Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease (SPEED-RT)
This study evaluates a new radiation treatment approach for patients with cancer that has spread to the spine (vertebral metastases) and involves limited extension around the spinal cord without causing compression (non-compressive epiduritis). This condition is common and can lead to serious complications, including pain and spinal cord compression, potentially affecting mobility and quality of life.
The current standard of care is conventional radiotherapy, which is effective for symptom relief but may provide limited long-term tumor control. As advances in cancer treatments have improved survival, there is an increasing need for treatment approaches that better prevent local tumor progression in the spine.
This randomized clinical trial compares standard radiotherapy with stereotactic radiotherapy (SRT), an advanced and highly precise radiation technique that delivers higher doses directly to the tumor while minimizing exposure to surrounding healthy tissues, including the spinal cord.
The primary objective is to determine whether SRT can improve local disease control while maintaining an acceptable safety profile. The study will evaluate the proportion of patients who are alive without spinal disease progression (including spinal cord compression or local tumor recurrence) at one year after treatment. Secondary outcomes include treatment-related side effects, time to disease progression, overall survival, quality of life, feasibility of delivering SRT within a defined timeframe, risk of vertebral fractures, and need for additional radiation treatment.
Eligible patients will have an estimated life expectancy greater than six months. Strict radiation dose constraints will be applied to minimize the risk of spinal cord injury, and patient safety will be closely monitored, including implementation of an early stopping rule in case of unexpected severe toxicity.
The hypothesis of the study is that stereotactic radiotherapy will improve local control of spinal metastases compared with standard radiotherapy, without increasing the risk of serious adverse effects.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Loïg VAUGIER, MD
- 电话号码：+33 2 40 67 99 00
- 邮箱：Loïg.vaugier@ico.unicancer.fr
学习地点
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Angers、法国、49055
- Institut de Cancérologie de l'Ouest
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接触：
- Jeremy COLLIAUX, MD
- 电话号码：+33 2 41 35 27 00
- 邮箱：jeremy.colliaux@ico.unicancer.fr
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Avignon、法国、84918
- CLCC Ste Catherine - Institut du cancer Avignon/Provence
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接触：
- Pierre TREMOLIERES, MD
- 电话号码：+33 4 90 27 61 61
- 邮箱：p.tremolieres@isc84.org
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Brest、法国、29200
- CHU de Brest
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接触：
- Francois LUCIA, MD
- 电话号码：+33 2 98 22 33 33
- 邮箱：francois.lucia@univ-brest.fr
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La Roche-sur-Yon、法国、85000
- CHD Vendée
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接触：
- Emmanuelle REYGAGNE-VIERA, MD
- 电话号码：+33 2 51 44 61 61
- 邮箱：emmanuelle.reygagne-viera@ght85.fr
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Le Havre、法国、76600
- Centre Gillaume le Conquérant
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接触：
- Paul LESUEUR, MD
- 电话号码：+33 2 35 13 66 13
- 邮箱：p.lesueur@cglc.fr
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Le Mans、法国、72000
- Clinique Victor Hugo
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接触：
- Yoann POINTREAU, MD
- 电话号码：+33 2 55 46 37 00
- 邮箱：essaispointreau@ilcgroupe.fr
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Lorient、法国、56322
- Groupe Hospitalier Bretagne Sud (GHBS)
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接触：
- Guillaume BERA, MD
- 电话号码：+33 2 97 06 90 90
- 邮箱：g.bera@ghbs.bzh
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Rennes、法国、35760
- Institut de Cancérologie Radiothérapie Bretillien (ICRB)
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接触：
- Francois RIET, MD
- 电话号码：+33 2 99 23 33 33
- 邮箱：francois.riet@icrb.fr
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Rouen、法国、76038
- Centre Henri Becquerel
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接触：
- Sébastien THUREAU, MD
- 电话号码：+33 2 32 08 22 22
- 邮箱：sebastien.thureau@chb.unicancer.fr
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Saint-Herblain、法国、44805
- Institut de Cancérologie de l'Ouest
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接触：
- Martin LANGE, MD
- 电话号码：+33 2 40 67 99 00
- 邮箱：martin.lange@ico.unicancer.fr
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首席研究员：
- Martin LANGE, MD
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Saint-Nazaire、法国、44600
- Clinique Mutualiste de l'Estuaire
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接触：
- Vincent LIBOIS, MD
- 电话号码：+33 2 72 27 53 00
- 邮箱：vincent.libois@hospigrandouest.fr
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St-Malo、法国、35400
- Clinique de la Côte d'Emeraude
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接触：
- Nicolas JAKSIC, MD
- 电话号码：+33 2 23 52 20 20
- 邮箱：nicolas.jaksic@icrb.fr
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Tours、法国、37044
- CHRU Bretonneau
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接触：
- Astrid THOMIN, MD
- 电话号码：+33 2 47 47 47 76
- 邮箱：a.thomin@chu-tours.fr
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Vannes、法国、56000
- Clinique Saint Yves
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接触：
- Osman EL KABBAJ, MD
- 电话号码：+33 2 97 62 50 00
- 邮箱：o.elkabbaj@centre-st-yves.fr
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Histologically confirmed solid tumor;
- Vertebral bone metastasis located between C2 and S1 (inclusive) with epiduritis (spinal cord or cauda equina) without clinical and/or radiological spinal cord compression on MRI;
- Performance status (PS) ≤ 1;
- Spinal Instability Neoplastic Score (SINS) ≤12;
- Patient has been informed and has provided freely given, written, and signed informed consent;
- Patient is affiliated with or a beneficiary of the national health insurance system.
Exclusion Criteria:
- Neurological deficit attributable to spinal cord compression or cauda equina syndrome;
- Patient experiencing pain that prevents lying down for 30 minutes despite optimal analgesic treatment;
- Life expectancy ≤6 months as estimated by the investigator;
- Neurosurgical indication (preventive or decompressive) prior to radiotherapy;
- More than one epiduritis lesion requiring treatment;
- Prior surgery on the same vertebra targeted in the protocol;
- Epiduritis and/or bone lesion extending over more than three contiguous vertebral levels;
- Previous irradiation of the spine with cumulative dose with cumulative spinal cord dose EQD2 >50 Gy, α/β = 2;
- Contraindication to MRI;
- Pregnant or breastfeeding woman;
- Patient under legal protection, guardianship, or unable to provide informed consent;
- Inability to comply with study follow-up due to geographic, social, or psychological reasons.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Stereotactic Body Radiotherapy (SBRT)
Participants will receive SBRT in 5 fractions. Treatment includes:
Treatment planning will follow current guidelines with strict spinal cord and cauda equina dose constraints. |
Stereotactic body radiotherapy delivered in 5 fractions, consisting of 20 Gy to the involved vertebra and spinal canal (including adjacent hemi-vertebrae) with a simultaneous integrated boost to 35 Gy in 5 fractions to the tumor volume, according to protocol-defined delineation and dose constraints.
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有源比较器：Conventional Radiotherapy (palliative dose)
Participants will receive conventional external beam radiotherapy delivered in 5 fractions, with a total dose of 20 Gy to the involved vertebra and spinal canal, including adjacent superior and inferior hemi-vertebrae, consistent with standard palliative treatment. Radiotherapy will be administered according to the standard practice of the investigating center, with attention to treating any epidural extension visible on MRI. This arm is not intended for formal efficacy comparison but will support interpretation of study results and inform the design of a future comparative superiority trial if SRT demonstrates sufficient efficacy. |
Conventional external beam radiotherapy delivered in 5 fractions with a total dose of 20 Gy to the involved vertebra and spinal canal, including adjacent hemi-vertebrae, in accordance with standard palliative practice.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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1-year Clinical Disease Control Rate
大体时间：12 months after randomization
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Proportion of participants who are alive 12 months after randomization without clinical progression of the treated spinal lesion and without neurological deterioration attributable to the treated lesion during the 12-month follow-up.
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12 months after randomization
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合作者和调查者
调查人员
- 首席研究员：Loïg VAUGIER, MD、Institut de Cancérologie de l'Ouest
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.