Skin Cancer and Hyperthermia and Radiotherapy (SAHARA)

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).

Study Overview

• Status: Recruiting
• Conditions: Basal Cell Carcinoma; Non-melanoma Skin Cancer; Squamous Cell Carcinoma Skin
• Intervention / Treatment: Combination product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined; Radiation: Radiotherapy (RT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nidar Batifi, MSc; Phone Number: +41522665361; Email: sahara-team@ksw.ch
• Study Contact Backup: Name: Daniel Zwahlen, Prof. Dr. med.; Phone Number: +4152 266 26 53; Email: radioonkologie@ksw.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3001
    • Recruiting
    • Lindenhofgruppe
    • Contact: Markus Notter, Dr. med.; Phone Number: +41 31 300 95 11
  • Luzern, Switzerland, 6000
    • Recruiting
    • Luzerner Kantonsspital
    • Contact: Winfried Arnold, Dr.med.univ.(A)
  • AG
    • Aarau, AG, Switzerland, 5001
      • Recruiting
      • Kantonsspital Aarau
      • Contact: Emsad Puric, Dr. med.
  • Kanton Zuerich
    • Winterthur, Kanton Zuerich, Switzerland, 8401
      • Recruiting
      • Kantonsspital Winterthur
      • Contact: Nidar Batifi, MSc; Email: study-coordination-radiotherapy@ksw.ch
      • Principal Investigator: Stefan Brodmann, Dr.med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperthermia -Experimental Group A; The study arm in which hyperthermia and radiotherapy are administered. The RT Dose: 6 fractions of 5 Gy each, delivered twice per week and with a minimum interval of 48 hours, preferably 72 hours, between each fraction over three weeks.	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.
Active Comparator: Radiotherapy - Control Group; The study arm in which only radiotherapy is administered. RT Dose: 12 fractions of 4 Gy each, delivered 3 times per week, with sessions scheduled every other day (exceptions can be made in weeks with holidays) over four weeks.	Radiation: Radiotherapy (RT); Radiotherapy is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW
• Collaborators: Kantonsspital Aarau; Luzerner Kantonsspital; Lindenhofgruppe AG
• Investigators: Principal Investigator: Winfried Arnold, Dr.med.univ.(A), Luzerner Kantonsspital; Principal Investigator: Maximilian Sturz, Dr.med., Luzerner Kantonsspital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: hyperthermia; BCC; SCC skin; w-IRA hyperthermia; radiotherapy for non-melanoma skin cancer; non-melanoma Skin cancer; w-IRA combined with RT
• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Body Temperature Changes; Neoplasms, Basal Cell; Heat Stress Disorders; Hyperthermia; Carcinoma; Skin Neoplasms; Carcinoma, Basal Cell; Fever
• Other Study ID Numbers: SAHARA Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No