Skin Cancer and Hyperthermia and Radiotherapy
SAHARA
1 other identifier
interventional
100
1 country
4
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 25, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
June 15, 2025
January 1, 2025
1.5 years
April 15, 2024
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local control
The primary outcome is local control, defined as the absence of of recurrence or need for subsequent intervention.
Within two years post-treatment initiation.
Secondary Outcomes (3)
Analysis
Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment.
Late toxicities
at 6months, one year and two years post-treatment
Quality of life assessment
at three months, 6months, one year and two years post-treatment
Study Arms (2)
Hyperthermia -Experimental Group A
EXPERIMENTALThe study arm in which hyperthermia and radiotherapy are administered. The RT Dose: 6 fractions of 5 Gy each, delivered twice per week and with a minimum interval of 48 hours, preferably 72 hours, between each fraction over three weeks.
Radiotherapy - Control Group
ACTIVE COMPARATORThe study arm in which only radiotherapy is administered. RT Dose: 12 fractions of 4 Gy each, delivered 3 times per week, with sessions scheduled every other day (exceptions can be made in weeks with holidays) over four weeks.
Interventions
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.
Radiotherapy is applied.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Tattoos in irradiated area
- Increased photosensitivity (either due to simultaneous treatment with photosensitivity-enhancing medications or conditions such as porphyria)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kantonsspital Winterthur KSWlead
- Luzerner Kantonsspitalcollaborator
- Lindenhofgruppe AGcollaborator
- Kantonsspital Aaraucollaborator
Study Sites (4)
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001, Switzerland
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401, Switzerland
Lindenhofgruppe
Bern, 3001, Switzerland
Luzerner Kantonsspital
Lucerne, 6000, Switzerland
Related Publications (1)
Arnold W, Sturz M, Batifi N, Vaupel P, Notter M, Mueller-Hubenthal B, Puric E, Brodmann S, Zwahlen D. Skin cancer and hyperthermia and radiotherapy - SAHARA: study protocol for a multicenter, two-arm, open-label, randomized controlled phase II non-inferiority trial. Trials. 2025 Dec 22;26(1):574. doi: 10.1186/s13063-025-09274-y.
PMID: 41430304DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Winfried Arnold, Dr.med.univ.(A)
Luzerner Kantonsspital
- PRINCIPAL INVESTIGATOR
Maximilian Sturz, Dr.med.
Luzerner Kantonsspital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2024
First Posted
April 25, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2028
Last Updated
June 15, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share