Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease

NCT07656883 | Not Yet Recruiting DMC

• 1 other identifier: ICO-2024-27
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 14

Brief 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). 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.

Conditions

Epiduritis; Vertebral Bone Metastasis

Keywords

Epidural Disease; Spinal Cord Compression; Palliative Radiotherapy; Spinal Metastases; Stereotactic Body Radiotherapy (SBRT); Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after randomization

Study Arms (2)

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.

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.

Radiation: Conventional External Beam Radiotherapy

Interventions

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.

Stereotactic Body Radiotherapy (SBRT)

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.

Conventional Radiotherapy (palliative dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (14)

Institut de Cancerologie de L'Ouest

Angers, 49055, France

Location

CLCC Ste Catherine - Institut du cancer Avignon/Provence

Avignon, 84918, France

Location

Chu de Brest

Brest, 29200, France

Location

CHD Vendée

La Roche-sur-Yon, 85000, France

Location

Centre Gillaume le Conquérant

Le Havre, 76600, France

Location

Clinique Victor Hugo

Le Mans, 72000, France

Location

Groupe Hospitalier Bretagne Sud (GHBS)

Lorient, 56322, France

Location

Institut de Cancérologie Radiothérapie Bretillien (ICRB)

Rennes, 35760, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

Clinique mutualiste de l'Estuaire

Saint-Nazaire, 44600, France

Location

Clinique de la Côte d'Emeraude

St-Malo, 35400, France

Location

Chru Bretonneau

Tours, 37044, France

Location

Clinique Saint Yves

Vannes, 56000, France

Location

MeSH Terms

Conditions

Spinal Cord Compression

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Loïg VAUGIER, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loïg VAUGIER, MD

CONTACT

+33 2 40 67 99 00; Loïg.vaugier@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

FR (14)