Skin Cancer and Hyperthermia and Radiotherapy

Basal Cell Carcinoma Clinical Trial

— SAHARA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384053
• Other study ID #: SAHARA Trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: April 2024
• Source: Kantonsspital Winterthur KSW
• Contact: Nidar Batifi, MSc
• Phone: 0522665361
• Email: study-coordination-radiotherapy[@]ksw.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Several lesions exceeding the capacity of one treatment/radiation field (multiple lesions within one treatment field are acceptable)
• Previous (one month) or concurrent Chemo- or Immunotherapy
• Patients with connective tissue disorders (e.g. Sclerodermia, Lupus erythematodes)
• Lesions inside or in proximity (within 3cm) previously irradiated area
• Medical immunosuppression
• wIRA-specific exclusion criteria
• Tattoos in irradiated area
• Increased photosensitivity (either due to simultaneous treatment with photosensitivity-enhancing medications or conditions such as porphyria)

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Fever
• Hyperthermia
• Non-melanoma Skin Cancer
• Skin Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Kantonsspital Winterthur	Winterthur	Kanton Zuerich

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW	Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control	The primary outcome is local control, defined as the absence of of recurrence or need for subsequent intervention.	Within two years post-treatment initiation.
Secondary	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).	Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment.
Secondary	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).	at 6months, one year and two years post-treatment
Secondary	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.	at three months, 6months, one year and two years post-treatment