Basal Cell Carcinoma, Squamous Cell Carcinoma Skin, Non-melanoma Skin Cancer
Conditions
Keywords
BCC, SCC skin, w-IRA hyperthermia, radiotherapy for non-melanoma skin cancer, non-melanoma Skin cancer, w-IRA combined with RT, hyperthermia
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).
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.
Interventions
COMBINATION_PRODUCTWater-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined
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.
RADIATIONRadiotherapy (RT)
Radiotherapy is applied.
Sponsors
Luzerner Kantonsspital
Lindenhofgruppe AG
Kantonsspital Aarau
Kantonsspital Winterthur KSW
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control | Within two years post-treatment initiation. | The primary outcome is local control, defined as the absence of of recurrence or need for subsequent intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis | Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment. | 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). |
| Late toxicities | at 6months, one year and two years post-treatment | 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). |
| Quality of life assessment | at three months, 6months, one year and two years post-treatment | 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. |
Countries
Switzerland
Contacts
Primary ContactNidar Batifi, MSc
Backup ContactDaniel Zwahlen, Prof. Dr. med.
Outcome results
None listed