NCT06384053

Skin Cancer and Hyperthermia and Radiotherapy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kantonsspital Winterthur KSW · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Basal Cell Carcinoma
• Squamous Cell Carcinoma Skin
• Non-melanoma Skin Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2024-04-25
• Last updated: 2025-06-15

Locations

4 sites across 1 country: Switzerland