EpiduritisSPEED-RTNCT07656883
Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease
A study testing Stereotactic Body Radiotherapy (SBRT) and Conventional External Beam Radiotherapy in people with Epiduritis and Vertebral Bone Metastasis, run by Institut Cancerologie de l'Ouest at 14 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiduritis, Vertebral Bone Metastasis
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT) and Conventional External Beam Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 14 sitesFrance
- Study dates
- Oct 2026to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites
Institut de Cancerologie de L'Ouest
Angers, 49055
Jeremy COLLIAUX, MD, +33 2 41 35 27 00, jeremy.colliaux@ico.unicancer.fr
CLCC Ste Catherine - Institut du cancer Avignon/Provence
Avignon, 84918
Pierre TREMOLIERES, MD, +33 4 90 27 61 61, p.tremolieres@isc84.org
Chu de Brest
Brest, 29200
Francois LUCIA, MD, +33 2 98 22 33 33, francois.lucia@univ-brest.fr
CHD Vendée
La Roche-sur-Yon, 85000
Emmanuelle REYGAGNE-VIERA, MD, +33 2 51 44 61 61, emmanuelle.reygagne-viera@ght85.fr
Centre Gillaume le Conquérant
Le Havre, 76600
Paul LESUEUR, MD, +33 2 35 13 66 13, p.lesueur@cglc.fr
Clinique Victor Hugo
Le Mans, 72000
Yoann POINTREAU, MD, +33 2 55 46 37 00, essaispointreau@ilcgroupe.fr
Groupe Hospitalier Bretagne Sud (GHBS)
Lorient, 56322
Guillaume BERA, MD, +33 2 97 06 90 90, g.bera@ghbs.bzh
Institut de Cancérologie Radiothérapie Bretillien (ICRB)
Rennes, 35760
Francois RIET, MD, +33 2 99 23 33 33, francois.riet@icrb.fr
Centre Henri Becquerel
Rouen, 76038
Sébastien THUREAU, MD, +33 2 32 08 22 22, sebastien.thureau@chb.unicancer.fr
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Martin LANGE, MD, +33 2 40 67 99 00, martin.lange@ico.unicancer.fr
Martin LANGE, MD
Clinique mutualiste de l'Estuaire
Saint-Nazaire, 44600
Vincent LIBOIS, MD, +33 2 72 27 53 00, vincent.libois@hospigrandouest.fr
Clinique de la Côte d'Emeraude
St-Malo, 35400
Nicolas JAKSIC, MD, +33 2 23 52 20 20, nicolas.jaksic@icrb.fr
Chru Bretonneau
Tours, 37044
Astrid THOMIN, MD, +33 2 47 47 47 76, a.thomin@chu-tours.fr
Clinique Saint Yves
Vannes, 56000
Osman EL KABBAJ, MD, +33 2 97 62 50 00, o.elkabbaj@centre-st-yves.fr
About this study
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.
Read more
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.
- Conditions
- Epiduritis, Vertebral Bone Metastasis
- Being tested
- Stereotactic Body Radiotherapy (SBRT), Conventional External Beam Radiotherapy
- Keywords
- Epidural Disease, Spinal Cord Compression, Palliative Radiotherapy, Spinal Metastases, Stereotactic Body Radiotherapy (SBRT), Radiation Therapy
- Medical subject headings
- Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Participants will receive SBRT in 5 fractions. Treatment includes:
* 20 Gy in 5 fractions to the involved vertebra and spinal canal, including adjacent superior and inferior hemi-vertebrae (elective volume), corresponding to a standard palliative dose; and
* A simultaneous integrated boost to the tumor volume, defined per protocol guidelines, delivering 35 Gy in 5 fractions (7 Gy per fraction).
Treatment planning will follow current guidelines with strict spinal cord and cauda equina dose constraints. Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
| Conventional Radiotherapy (palliative dose) | Active comparator | 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. Receives: Radiation: Conventional External Beam Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Clinical Disease Control Rate
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.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpiduritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïg VAUGIER, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656883
- Sponsor's protocol ID
- ICO-2024-27
- Acronym
- SPEED-RT
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease
- ClinicalTrials.gov ID
- NCT07656883
- Acronym / sponsor ID
- SPEED-RT / ICO-2024-27
- Conditions
- Epiduritis, Vertebral Bone Metastasis
- Keywords
- Epidural Disease, Spinal Cord Compression, Palliative Radiotherapy, Spinal Metastases, Stereotactic Body Radiotherapy (SBRT), Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT)Participants will receive SBRT in 5 fractions. Treatment includes: * 20 Gy in 5 fractions to the involved vertebra and spinal canal, including adjacent superior and inferior hemi-vertebrae (elective volume), corresponding to a standard palliative dose; and * A simultaneous integrated boost to the tumor volume, defined per protocol guidelines, delivering 35 Gy in 5 fractions (7 Gy per fraction). Treatment planning will follow current guidelines with strict spinal cord and cauda equina dose constraints. |
| Conventional Radiotherapy (palliative dose) | Active comparator | Radiation: Conventional External Beam RadiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT)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. | Radiation | Stereotactic Body Radiotherapy (SBRT) |
| Conventional External Beam RadiotherapyConventional 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. | Radiation | Conventional Radiotherapy (palliative dose) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Loïg VAUGIER, MD principal investigator
Institut de Cancérologie de l'Ouest
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiotherapy (SBRT) and Conventional External Beam Radiotherapy in people with Epiduritis and Vertebral Bone Metastasis, run by Institut Cancerologie de l'Ouest at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loïg VAUGIER, MD (+33 2 40 67 99 00, Loïg.vaugier@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Clinical Disease Control Rate (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.