Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Local control
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Hyperthermia -Experimental Group A
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.
干预措施: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined (Combination Product)
Hyperthermia -Experimental Group A
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.
干预措施: Radiotherapy (RT) (Radiation)
Radiotherapy - Control Group
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.
干预措施: Radiotherapy (RT) (Radiation)
结局指标
主要结局
Local control
时间窗: Within two years post-treatment initiation.
The primary outcome is local control, defined as the absence of of recurrence or need for subsequent intervention.
次要结局
- Analysis(Immediately (within 24 hours post-treatment), at six weeks post-treatment and at three months post-treatment.)
- Late toxicities(at 6months, one year and two years post-treatment)
- Quality of life assessment(at three months, 6months, one year and two years post-treatment)