTRP)
Sekundäre IDs
SAHARA Trial (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06384053 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar