Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06384053

Skin Cancer and Hyperthermia and Radiotherapy

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Basal Cell Carcinoma Body Temperature Changes Carcinoma Carcinoma, Basal Cell Heat Stress Disorders Hyperthermia Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Non-Melanoma Skin Cancer Pathological Conditions, Signs and Symptoms Signs and Symptoms Squamous Cell Carcinoma Skin Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Aarau, Aarau, Canton of Aargau, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Combination Product

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.

Radiotherapy (RT)

Radiation

Radiotherapy is applied.

Primary outcomes

  1. Local control

    Time frame: 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 outcomes

  1. Analysis

    Time frame: 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).

  2. Late toxicities

    Time frame: 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).

  3. Quality of life assessment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Zwahlen, Prof. Dr. med.

CONTACT

[email protected]

+4152 266 26 53

Nidar Batifi, MSc

CONTACT

[email protected]

+41522665361

Sponsors and collaborators

Lead sponsor

Kantonsspital Winterthur KSW

Other

Collaborators

  • Kantonsspital Aarau
  • Lindenhofgruppe AG
  • Luzerner Kantonsspital

Registry information

Official study title

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

Acronym: SAHARA

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 25, 2024
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.