Clinical trial NCT06384053: Skin Cancer and Hyperthermia and Radiotherapy
Official title: Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma Skin
Non-melanoma Skin Cancer
Keywords: BCC
SCC skin
w-IRA hyperthermia
radiotherapy for non-melanoma skin cancer
non-melanoma Skin cancer
w-IRA combined with RT
hyperthermia
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
Collaborators: name: Luzerner Kantonsspital
name: Lindenhofgruppe AG
name: Kantonsspital Aarau
First posted: 2024-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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)

Primary outcomes:
measure: Local control
timeFrame: Within two years post-treatment initiation.
Secondary outcomes:
measure: Analysis
timeFrame: Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment.
measure: Late toxicities
timeFrame: at 6months, one year and two years post-treatment
measure: Quality of life assessment
timeFrame: at three months, 6months, one year and two years post-treatment
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: AG
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Kanton Zuerich
city: Bern
country: Switzerland
facility: Lindenhofgruppe
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Luzerner Kantonsspital
name: Winfried Arnold, Dr.med.univ.(A)
role: PRINCIPAL_INVESTIGATOR
affiliation: Luzerner Kantonsspital
name: Maximilian Sturz, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: