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Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions Fase 2 64

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De klinische studie NCT04242589 onderzoekt behandeling bij Ruggenmergmetastasen. Deze Fase 2 interventioneel-studie heeft de status rekruterend. Het doel is om 64 deelnemers te includeren vanaf 3 maart 2021. De studie wordt geleid door AHS Cancer Control Alberta en de voltooiing is gepland op 1 november 2027. Laatste update op ClinicalTrials.gov: 26 juni 2025.
Beknopte samenvatting
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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Officiële titel

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

Aandoeningen
Ruggenmergmetastasen
Andere studie-ID's
  • IIT-0008
NCT-ID
NCT04242589
Startdatum (Werkelijk)
2021-03-03
Laatste update geplaatst
2025-06-26
Verwachte einddatum
2027-11-01
Inschrijving (Geschat)
64
Studietype
Interventioneel
FASE
Fase 2
Status
Rekruterend
Trefwoorden
Vertebroplasty
Vertebral Compression Fracture
Radiotherapy
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Actieve comparatorRadiotherapy
Radiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist)
Radiotherapie
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
ExperimenteelVertebroplasty + 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)
Radiotherapie
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.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  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
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen

Alberta

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