ESO-SPARE: Esophagus Sparring Radiotherapy for Thoracic and Cervical Metastatic Spinal Cord Compression. A Randomized Phase III Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Ambulatory function
研究概览
简要总结
Metastatic spinal cord compression (MSCC) is a serious complication to metastatic cancer and when diagnosed life expectancy is short. Treatment is palliative radiotherapy (RT). Early esophageal toxicity is underreported but can seriously impact quality of life (QoL).
The aim of the ESO-SPARE trial is to investigate if esophagus sparing RT can decrease patient reported esophageal toxicity without compromising ambulatory function or increase other toxicities.
200 patients with MSCC in the thoracic or cervical spine referred for RT will be randomized to either standard or esophagus/pharynx sparing RT. Subsequently participants will be followed with PROM (Patient Reported Outcome Measures) for 9 weeks. PROM-CTCAE questionnaires on upper GI toxicity and pain will be collected daily for 5 weeks and weekly for 4 weeks. Questionnaires evaluating QoL and physical function will be collected weekly for 9 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The outcome of randomization is not reviled to the patient.
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
- •Histology or cytology proven cancer
- •Referred for palliative radiotherapy of the cervical or thoracic vertebra for
- •epidural ingrowth
- •metastatic spinal cord compression
- •metastatic spinal nerve root compression
- •post-operative radiotherapy after decompressive surgery for spinal cord or nerve root compression
- •Ability to understand and the willingness to sign a written informed consent document
- •Referred for the following dose prescriptions 5 Gy x 5, 5 Gy x 4, 3 Gy x 10, 10 Gy x 1, 8 Gy x
- •≥ 18 years old.
排除标准
- •Referred for > 10 fractions
结局指标
主要结局
Ambulatory function
时间窗: Measured 9 weeks after treatment start
Preserved ability to walk will be evaluated using the European Quality of Life - 5 Dimensions questionnaire (EQ-5D-5L) mobility dimension. The EQ-5D includes one question for each of the five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5).
Early patient reported gastro-oesophageal toxicity
时间窗: Measured within the first 5 weeks after treatment start
Measured as a peak score using CTCAE Patient Reported Outcome Measures
次要结局
- Analgesic consumption(Assessed Weekly over a period of 9 weeks)
- Pain assessment (MTS site)(Best response during 9 weeks of follow-up)
- Duration of gastro-oesophageal toxicity(Assessed 9 weeks after treatment start)
- Reirradiation rate - Overall survival (OS)(Assessed 6 months after inclusion of the last patient.)
- Patient reported physical function(Assessed Weekly over a period of 9 weeks)
- Weight(Assessed Weekly over a period of 9 weeks)
- Pain (MSCC site)(Assessed daily for 5 weeks and subsequently weekly for 4 weeks.)
- Health related Quality of life (QoL)(Assessed Weekly over a period of 9 weeks)
研究者
Anna Mann Nielsen
Principal Investigator, MD
Herlev Hospital