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L'essai clinique NCT04242589 pour Métastases spinales est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions Phase II 64

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT04242589 est conçu pour étudier le traitement de Métastases spinales. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : en recrutement. L'étude a débuté le 3 mars 2021 et vise à recruter 64 participants. Dirigée par AHS Cancer Control Alberta, l'étude devrait être terminée d'ici le 1 novembre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 26 juin 2025.
Résumé succinct
Since patients with spinal metastases are living longer, durable palliation with long-term tumor control are becoming increasingly important.

EBRT results in durable local control of bone metastasis. However, about 25 % of patients with spinal metastases only achieved complete pain relief following EBRT for a median duration of less than 4 months. This could be partly due to spinal instability. In addition, almost h...

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Titre officiel

A Phase II Randomized Trial of Combined Radiotherapy and Vertebroplasty to Improve the Quality of Life of Patients With Painful Metastatic Localized Spinal Lesions

Pathologies
Métastases spinales
Autres identifiants de l'étude
  • IIT-0008
Numéro NCT
NCT04242589
Date de début (réel)
2021-03-03
Dernière mise à jour publiée
2025-06-26
Date de fin (estimée)
2027-11-01
Inscription (estimée)
64
Type d'étude
Interventionnel
PHASE
Phase II
Statut
En recrutement
Mots clés
Vertebroplasty
Vertebral Compression Fracture
Radiotherapy
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Étude croisée
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actifRadiotherapy
Radiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist)
Radiothérapie
External beam radiation therapy is a type of radiation therapy used for cancer treatment. A machine is used to aim high-energy rays from outside the body into tumor
ExpérimentalVertebroplasty + Radiotherapy
Vertebroplasty followed by radiotherapy within 2-3 weeks Radiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist)
Radiothérapie
External beam radiation therapy is a type of radiation therapy used for cancer treatment. A machine is used to aim high-energy rays from outside the body into tumor
Vertebropladty
Vertebroplasty is a procedure for stabilizing compression fractures in the spine. Bone cement is injected into vertebrae that have cracked or broken. The cement hardens, stabilizing the fractures and supporting your spine.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Improvement in Pain Score based on the Visual Analog Scale
The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the visual analogue Scale (VAS) without concurrent increase in opioids.
1,3,6 and 12 months post treatment
Improvement in Pain Score based on the Brief Pain Inventory
The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the Brief Pain Inventory (BPI) without concurrent increase in opioids.
1,3,6 and 12 months post treatment
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Changes in back-specific physical functioning
The improvement in back-specific physical functioning is evaluated by the change in Roland-Morris disability questionnaire (RDQ) score.
1,3,6 and 12 months post treatment
Incidence of vertebral compression fractures post treatment.
The incidence of vertebral compression fractures will be evaluated by standing lateral spine radiographs of the thoracic and lumbar vertebrae.
Baseline, 6 months and 12 months
Prospectively quantify pain response using the Visual Analog Scale
Pain response will be assessed by VAS and evaluated using a patient diary based on the International Bone Metastases Working Party Criteria. Based on intake of analgesics, the daily oral morphine equivalent dose (OMED) will be calculated.
1,3,6 and 12 months post treatment
Prospectively quantify pain response using the Brief Pain Inventory.
Pain response will be assessed by BPI and evaluated using a patient diary based on the International Bone Metastases Working Party Criteria. Based on intake of analgesics, the daily oral morphine equivalent dose (OMED) will be calculated.
1,3,6 and 12 months post treatment
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  1. Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
  2. Patients must be 18 years of age or older
  3. Spinal vertebral metastases confirmed by CT, MRI or bone scan.
  4. Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and /or lumbar spine (not cervical).
  5. Patients must be willing and able to comply with schedule visits, treatment plan, tests and other study procedures
  6. Life expectancy > 6 months. Life expectancy will be evaluated by the study investigator both clinically and by using Linden model. Patient should be in the group B or C of the Linden model.
  7. Patients with an ECOG score 0-2 or Karnofsky performance status of ≥ 60% will be eligible for enrolment (see appendix 1).
  8. No prior EBRT to the target +/-1 vertebral body level
  9. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause
  10. Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard) .
  11. Females must not breastfeed during study treatment.
  12. Male patients should agree to not donate sperm during study treatment.
  13. Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration

  1. Patient cannot provide consent
  2. Prior radiotherapy to the target +/-1 vertebral body level
  3. Life expectancy < 6 months (assessed both clinically and using Linden model)
  4. Karnofsky performance status of < 60%
  5. Primary bone tumors
  6. Plasmacytoma
  7. Communicated fracture
  8. Associated Impending cord compression or spinal cord compression
  9. Epidural involvement
AHS Cancer Control Alberta logoAHS Cancer Control Alberta
Cross Cancer Institute logoCross Cancer Institute
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays

Alberta

Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Kurian Joseph, MD, Contact, 780-432-8755, [email protected]
Kurian Joseph, MD, Investigateur principal
En recrutement