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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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 is applied.
Kantonsspital Aarau
Aarau, Canton of Aargau, Switzerland
RECRUITINGKantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland
RECRUITINGLindenhofgruppe
Bern, Switzerland
RECRUITINGLocal 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.
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.
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-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.
Time frame: at three months, 6months, one year and two years post-treatment
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Luzerner Kantonsspital
Lucerne, Switzerland
RECRUITING