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Recruiting NCT06384053

Skin Cancer and Hyperthermia and Radiotherapy

No phase Interventional Basal Cell Carcinoma Squamous Cell Carcinoma Skin Non-melanoma Skin Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined, Radiotherapy (RT).
Who it may be relevant to
Registry conditions: Basal Cell Carcinoma, Squamous Cell Carcinoma Skin, Non-melanoma Skin Cancer. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial

Overview

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 product Water-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.
  • Radiation Radiotherapy (RT)
    Radiotherapy is applied.

Primary outcome measures

  • Local control [Time frame: Within two years post-treatment initiation.]
Secondary outcome measures (3)
  • Analysis [Time frame: Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment.]
  • Late toxicities [Time frame: at 6months, one year and two years post-treatment]
  • Quality of life assessment [Time frame: at three months, 6months, one year and two years post-treatment]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 4 centers
  • Kantonsspital Aarau — Aarau
  • Kantonsspital Winterthur — Winterthur
  • Lindenhofgruppe — Bern
  • Luzerner Kantonsspital — Lucerne

Publications

  • 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. PMID 41430304

Identifiers

NCT: NCT06384053 · SAHARA Trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗