Skin Cancer and Hyperthermia and Radiotherapy (SAHARA)

Kantonsspital Winterthur KSW

Status: Enrolling

Conditions: Non-melanoma Skin Cancer; Squamous Cell Carcinoma Skin; Basal Cell Carcinoma

Treatments: Radiation: Radiotherapy (RT); Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06384053

SAHARA Trial

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Hyperthermia -Experimental Group A

Experimental group

Description:

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.

Treatment:

Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined

Radiation: Radiotherapy (RT)

Radiotherapy - Control Group

Active Comparator group

Description:

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.

Treatment:

Radiation: Radiotherapy (RT)