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

Launched by AHS CANCER CONTROL ALBERTA · Jan 23, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with painful spinal metastases, which are cancerous growths that have spread to the spine. The study is exploring whether combining two treatments—radiotherapy (which uses radiation to target cancer cells) and vertebroplasty (a procedure that stabilizes the spine and reduces pain)—can provide better pain relief and improve overall function compared to radiotherapy alone. Researchers believe that this combination may help stabilize the spine, relieve pain more effectively, prevent further fractures, and reduce the need for strong pain medications.

To participate in this trial, patients must be at least 18 years old, have confirmed spinal metastases that cause significant pain, and have a life expectancy of more than six months. They should also be able to follow the study's treatment plan and attend scheduled visits. Participants can expect thorough monitoring throughout the trial and will have the opportunity to help shape a potential new standard of care for managing spinal metastases. This study is currently recruiting participants, and if successful, it could lead to improved treatment options for many patients facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Exclusion Criteria
• • 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