Radiotherapy Related Skin Toxicity: Mepitel® Film vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set)
研究概览
简要总结
The aim for the present study named RAREST (RAdiotherapy RElated Skin Toxicity) is to compare the new dressing with the standard skin care. 168 patients receiving radiotherapy alone or radiochemotherapy for locally advanced head-and-neck cancer will be included. The primary aim is to investigate the rate of patients experiencing severe, stressful radiation dermatitis. The skin status will daily be inspected and assessed by specially trained doctors and nursing staff.
It is expected that the new self-adhesive dressing is superior to standard care with respect to prevention of grade ≥2 radiation dermatitis in patients receiving radiotherapy or radio(chemo)therapy for a head-and-neck tumor. Thus, the dressing would be well qualified to become a new standard procedure at the skin care of patients with a head-neck tumor.
详细描述
The primary goal of this randomized trial is to demonstrate that Mepitel® Film is superior to Standard Care with respect to prevent grade ≥2 radiation dermatitis (RD) in patients receiving radio(chemo)therapy up to 50 Gy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).
The primary aim of this randomized multinational multicenter trial is to investigate the rate of patients experiencing grade ≥2 RD (CTCAE v4.03) until 50 Gy of radiotherapy (RT).
Evaluation until 50 Gy of RT is the primary endpoint, since up to 50 Gy, the irradiated volume includes the primary tumor and the bilateral cervical and supraclavicular lymph nodes, and, therefore, is almost identical in all patients. After 50 Gy, the irradiated volume is much more individual, depending on location and size of the primary tumor, involvement of lymph nodes, and the treatment approach (definitive vs. adjuvant).
This is a randomized, active-controlled, parallel-group trial, comparing the following treatments of radiation related skin toxicity in patients with head-and-neck cancer:
Mepitel® Film (Arm A) vs. Standard Care (Arm B). About 4 contributing centers are planned to include an average of 21 patients/year. The recruitment duration of 168 patients = 24 months. The follow-up period will be 3 weeks. The total running time = 25 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven locally advanced squamous cell carcinoma of the head-and-neck (SCCHN)
- •Conventionally fractionated (5x2 Gy per week) definitive or adjuvant radio(chemo)therapy
- •Age ≥18 years
- •Written informed consent
- •Capacity of the patient to contract
排除标准
- •N3 stage (lymph nodes >6 cm)
- •Distant metastases (M1)
- •Pregnancy, Lactation
- •Treatment with epidermal growth factor receptor (EGFR)-antibodies (either given or planned)
- •Expected non-compliance
结局指标
主要结局
Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set)
时间窗: at 50 Gy (about 5 weeks)
Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
次要结局
- Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Per Protocol Set)(at 60 Gy (about 6 weeks))
- Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Per Protocol Set)(at 50 Gy (about 5 weeks))
- Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Per Protocol Set)(at 60 Gy (about 6 weeks))
- Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)(at 50 Gy (about 5 weeks))
- Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)(at 60 Gy (about 6 weeks))
- Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)(at 50 Gy (about 5 weeks))
- Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)(at 60 Gy (about 6 weeks))
- Median Number of Radiation Fractions Until Occurence of Grade 2 Dermatitis(up to 50 Gy (about 5 weeks))
- Median Pain Score at the Irradiated Skin at 50 Gy(at 50 Gy (about 5 weeks))
- Median Pain Score at the Irradiated Skin at 60 Gy(at 60 Gy (about 6 weeks))
- Change in Quality of Life Between Screening and 50 Gy of Radiotherapy(at 50 Gy (about 5 weeks))
研究者
Prof. Dirk Rades, MD
Professor Dr. med.
University Hospital Schleswig-Holstein