Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT06384053

Skin Cancer and Hyperthermia and Radiotherapy

Led by Kantonsspital Winterthur KSW · Updated on 2025-06-15

100

Participants Needed

4

Research Sites

182 weeks

Total Duration

On this page

Sponsors

K

Kantonsspital Winterthur KSW

Lead Sponsor

L

Luzerner Kantonsspital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Skin Cancer and Hyperthermia and Radiotherapy

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent
  • Histologically confirmed invasive non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma)
  • Tumor stage T2 or higher (TNM Classification 8th Edition)
  • Tumor thickness up to 2 cm (based on pathology or imaging)
  • Local recurrence allowed if primary treatment was more than 6 months ago (excluding prior radiotherapy)
  • Age 65 years or older
  • ECOG performance status 0 to 2 with life expectancy over 6 months
  • Presentation at Swiss Hyperthermia Network tumor conference required
Not Eligible

You will not qualify if you...

  • Any cancer histology other than basal cell carcinoma or squamous cell carcinoma
  • Tumor stage T1 or presence of lymph node involvement (N+)
  • Tumors after incomplete resection (R1 or R2) or requiring adjuvant treatment
  • Tumor invading critical areas
  • Multiple lesions exceeding one treatment/radiation field capacity
  • Chemotherapy or immunotherapy within one month prior or ongoing
  • Connective tissue disorders such as scleroderma or lupus erythematosus
  • Lesions inside or within 3 cm of previously irradiated areas
  • Medical immunosuppression
  • Tattoos in irradiated area
  • Increased photosensitivity due to medications or conditions like porphyria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland, 5001

Actively Recruiting

2

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland, 8401

Actively Recruiting

3

Lindenhofgruppe

Bern, Switzerland, 3001

Actively Recruiting

4

Luzerner Kantonsspital

Lucerne, Switzerland, 6000

Actively Recruiting

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Research Team

N

Nidar Batifi, MSc

CONTACT

D

Daniel Zwahlen, Prof. Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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