Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Luzerner Kantonsspital | OTHER |
| Lindenhofgruppe AG | INDUSTRY |
| Kantonsspital Aarau | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined | Combination 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment. |
| Late toxicities |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nidar Batifi, MSc | Contact | +41522665361 | sahara-team@ksw.ch | |
| Daniel Zwahlen, Prof. Dr. med. | Contact | +4152 266 26 53 | radioonkologie@ksw.ch |
| Name | Affiliation | Role |
|---|---|---|
| Winfried Arnold, Dr.med.univ.(A) | Luzerner Kantonsspital | Principal Investigator |
| Maximilian Sturz, Dr.med. | Luzerner Kantonsspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Recruiting | Aarau | Canton of Aargau | 5001 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41430304 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Radiotherapy (RT) | Radiation | Radiotherapy is applied. |
|
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). |
| 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. | at three months, 6months, one year and two years post-treatment |
| Kantonsspital Winterthur | Recruiting | Winterthur | Canton of Zurich | 8401 | Switzerland |
|
| Lindenhofgruppe | Recruiting | Bern | 3001 | Switzerland |
|
| Luzerner Kantonsspital | Recruiting | Lucerne | 6000 | Switzerland |
|
| D018295 |
| Neoplasms, Basal Cell |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |