NCT00294151

Brief Summary

The study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. The investigators hypothesize that, by combining vertebral augmentation with cement and radiotherapy, they could achieve an enhancement in pain relief and level of activities, as well as a decrease in the side effects of multiple medications used for pain control.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
Last Updated

July 13, 2007

Status Verified

January 1, 2006

First QC Date

February 17, 2006

Last Update Submit

July 12, 2007

Conditions

Breast CancerProstate CancerVertebral MetastasisPain

Keywords

breast cancerprostate cancervertebral metastasisvertebroplastyvertebral metastasis from breast cancervertebral metastasis from prostate cancer

Outcome Measures

Primary Outcomes (1)

  • pain relief; score on pain questionnaire

    at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

Secondary Outcomes (6)

  • quality of life; score on 2 quality of life questionnaires

    at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

  • pain medication

    listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

  • side effects

    listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

  • cost of medical care

    evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

  • survival

    recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after

  • +1 more secondary outcomes

Interventions

VertebroplastyPROCEDURE

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 35 and 75 years old
  • Biopsy-proven breast cancer (BC) or prostate cancer (PC)
  • Radiographic evidence of spine metastases from the BC or PC in the lumbar and/or mid-low thoracic spine
  • Microfractures or compression fractures up to 40% of the original height of the vertebral body in an MRI \[magnetic resonance imaging\] (reported by an independent radiologist)
  • Incidental back pain (Verbal Analog Scale \> 5/10) felt to be related to those metastases

You may not qualify if:

  • Spinal cord compression
  • Massive rupture of the posterior wall of the vertebral body (according to blinded radiological report)
  • Coagulopathy (International Normalized Ratio \[INR\] \> 1.5, platelets \< 80,000)
  • Inability to communicate in English, French or Spanish
  • Previous radiotherapy to the spine in the area presently affected
  • Mental cognitive impairment
  • Vertebral metastasis without fracture in the MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Related Publications (6)

  • Saarto T, Janes R, Tenhunen M, Kouri M. Palliative radiotherapy in the treatment of skeletal metastases. Eur J Pain. 2002;6(5):323-30. doi: 10.1016/s1090-3801(02)00028-9.

    PMID: 12160506BACKGROUND

  • Wu JS, Bezjak A, Chow E, Kirkbride P. Primary treatment endpoint following palliative radiotherapy for painful bone metastases: need for a consensus definition? Clin Oncol (R Coll Radiol). 2002 Feb;14(1):70-7. doi: 10.1053/clon.2001.0012.

    PMID: 11899906BACKGROUND

  • McQuay HJ. The Cochrane Database of Systematic Reviews 3:---,2003.

    BACKGROUND

  • McLain R. Tumors of the Spine. In Herkowitz H et al. The Spine Philadelphia, WB Saunders Co 1171-1206, 1999.

    BACKGROUND

  • Niv D, Gofeld M, Devor M. Causes of pain in degenerative bone and joint disease: a lesson from vertebroplasty. Pain. 2003 Oct;105(3):387-392. doi: 10.1016/S0304-3959(03)00277-X.

    PMID: 14527699BACKGROUND

  • Molloy S, Mathis JM, Belkoff SM. The effect of vertebral body percentage fill on mechanical behavior during percutaneous vertebroplasty. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1549-54.

    PMID: 12865843BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsPain

Interventions

Vertebroplasty

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CementoplastyOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Juan F Asenjo, MD

    Montreal General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan F Asenjo, MD

CONTACT

514-934-1934jfasenjog@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2006

First Posted

February 20, 2006

Study Start

September 1, 2005

Last Updated

July 13, 2007

Record last verified: 2006-01

Locations

CA(1)