Combining radiotherapy and vertebroplasty for painful spinal metastases

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

This study is testing whether combining radiation therapy with a procedure to stabilize the spine can help people with painful spinal cancer feel better and improve their overall function.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AHS Cancer Control Alberta (Academic / other)
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT04242589 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining radiotherapy with vertebroplasty in patients suffering from painful metastatic spinal lesions. The approach aims to provide both pain relief and stabilization of the spine, addressing the limitations of each treatment when used alone. By integrating these two interventions, the study seeks to improve patient outcomes, particularly in preventing vertebral compression fractures and reducing reliance on opioids. Participants will be monitored for pain relief and overall function following the combined treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed painful spinal metastases and a life expectancy of more than six months.

Not a fit: Patients with cervical spinal metastases or those who have previously received external beam radiotherapy to the target vertebral levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance pain management and spinal stability for patients with metastatic spinal lesions.

How similar studies have performed: While the combination of these treatments is innovative, previous studies have shown success with each intervention separately, suggesting potential for this novel approach.

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

Where this trial is running

Edmonton, Alberta

• Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)

Conditions Spinal Metastases; Vertebroplasty; Vertebral Compression Fracture; Radiotherapy