Skin Cancer and Hyperthermia and Radiotherapy

Last updated: June 11, 2025
Sponsor: Kantonsspital Winterthur KSW
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Cancer

Warts

Fever

Treatment

Radiotherapy (RT)

Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined

Clinical Study ID

NCT06384053
SAHARA Trial
  • Ages > 65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Personally signed and dated written informed consent

  • Histologically confirmed invasive non-melanoma skin cancer (NMSC), including basalcell 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, measuredon pathology report or imaging)

  • Local recurrence allowed, if primary treatment longer ago than 6 months (afterprimary treatment other than radiotherapy (RT))

  • Age ≥ 65 years

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2, with a lifeexpectancy of more than 6 months

  • Presentation at the Swiss Hyperthermia Network (SHN) tumor conference mandatory

Exclusion

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 (multiplelesions 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 withphotosensitivity-enhancing medications or conditions such as porphyria)

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Radiotherapy (RT)
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
July 01, 2028

Study 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.

Connect with a study center

  • Kantonsspital Aarau

    Aarau, AG 5001
    Switzerland

    Active - Recruiting

  • Kantonsspital Winterthur

    Winterthur, Kanton Zuerich 8401
    Switzerland

    Active - Recruiting

  • Lindenhofgruppe

    Bern, 3001
    Switzerland

    Active - Recruiting

  • Luzerner Kantonsspital

    Luzern, 6000
    Switzerland

    Active - Recruiting

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