Skin cancer treatment with heat treatment (hyperthermia) and radiation therapy – SAHARA, an open-label, two-arm, randomized, controlled Phase II study.
Résumé de l'étude
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 étudiée
non-melanoma skin cancer (NMSC), white skin cancer.
(BASEC)
Maladie en cours d'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)
Critères d'exclusion
(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)
Lieu de l’étude
Aarau, Berne, Luzern, Winterthur
(BASEC)
Sponsor
Prof. Dr. med. Daniel R. Zwahlen
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Nidar Batifi
0522665361
nidar.batifi@clutterksw.chKantonsspital Winterthur
(BASEC)
Informations générales
Luzerner Kantonsspital,Luzerner Kantonsspital,
0522665361;
study-coordination-radiotherapy@ksw.ch(ICTRP)
Informations générales
Luzerner KantonsspitalLuzerner Kantonsspital
+41522665361
sahara-team@ksw.ch(ICTRP)
Informations scientifiques
Luzerner Kantonsspital,Luzerner Kantonsspital,
0522665361;
study-coordination-radiotherapy@ksw.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
28.06.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06384053 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Hautkrebsbehandlung mit Wärmebehandlung (Hyperthermie) und Strahlentherapie – SAHARA, eine offene, zwei-armige, zufällig zugewiesene, kontrollierte Phase II Studie. (BASEC)
Titre académique
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial (ICTRP)
Titre public
Skin Cancer and Hyperthermia and Radiotherapy (ICTRP)
Maladie en cours d'investigation
Basal Cell CarcinomaSquamous Cell Carcinoma SkinNon-melanoma Skin Cancer
(ICTRP)
Intervention étudiée
Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combinedRadiation: Radiotherapy (RT)
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
(ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Local control
(ICTRP)
Analysis;Late toxicities;Quality of life assessment
(ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Luzerner Kantonsspital;Lindenhofgruppe AG;Kantonsspital Aarau (ICTRP)
Contacts supplémentaires
Maximilian Sturz, MD;Arnold Winfried, MD;Nidar Batifi, MSc;Winfried Arnold, MD, study-coordination-radiotherapy@ksw.ch, 0522665361;, Luzerner Kantonsspital,Luzerner Kantonsspital, (ICTRP)
ID secondaires
SAHARA Trial (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT06384053 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible