Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease (SPEED-RT)

June 16, 2026 updated by: Institut Cancerologie de l'Ouest

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49055
      • Avignon, France, 84918
        • CLCC Ste Catherine - Institut du cancer Avignon/Provence
        • Contact:
      • Brest, France, 29200
      • La Roche-sur-Yon, France, 85000
      • Le Havre, France, 76600
        • Centre Gillaume le Conquérant
        • Contact:
      • Le Mans, France, 72000
      • Lorient, France, 56322
        • Groupe Hospitalier Bretagne Sud (GHBS)
        • Contact:
          • Guillaume BERA, MD
          • Phone Number: +33 2 97 06 90 90
          • Email: g.bera@ghbs.bzh
      • Rennes, France, 35760
        • Institut de Cancérologie Radiothérapie Bretillien (ICRB)
        • Contact:
      • Rouen, France, 76038
      • Saint-Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest
        • Contact:
        • Principal Investigator:
          • Martin LANGE, MD
      • Saint-Nazaire, France, 44600
      • St-Malo, France, 35400
        • Clinique de la Côte d'Emeraude
        • Contact:
      • Tours, France, 37044
        • CHRU Bretonneau
        • Contact:
      • Vannes, France, 56000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: 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.
Active Comparator: 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.
Radiation: Conventional External Beam Radiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Loïg VAUGIER, MD, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2024-27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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