VErtebroplasty versus Radiotherapy As palliative treatment of vertebral metastases of Multiple Myeloma (M. Kahler)
| ISRCTN | ISRCTN48083859 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48083859 |
| Protocol serial number | CCMO NL14746.078.07; Erasmus MC METC 2007-033 |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Funder | Erasmus Medical Centre (The Netherlands) |
- Submission date
- 27/06/2007
- Registration date
- 27/06/2007
- Last edited
- 26/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Radiology Hs-220
Erasmus MC - University Medical Center Rotterdam
's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
| Phone | +31 (0)10 463 2886 |
|---|---|
| e.vanderlinden@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | VERAMM |
| Study objectives | Vertebroplasty improves the quality of life of the individual patient by increased pain reduction and restoration of mobility. Vertebroplasty also reduces costs, as it decreases the number of inpatient days, the number of outpatient visits and follow-up treatments, and the need for home care. |
| Ethics approval(s) | The VERAMM trial was approved by the Medical Ethics Committee Erasmus MC (METC) on the 15th March 2007 (ref: MEC-2007-033). |
| Health condition(s) or problem(s) studied | Spinal metastases, vertebroplasty, multiple myeloma |
| Intervention | Arm I (control): radiotherapy (20 Gy) of affected vertebrae Arm II: vertebroplasty of affected vertebrae |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Degree of pain (VAS-pain score, scale: 0 - 10), measured at day 0 (pre-treatment), day 0 (post-treatment), day 7, week 4, week 12, month 6 and year 1 |
| Key secondary outcome measure(s) |
1. Initial technical success and complications, measured at day 0 (post-treatment) and week 4 respectively |
| Completion date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 104 |
| Key inclusion criteria | 1. Persistent pain caused by vertebral metastases from myeloma (including plasmacytoma) with Visual Analogue Scale (VAS) score greater than 4 (scale: 1-10) 2. Informed consent 3. Older than 18 years |
| Key exclusion criteria | 1. Greater than four affected vertebrae 2. Vertebral fracture through back wall with retropulsion that consumes more than 33% of the spinal channel 3. Myelum compression with neurological degeneration: Frankel A/B 4. Epiduritis 5. Incorrigible coagulopathy 6. Karnofsky score less than 30 (moribund) |
| Date of first enrolment | 04/06/2007 |
| Date of final enrolment | 01/03/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3015 CE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
