Skin Cancer and Hyperthermia and Radiotherapy

Trial Title: Skin Cancer and Hyperthermia and Radiotherapy

NCT ID: NCT06384053

Condition: Basal Cell Carcinoma
Squamous Cell Carcinoma Skin
Non-melanoma Skin Cancer

Conditions: Official terms:
Carcinoma
Skin Neoplasms
Carcinoma, Basal Cell
Hyperthermia
Fever

Conditions: Keywords:
BCC
SCC skin
w-IRA hyperthermia
radiotherapy for non-melanoma skin cancer
non-melanoma Skin cancer
w-IRA combined with RT
hyperthermia

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Combination Product
Intervention name: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined
Description: 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.
Arm group label: Hyperthermia -Experimental Group A

Intervention type: Radiation
Intervention name: Radiotherapy (RT)
Description: Radiotherapy is applied.
Arm group label: Hyperthermia -Experimental Group A
Arm group label: Radiotherapy - Control Group

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.

Criteria for eligibility:
Criteria:
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)

Gender: All

Minimum age: 65 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Kantonsspital Winterthur

Address:
City: Winterthur
Zip: 8401
Country: Switzerland

Facility:
Name: Luzerner Kantonsspital

Address:
City: Luzern
Zip: 6000
Country: Switzerland

Contact:
Last name: Winfried Arnold, MD

Start date: July 1, 2024

Completion date: July 1, 2028

Lead sponsor:
Agency: Kantonsspital Winterthur KSW
Agency class: Other

Collaborator:
Agency: Luzerner Kantonsspital
Agency class: Other

Source: Kantonsspital Winterthur KSW

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06384053