Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Freedom from loco-regional progression
研究概览
简要总结
Adenoid cystic tumors are rare tumors of the head and neck region. Despite their slow growth, re-irradiation is often necessary due to the high metastatic risk. Patients are usually irradiated with photons or, as here at the Heidelberg University Hospital, with a combination of carbon ions and photons. So far, there is no data from Europe available for the sole irradiation with carbon ions. The present ACCO (Adenoid Cystic Carcinoma and Carbon ion Only irradiation) study, a prospective, open-label, phase II, single-arm, investigator-initiated study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity. Irradiation is applied - significantly shorter than the combination therapy - in about 4 weeks (22 fractions); patients are followed up for further 5 years after the start of therapy. Carbon ions alone are expected to increase local tumor control rates from 60% to 70% after 5 years (primary objective criterion of this study). In order to reject the null hypothesis with a power of 80% and a significance level of 5%, 175 patients are included (including a drop-out rate of 15%). Secondary objective criteria are progression-free survival, overall survival, acute and late toxicity, and quality of life.
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
- 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 adenoid cystic carcinoma in the head and neck area
- •Indication for irradiation:
- •non-operable or
- •R1/R2 resected or
- •perineural sheat invasion (Pn+) or
- •Informed consent
- •KI > 60% or ECOG 0/1 (minimum: self-sufficiency, normal activity or work not possible)
- •Age 18-80 years
排除标准
- •rejection of the study by the patient
- •Patient is not able to consent
- •Stage IV (distant metastases), except lung metastases < 1cm
- •lymph node involvement (clinical or pathological)
- •Previous radiotherapy in the head and neck area
- •Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)
- •Contraindication to MR imaging
- •Simultaneous participation in another clinical study that could influence the outcome of this study or the other study
- •Pregnancy
结局指标
主要结局
Freedom from loco-regional progression
时间窗: at 5 years
Freedom from loco-regional tumor progression according to MR imaging
次要结局
- Acute toxicities(during and up to 6 weeks after radiotherapy)
- Progression-free survival(at 3 and 5 years)
- Late toxicities(up to 5 years)
- Overall survival(at 3 and 5 years)
研究者
Klaus Herfarth, MD
Prof. Dr. Klaus Herfarth, Vice chair Dept. of Radiation Oncology
Heidelberg University