Skin Cancer and Hyperthermia and Radiotherapy

Launched by KANTONSSPITAL WINTERTHUR KSW · Apr 22, 2024

Keywords

ClinConnect Summary

The SAHARA trial is a clinical study designed to test a new way of treating non-melanoma skin cancers, specifically basal cell carcinoma and squamous cell carcinoma. Researchers want to see if combining a special type of radiation therapy, called ultrahypofractionated accelerated radiotherapy, with a treatment called hyperthermia (which involves heating the skin) is just as effective as the standard high-dose radiation therapy currently used. This trial is not yet recruiting participants, but it aims to include adults aged 65 and older who have been diagnosed with more advanced skin cancer that has a certain thickness.

To be eligible for the trial, participants must provide written consent and have a confirmed diagnosis of invasive non-melanoma skin cancer. They should also be in relatively good health, with a life expectancy of more than six months. However, individuals with certain conditions, like other types of skin cancer or previous treatments that could interfere with the study, may not qualify. Those who participate can expect to receive the new treatment approach and be monitored closely for its effectiveness. It's important for potential participants to understand these details before considering joining the trial.

Gender

ALL

Eligibility criteria

• 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)