Clinical trial · Interventional
Skin Cancer and Hyperthermia and Radiotherapy
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
NCT06384053CI-TRIAL-00091028SAHARArecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Non-melanoma Skin Cancer | Skin Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma Skin | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy (RT) | Radiation | — | UNRESOLVED |
| Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hyperthermia -Experimental Group A
- description
- The 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.
- interventionNames
- Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined
- Radiation: Radiotherapy (RT)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy - Control Group
- description
- The 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.
- interventionNames
- Radiation: Radiotherapy (RT)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDArnold 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 41430304