Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease (SPEED-RT)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Loïg VAUGIER, MD
- Telefonnummer: +33 2 40 67 99 00
- E-post: Loïg.vaugier@ico.unicancer.fr
Studiesteder
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Angers, Frankrike, 49055
- Institut de Cancérologie de l'Ouest
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Ta kontakt med:
- Jeremy COLLIAUX, MD
- Telefonnummer: +33 2 41 35 27 00
- E-post: jeremy.colliaux@ico.unicancer.fr
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Avignon, Frankrike, 84918
- CLCC Ste Catherine - Institut du cancer Avignon/Provence
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Ta kontakt med:
- Pierre TREMOLIERES, MD
- Telefonnummer: +33 4 90 27 61 61
- E-post: p.tremolieres@isc84.org
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Brest, Frankrike, 29200
- CHU de Brest
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Ta kontakt med:
- Francois LUCIA, MD
- Telefonnummer: +33 2 98 22 33 33
- E-post: francois.lucia@univ-brest.fr
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La Roche-sur-Yon, Frankrike, 85000
- CHD Vendée
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Ta kontakt med:
- Emmanuelle REYGAGNE-VIERA, MD
- Telefonnummer: +33 2 51 44 61 61
- E-post: emmanuelle.reygagne-viera@ght85.fr
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Le Havre, Frankrike, 76600
- Centre Gillaume le Conquérant
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Ta kontakt med:
- Paul LESUEUR, MD
- Telefonnummer: +33 2 35 13 66 13
- E-post: p.lesueur@cglc.fr
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Le Mans, Frankrike, 72000
- Clinique Victor Hugo
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Ta kontakt med:
- Yoann POINTREAU, MD
- Telefonnummer: +33 2 55 46 37 00
- E-post: essaispointreau@ilcgroupe.fr
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Lorient, Frankrike, 56322
- Groupe Hospitalier Bretagne Sud (GHBS)
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Ta kontakt med:
- Guillaume BERA, MD
- Telefonnummer: +33 2 97 06 90 90
- E-post: g.bera@ghbs.bzh
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Rennes, Frankrike, 35760
- Institut de Cancérologie Radiothérapie Bretillien (ICRB)
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Ta kontakt med:
- Francois RIET, MD
- Telefonnummer: +33 2 99 23 33 33
- E-post: francois.riet@icrb.fr
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Rouen, Frankrike, 76038
- Centre Henri Becquerel
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Ta kontakt med:
- Sébastien THUREAU, MD
- Telefonnummer: +33 2 32 08 22 22
- E-post: sebastien.thureau@chb.unicancer.fr
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Saint-Herblain, Frankrike, 44805
- Institut de Cancérologie de l'Ouest
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Ta kontakt med:
- Martin LANGE, MD
- Telefonnummer: +33 2 40 67 99 00
- E-post: martin.lange@ico.unicancer.fr
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Hovedetterforsker:
- Martin LANGE, MD
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Saint-Nazaire, Frankrike, 44600
- Clinique Mutualiste de l'Estuaire
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Ta kontakt med:
- Vincent LIBOIS, MD
- Telefonnummer: +33 2 72 27 53 00
- E-post: vincent.libois@hospigrandouest.fr
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St-Malo, Frankrike, 35400
- Clinique de la Côte d'Emeraude
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Ta kontakt med:
- Nicolas JAKSIC, MD
- Telefonnummer: +33 2 23 52 20 20
- E-post: nicolas.jaksic@icrb.fr
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Tours, Frankrike, 37044
- CHRU Bretonneau
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Ta kontakt med:
- Astrid THOMIN, MD
- Telefonnummer: +33 2 47 47 47 76
- E-post: a.thomin@chu-tours.fr
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Vannes, Frankrike, 56000
- Clinique Saint Yves
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Ta kontakt med:
- Osman EL KABBAJ, MD
- Telefonnummer: +33 2 97 62 50 00
- E-post: o.elkabbaj@centre-st-yves.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Stereotactic Body Radiotherapy (SBRT)
Participants will receive SBRT in 5 fractions. Treatment includes:
Treatment planning will follow current guidelines with strict spinal cord and cauda equina dose constraints. |
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.
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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. |
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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1-year Clinical Disease Control Rate
Tidsramme: 12 months after randomization
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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.
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12 months after randomization
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Loïg VAUGIER, MD, Institut de Cancérologie de l'Ouest
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ICO-2024-27
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