Skin Cancer and Hyperthermia and Radiotherapy

Not Applicable

Not yet recruiting

• Conditions: Squamous Cell Carcinoma Skin; Basal Cell Carcinoma; Non-melanoma Skin Cancer
• Interventions: Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined; Radiation: Radiotherapy (RT)

• Registration Number: NCT06384053
• Lead Sponsor: Kantonsspital Winterthur KSW

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-22
• Last Update Submitted: 2024-04-22
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Study Start: 2024-07-01
• Primary Completion: 2026-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperthermia -Experimental Group A	Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined	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.
Hyperthermia -Experimental Group A	Radiotherapy (RT)	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.
Radiotherapy - Control Group	Radiotherapy (RT)	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.

Primary Outcome Measures

Name	Time	Method
Local control	Within two years post-treatment initiation.	The primary outcome is local control, defined as the absence of of recurrence or need for subsequent intervention.

Secondary Outcome Measures

Name	Time	Method
Analysis	Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment.	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).
Quality of life assessment	at three months, 6months, one year and two years post-treatment	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.
Late toxicities	at 6months, one year and two years post-treatment	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).

Trial Locations

Locations (2)

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Kanton Zuerich, Switzerland