Combined Therapy of Malignant Salivary Gland Tumours With IMRT and Carbon Ions: COSMIC
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- mucositis ≥ CTC°3
研究概览
简要总结
The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, and toxicity. Planned accrual of the trial includes 54 patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland malignancies. Treatment consists of 24 GyE carbon ions (8 fractions) and 50 Gy IMRT (2.0 Gy/ fraction).
详细描述
Local control in malignant salivary gland tumours is dose dependent. High local control rates in adenoid cystic carcinomas could be achieved by highly conformal radiotherapy techniques and particle (neutron/ carbon ion) therapy. Considering high doses are needed to achieve local control, all malignant salivary gland tumours probably profit from the use of particle therapy, which in case of carbon ion treatment, has been shown to be accompanied by only mild side-effects.
Methods/ design:
The COSMIC trial is a prospective, mono-centric, phase II trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost in 54 patients with histologically proved (≥R1-resected, inoperable or Pn+) salivary gland malignancies. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).
Study objectives:
Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, toxicity (incl. mucositis CTC °I-II and late toxicity at 3 years post RT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 confirmed or surgically removed malignant tumour of the salivary glands (head and neck)
- •Inoperable tumour
- •Macroscopic or microscopic residual tumour (R2/ R1) or
- •≥T3/T4 or
- •perineural invasion (Pn+)
- •written informed consent
- •pts aged 18 - 80 years
- •effective contraception for pts in childbearing age (<12 months post beginning of menopause)
排除标准
- •Prior radio- or chemotherapy for tumours of the head and neck
- •Other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
- •Legal incapacity or limited legal capacity
- •Positive serum/ urine beta-HCG/ pregnancy
- •Drug abuse
结局指标
主要结局
mucositis ≥ CTC°3
时间窗: 6-8 weeks post completion of treatment
次要结局
- local control(3 years post RT)
- acute toxicity(6-8 weeks post completion of treatment)
- late toxicity(3 years post radiotherapy)
- disease-free survival(3 years post treatment)