RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Local progression-free survival at 12 months following RT.
研究概览
简要总结
This clinical study aims to investigate whether high-precision radiotherapy, as supposed, leads to a better control of the irradiated spinal cord metastases when compared to conventional radiotherapy. This means that a progression or recurrence of motor deficits (weakness) of the legs following radiotherapy can be avoided more effectively. Furthermore, the high-precision radiotherapy will be compared to the conventional radiotherapy with respect to pain relief, motor function/ability to walk, quality of life, side effects and survival.
详细描述
The aim of this single-arm study is to show that high-precision radiotherapy (RT) with 18x2.33 Gy in 3.5 weeks results in significantly better local progression free survival (LPFS) of metastatic spinal cord compression (MSCC) when compared to conventional RT with 10x3 Gy in 2 weeks. If such superiority could be shown, 18x2.33 Gy could be recommended, at least for those patients with favourable survival prognoses, since an in-field recurrence of MSCC in the irradiated part of the spine is generally very difficult to treat.
For this investigation the newly prospectively collected data will be compared with a historical cohort collected up to the time of data analysis.
The recruitment of all 65 patients (62 patients + 5% for potential drop-outs) is planned to be completed within 21 months. The follow-up period will be 12 months. This equals a total running time for the study of 33 months.
In accordance with a previous study assessing local control of MSCC, the following patient characteristics will be recorded to allow adequate comparison with the historical control group:
- Age
- Gender
- Type of primary tumor (breast cancer vs. prostate cancer vs. myeloma/ lymphoma vs. lung cancer vs. other tumors)
- Interval from tumor diagnosis to MSCC (≤15 months vs. >15 months)
- Number of involved vertebrae (1-2 vs. ≥3)
- Other bone metastases at the time of RT (no vs. yes)
- Visceral metastases at the time of RT (no vs. yes)
- Time developing motor deficits prior to RT (1-7 days vs. 8-14 days vs. >14 days)
- Ambulatory status prior to RT (no vs. yes)
- Eastern Cooperative Oncology Group (ECOG) performance score (0-2 vs- 3-4)
- Indication for decompressive surgery of affected spinal areas
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Motor deficits of the lower extremities resulting from MSCC, which have persisted for no longer than 30 days
- •Confirmation of diagnosis by MR-imaging (computed tomography [CT] allowed)
- •Age 18 years or older
- •Written informed consent
- •Favorable survival prognosis (defined as 36-45 points on the survival score)
- •Capacity of the patient to contract
排除标准
- •Previous RT or surgery of the spinal areas affected by MSCC
- •Symptomatic brain tumor or symptomatic brain metastases
- •Metastases of the cervical spine only
- •Other severe neurological disorders
- •Pregnancy, Lactation
- •Clear indication for spinal surgery
结局指标
主要结局
Local progression-free survival at 12 months following RT.
时间窗: For each patient 12 months after the end of RT.
LPFS time will be calculated from the last day of the RT. The evaluation will be performed in those patients, who are available for assessement of the Primary endpoint and have received at least 80% of the planned RT dose.
次要结局
- Change in motor function/ability to walk(Assessment directly and at 1, 3, 6, 9 and 12 months after RT.)
- Overall survival(Evaluation directly and at 1, 3, 6, 9 and 12 months after RT)
- Change in quality of life(Evaluation directly and at 1, 3, 6, 9 and 12 months after RT)
- Change in sensory function(Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT)
- Chance in sphincter dysfunction(Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT)
- Occurence of toxicity(Evaluation during RT and directly, 1, 3, 6, 9 and 12 months after RT)
- Local progression-free survival(Additional evaluation directly and 1, 3, 6 and 9 months after RT)
- Change in vertebral pain(Evaluation directly and at 1, 3, 6, 9 and 12 months after RT)
研究者
Prof Dirk Rades
Chair of the Department of Radiation Oncology, University of Luebeck
University Hopsital Schleswig Holstein Campus Lübeck