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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Combination product, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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)

• Local recurrence allowed, if primary treatment longer ago than 6 months (after primary treatment other than radiotherapy (RT))

• Age ≥ 65 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2, with a life expectancy of more than 6 months

• Presentation at the Swiss Hyperthermia Network (SHN) tumor conference mandatory

Locations
Other Locations
Switzerland
Kantonsspital Aarau
RECRUITING
Aarau
Lindenhofgruppe
RECRUITING
Bern
Luzerner Kantonsspital
RECRUITING
Lucerne
Kantonsspital Winterthur
RECRUITING
Winterthur
Contact Information
Primary
Nidar Batifi, MSc
sahara-team@ksw.ch
+41522665361
Backup
Daniel Zwahlen, Prof. Dr. med.
radioonkologie@ksw.ch
+4152 266 26 53
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 100
Treatments
Experimental: Hyperthermia -Experimental Group A
The study arm in which hyperthermia and radiotherapy are administered. The RT Dose: 6 fractions of 5 Gy each, delivered twice per week and with a minimum interval of 48 hours, preferably 72 hours, between each fraction over three weeks.
Active_comparator: Radiotherapy - Control Group
The study arm in which only radiotherapy is administered. RT Dose: 12 fractions of 4 Gy each, delivered 3 times per week, with sessions scheduled every other day (exceptions can be made in weeks with holidays) over four weeks.
Sponsors
Leads: Kantonsspital Winterthur KSW
Collaborators: Luzerner Kantonsspital, Kantonsspital Aarau, Lindenhofgruppe AG

This content was sourced from clinicaltrials.gov