Comparing Radiotherapy with Vertebropladty for spinal metastases

Inclusion

• +Patients with an ECOG score 0-2 or Karnofsky performance status of ≥ 60% will be eligible for enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → (see appendix 1).
• +Participants capable of giving informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
• +Patients must be 18 years of age or older
• +Spinal vertebral metastases confirmed by CT, MRI or bone scan.
• +Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and /or lumbar spine (not cervical).
• +Patients must be willing and able to comply with schedule visits, treatment plan, tests and other study procedures
• +Life expectancy \> 6 months. Life expectancy will be evaluated by the study investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → both clinically and by using Linden model. Patient should be in the group B or C of the Linden model.
• +No prior EBRT to the target +/-1 vertebral body level
• +Male patients should agree to not donate sperm during study treatment.
• +Absence of any condition hampering compliance with study protocols and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → schedule; those conditions should be reviewed with the patient prior to trial registration
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +Patient cannot provide consent
• +Prior radiotherapy to the target +/-1 vertebral body level
• +Life expectancy \< 6 months (assessed both clinically and using Linden model)
• +Karnofsky performance status of \< 60%
• +Primary bone tumors
• +Plasmacytoma
• +Communicated fracture
• +Associated Impending cord compression or spinal cord compression
• +Epidural involvement
• +Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →. 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
• +Patients of childbearing / reproductive potential should use highly effective birth controlControl groupThe group a new treatment is measured against.Read more → 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) .
• +Females must not breastfeed during study treatment.