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

16. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

167

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Stråling: 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.
Aktiv komparator: 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.
Stråling: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1-year Clinical Disease Control Rate
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institut Cancerologie de l'Ouest

Efterforskere

  • Ledende efterforsker: Loïg VAUGIER, MD, Institut de Cancérologie de l'Ouest

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. oktober 2029

Studieafslutning (Anslået)

1. oktober 2030

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ICO-2024-27

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Stereotactic Body Radiotherapy (SBRT)

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Betingelser

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Kosttilskud

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Placeringer

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