Skin Cancer and Hyperthermia and Radiotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorKantonsspital Winterthur KSW
About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined
Combination productThe 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)
RadiationRadiotherapy is applied.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Hyperthermia -Experimental Group AExperimental treatment 2 interventions
Group B: Radiotherapy - Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Local control
The primary outcome is local control, defined as the absence of of recurrence or need for subsequent intervention.
Time frame
Within two years post-treatment initiation.Secondary outcomes
1
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).
Time frame
Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment.2
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).
Time frame
at 6months, one year and two years post-treatment3
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.
Time frame
at three months, 6months, one year and two years post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kantonsspital Winterthur KSW
Lead sponsor
Luzerner Kantonsspital
Collaborator
Lindenhofgruppe AG
Collaborator
Kantonsspital Aarau
Collaborator
Source ClinicalTrials.gov