RecruitingNot ApplicableNCT06384053

Skin Cancer and Hyperthermia and Radiotherapy

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


Sponsor

Kantonsspital Winterthur KSW

Enrollment

100 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding heat therapy (hyperthermia) to radiation therapy improves outcomes for older patients with non-melanoma skin cancers (basal cell carcinoma or squamous cell carcinoma) that are too large or complex for surgery alone. **You may be eligible if...** - You are 65 or older - You have a histologically confirmed basal cell or squamous cell skin cancer - Your tumor is at least stage T2 and up to 2 cm thick - You are in reasonably good health and your expected survival is more than 6 months **You may NOT be eligible if...** - Your cancer is a different type (not BCC or SCC) - Your tumor is early stage (T1) or has spread to lymph nodes - You are currently receiving chemotherapy or immunotherapy - You have a connective tissue disorder like lupus or scleroderma - You are on immune-suppressing medications - You have tattoos in the treatment area or increased sensitivity to light Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTWater-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.

RADIATIONRadiotherapy (RT)

Radiotherapy is applied.


Locations(4)

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Lindenhofgruppe

Bern, Switzerland

Luzerner Kantonsspital

Lucerne, Switzerland

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NCT06384053


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