Basal Cell Carcinoma Clinical Trial
— SAHARAOfficial 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).
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | July 1, 2028 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Luzerner Kantonsspital | Luzern | |
Switzerland | Kantonsspital Winterthur | Winterthur | Kanton Zuerich |
Lead Sponsor | Collaborator |
---|---|
Kantonsspital Winterthur KSW | Luzerner Kantonsspital |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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). | at 6months, one year and two years post-treatment | |
Secondary | 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 |
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