Basal Cell CarcinomaSAHARANCT06384053
Skin Cancer and Hyperthermia and Radiotherapy
A study testing Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined and Radiotherapy (RT) in people with Basal Cell Carcinoma and Squamous Cell Carcinoma Skin, run by Kantonsspital Winterthur KSW at 4 sites in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma Skin, Non-melanoma Skin Cancer
- What is being tested?
- Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined and Radiotherapy (RT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 1 Jan 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001
Emsad Puric, Dr. med.
- Recruiting
Lindenhofgruppe
Bern, 3001
Markus Notter, Dr. med., +41 31 300 95 11
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Winfried Arnold, Dr.med.univ.(A)
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Nidar Batifi, MSc, study-coordination-radiotherapy@ksw.ch
Stefan Brodmann, Dr.med.
About this study
Official title: Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
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).
Read the detailed description
The SAHARA Trial is investigating if adding hyperthermia to radiotherapy (RT) can enhance treatment outcomes by making cancer cells more sensitive to radiation, thus requiring lower doses and potentially reducing side effects. The trial compares high-dose RT alone with de-escalated RT plus hyperthermia. The aim is to demonstrate that the combination is non-inferior to standard RT in treating non-melanoma skin cancer (NMSC). The trial is designed for elderly people of 65 years or older.
- Being tested
- Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined, Radiotherapy (RT)
- Keywords
- BCC, SCC skin, w-IRA hyperthermia, radiotherapy for non-melanoma skin cancer, non-melanoma Skin cancer, w-IRA combined with RT, hyperthermia
- Medical subject headings
- Carcinoma, Basal Cell, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combinedCombination product
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 (RT)Radiation
Radiotherapy is applied.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia -Experimental Group A | Experimental | 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. Receives: Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined; Radiation: Radiotherapy (RT) |
| Radiotherapy - Control Group | Active comparator | 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. Receives: Radiation: Radiotherapy (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
The primary outcome is local control, defined as the absence of of recurrence or need for subsequent intervention.
Measured: Within two years post-treatment initiation.
Secondary outcomes (3)
Analysis
Radiation is applied assessed immediately post-treatment, at six weeks, and three months post-treatment using Common Terminology Criteria for Adverse events (CTCAE 5.0).
Measured: Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment.
Late toxicities
Monitoring late toxicities, specifically noted at six months, one year, and two years after completion of treatment using Common Terminology Criteria for Adverse events (CTCAE 5.0).
Measured: at 6months, one year and two years post-treatment
Quality of life assessment
Evaluations are carried out at time of inclusion, immediately post-treatment, at three months, 6months, one year and two years post-treatment utilizing the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Elderly (QLQ-ELD14) questionnaire.
Measured: at three months, 6months, one year and two years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Jan 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Collaborators
- Luzerner Kantonsspital, Lindenhofgruppe AG, Kantonsspital Aarau
- Responsible party
- Sponsor
- Investigators
- Winfried Arnold, Dr.med.univ.(A), Principal investigator, Luzerner KantonsspitalMaximilian Sturz, Dr.med., Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384053
- Sponsor's protocol ID
- SAHARA Trial
- Acronym
- SAHARA
- Status last verified
- Jan 2025
- First submitted
- 15 Apr 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41430304
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT06384053
- Acronym / sponsor ID
- SAHARA / SAHARA Trial
- Keywords
- BCC, SCC skin, w-IRA hyperthermia, radiotherapy for non-melanoma skin cancer, non-melanoma Skin cancer, w-IRA combined with RT, hyperthermia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Collaborators
- Luzerner Kantonsspital, Lindenhofgruppe AG, Kantonsspital Aarau
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The SAHARA Trial is investigating if adding hyperthermia to radiotherapy (RT) can enhance treatment outcomes by making cancer cells more sensitive to radiation, thus requiring lower doses and potentially reducing side effects. The trial compares high-dose RT alone with de-escalated RT plus hyperthermia. The aim is to demonstrate that the combination is non-inferior to standard RT in treating non-melanoma skin cancer (NMSC). The trial is designed for elderly people of 65 years or older.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia -Experimental Group A | Experimental | Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined, Radiation: Radiotherapy (RT)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. |
| Radiotherapy - Control Group | Active comparator | Radiation: Radiotherapy (RT)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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))
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combinedThe 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. | Combination product | Hyperthermia -Experimental Group A |
| Radiotherapy (RT)Radiotherapy is applied. | Radiation | Hyperthermia -Experimental Group A, Radiotherapy - Control Group |
Primary outcome
Local control
Time frame: Within two years post-treatment initiation.
The primary outcome is local control, defined as the absence of of recurrence or need for subsequent intervention.
3 secondary outcomes
Analysis
Time frame: Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment.
Late toxicities
Time frame: at 6months, one year and two years post-treatment
Quality of life assessment
Time frame: at three months, 6months, one year and two years post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Derived from this study: PubMed 41430304Arnold 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Winfried Arnold, Dr.med.univ.(A) principal investigator
Luzerner Kantonsspital
Maximilian Sturz, Dr.med. principal investigator
Luzerner Kantonsspital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined and Radiotherapy (RT) in people with Basal Cell Carcinoma and Squamous Cell Carcinoma Skin, run by Kantonsspital Winterthur KSW at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nidar Batifi, MSc (+41522665361, sahara-team@ksw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: Within two years post-treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06384053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.