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NCT Number: NCT07656883

Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease

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.

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Key information

Conditions

Epiduritis Central Nervous System Diseases Nervous System Diseases Spinal Cord Compression Spinal Cord Diseases Spinal Cord Injuries Vertebral Bone Metastasis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de L'Ouest, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic body radiotherapy (SBRT)

Radiation

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.

Conventional External Beam Radiotherapy

Radiation

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.

Primary outcomes

1-year Clinical Disease Control Rate

Time frame: 12 months after randomization

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Loïg VAUGIER, MD

CONTACT

Loï[email protected]

+33 2 40 67 99 00

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Acronym: SPEED-RT

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Jun 18, 2026
Registry last updated: Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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