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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR987 |
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Date of registration:
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04/06/2007 |
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Primary sponsor: |
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Public title:
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Vertebroplasty versus radiotherapy as palliative treatment of vertebral metastases of multiple myeloma (M. Kahler)
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Scientific title:
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Vertebroplasty versus radiotherapy as palliative treatment of vertebral metastases of multiple myeloma (M. Kahler)
- VERAMM |
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Date of first enrolment:
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4/6/2007 |
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Target sample size:
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104 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=987 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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P.M.T.
Pattynama |
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Address:
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Department of Radiology
Erasmus MC
?s-Gravendijkwal 230
3015 CE
Rotterdam
The Netherlands |
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Telephone:
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+31 10-4632886 |
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Email:
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p.m.t.pattynama@erasmusmc.nl |
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Affiliation:
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Name:
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Research Office, Erasmus MC Dept of Radiology |
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Address:
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Research Office
Erasmus MC Dept of Radiology
?s Gravendijkwal 230
3015 CE
Rotterdam
The Netherlands |
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Telephone:
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+31-10-463-2277 |
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Email:
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research.radiology@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Persistent pain caused by vertebral metastases from myeloma (including plasmacytoma) with VAS score >4 (scale: 1-10);
2. Informed consent;
3. Older than 18 years;
Exclusion criteria: 1. >4 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 <30 (moribund);
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Multiple myeloma (Kahler's disease), Vertebroplasty, Spinal metastases
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Intervention(s)
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Arm I (control):
radiotherapy (20 Gy) of affected vertebrae
Arm II:
vertebroplasty of affected vertebrae
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Primary Outcome(s)
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1. Degree of pain (VAS-pain score, scale: 0-10; pre-treatment and first 7 days post procedure);
2. Use of pain medication (pretreatment and day 0,day 7, week 4, week 12, month 6, year 1 after treatment)
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Secondary Outcome(s)
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1. Initial technical success & complications
Mobility (Oswestry-daily activity scale);
2. Quality of life (questionnaires:EORTC QLQ-MY24, SF-36);
3. Collapse of treated vertebrae (lateral X-WK)
4. Mortality
5. Direct medical costs (e.g. procedure costs, hospitalisation days, pain medication, secondary interventions, revalidation or nursing home costs, follow-up)
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Secondary ID(s)
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CCMO NL14746.078.07; Erasmus MC METC 2007-033
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ISRCTN48083859
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Source(s) of Monetary Support
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Erasmus Medical Center, department of Radiology
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